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Guidelines of care for acne vulgaris
Academy guidelines American Academy of Dermatology guidelines development: An overview During the presidency of Clayton E. Wheeler, MD, the Task Force on Professional Guidelines was established. However, increasing requests for hospital credentialing guidelines strongly influenced the group chaired by Lynn A. Drake, MD, to focus its attention on developing a document to address this issue. In 1987 the credentialing and privileging report was completed; it was released in January 1988. The ongoing pressure to develop guidelines of care by other groups, both medical and nonmedical, led then-President G. Thomas Jansen, MD, to expand the Task Force's charge and to change its title--The Task Force on Standards of Care. In January 1988, it identified five diseases and one procedure for guidelines development: acne vulgaris, atopic dermatitis, basal cell carcinoma, benign pigmented lesions, systemic treatment of psoriasis, and liposuction. A consensus conference including Task Force and key Academy members was conducted by David M. Eddy, PhD, to begin the process. Dr. Eddy, a nationally renowned expert in guidelines development, has worked with several other national medical specialty groups. At the conclusion of this intense 2-day seminar, initial drafts were ready for review and comment by a variety of Academy members-topic experts and general practitioners. This process permitted the guidelines to reflect accurately the spectrum of acceptable treatments provided by dermatologists. It is important to note here that all materials included in AAD guidelines are documented and supported by peer-reviewed literature. During the remainder of 1988, the guidelines continued to undergo rigorous review by the Task Force, which had been elevated to Committee status, by those expert in the subject areas, and by the AAD Board of Directors. At its April 1989 meeting, the Board approved the guidelines for acne vulgaris and liposuction, which were then published in the AAD Bulletin. In September 1989, the Academy's Board of Directors approved, in principle, five additional guidelines that will be presented to the membership for review and comment in future issues of the Bulletin. The Board also agreed that all guidelines would be submitted to this JOURNAL for publication. Thus the following is the first in an ongoing series. Guidelines of care for liposuction will be published in the JOURNAL later this year. The Committee on Guidelines of Care continues to work on nine more topics.
--Lynn A. Drake. MD
This report reflects the best data available at the time the report was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alteration of the conclusions or recommendations set forth in this report.
Guidelines of care for acne vulgaris* Committee on Guidelines ofCare: Lynn A. Drake, MD, chairman, Roger I. Ceilley, MD, Raymond L. Cornelison, MD, William. L. Dobes, MD, William Dorner, MD, Charles W. Lewis, MD, Stuart 1. Salasche, MD, and Maria L. Chanco Turner, MD Task Force on Acne Vulgaris: Peter E. Pochi, MD, chairman, Ralph J. Coskey, MD, Edward A. Krull, MD, Orlando G. Rodman, MD, Maria L. Chanco Turner, MD, and Stephen B. Webster, MD Task Force on Accutane: Peter E. Pochi, MD, chairman, Ralph J. Caskey, MD, Lynn A. Drake, MD, G. Thomas Jansen, MD, Roger I. Ceilley, MD, Orlando G. Rodman, MD, Maria L. Chanco Turner, MD, and Stephen B. Webster, MD Reprintrequests: Lynn A. Drake,MD, Dept.ofDermatology, Bartlett4, Massachusetts General Hospital, Boston, MA 07090. *Approved April 1989.
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I. Introduction The American Academy of Dermatology's Committee on Guidelines of Care is developing guidelines of care for our profession. The development of guide-
Volume 22 Number 4 April 1990
lines will promote the continued delivery of quality care and assist those outsideour profession in understanding the complexities and boundaries of care provided by dermatologists. II. Definition Acnevulgarisis a follicular disorder that affectssusceptiblepilosebaceous follicles, primarilyof the face, neck, and upper trunk, and is characterized by both noninflammatory and inflammatory lesions. III. Rationale A. Scope Acne is a disease of high prevalence and affects many persons in their teen age years. Although peak prevalencemay be at age 17,acne may begin as early as age 8 and is not uncommonin the 10- to 12-year-oldage group in which it is often overlooked. Both sexes are affectedequally, but males have, on average,greater degreesof severity. A substantial percentage of adults are affected either as a continuation of their teenage acne Or its first appearance in the third or fourth decade. Most cases of acne subsideand involute spontaneously and completely withina fewyears of their onset, but a small percentageremain active. The disease may cause considerable emotional distress because of its appearance, even when the disease has involuted if scarring has taken place. The psychosocial impact on teenagers may be devastating. B. Issue Acne vulgaris is a conditionof unknown origin; however, multiple factors are known to contribute to its pathogenesis and its aggravation. Althoughthere is no known predictablecure for the disease, numerous therapies are available that can substantially control its activity in most cases. IV. Diagnosticcriteria A. Clinical 1. Patient history To determine appropriatetreatment a patient history should be taken. Information to be gathered may includethe following: a) Duration, to includeprogression to pointof maximal severity b) Location c) Seasonal variation d) Aggravation by stress e) For women (1) Premenstrual flare-up (2) Menstrual history and pregnancy status (3) Increase of androgen-dependent hair (4) Thinning of scalp hair (5) Oral contraceptives and effect on acne (6) Hormone tests
Guidelines: Acne vulgaris 677 (7) Cosmetics and moisturizers: type and frequency fJ Current treatment(s): topical and systemic (1) Of acne (2) Of other diseases g) Past treatment(s): topical and systemic (1) Of acne (2) Of other diseases h) Family history of acne i) Other skin disorders, especially but not limited to: (1) Atopy,personalor familial (becauseof occasional irritation to topical acne preparations) (2) Hidradenitis suppurativa j) Drug allergies k) General health, especially but not limited to: (1) Hepatic disease (2) Renal disease (3) Endocrine 2. Physical examination Establishment of diagnosis should occurafter reviewof the patient history and physicalexamination of the patient for the clinicalcriteria of acne. 3. Lesion type aJ Noninflammatory (I) Open comedones (2) Closed comedones b) Inflammatory (1) Papules (2) Pustules (3) Nodules and/or cysts 4. Location a) Face/neck b) Back c) Anterior chest d) Extremities 5. Gradation a) Mild, moderate, severe b) For each predominant lesion type c) Location 6. Complications a) Scarring type (1) Atrophic (a) Localization (b) Severity (c) Discoloration (2) Hypertrophic (a) Localization (b) Severity (c) Discoloration (3) Keloids (a) Localization (b) Severity
678 Drake et al. (c) Discoloration b) Scarring grade (l ) Definition (2) Location (3) Degree 7. Other associated findings include but are not limited to a) Postinflammatory macular lesions b) Postinflammatory hyperpigmentation and hypopigmentation c) Hirsutism for women d) Alopecia for women e) Asymmetry of distribution of acne jJ Excoriations B. Diagnostic tests There are no diagnostic tests for acne vulgaris. However, in some instances diagnostic tests are used to differentiate and identify acnelike eruptions or to detect the presence of systemic conditions that aggravate acne. Such tests include but are not limited to 1. Bacteria culture (e.g., gram-negative folliculitis) 2. Hormonal assay (e.g., presence of androgen imbalance) 3. Biopsy when necessary to differentiate acne from other diseases C . Inappropriate diagnostic tests" 1. Routine allergy testing 2. Hair analysis D. Exceptions Not applicable E . Evolving diagnostic test Not applicable V. Recommendations A. Treatment Topical treatment alone may be indicated for the following types of acne: mild to moderate comedonal lesions, superficial inflammatory (papular or pustular), and usually nonscarring. In addition, systemic treatment may be indicated for the following types of acne: moderate to severe (scarring or nonscarring) or that in patients with persistent hyperpigmentation. Systemic trea tment may need to be used alone in patients who are intolerant to topical treatment or in whom such treatment has failed. 1. Nonsurgical a) Topical therapy: most commonly used , but not limited to ( 1) Benzoyl peroxide ( 2) Benzoyl peroxide-erythromycin ( 3) Benzoyl peroxide-sulfur ( 4) Topical antibiotics "The tests listed are examples.
Journal of the American Academy of Dermatology
(a) Tetracycline lotion (b) Clindamycin lotion, gel
(c) Erythromycin lotion, swabs, gel (d) Meclocycline cream ( 5) Tretinoin ( 6) Salicylic acid ( 7) a-Hydroxy acid ( 8) Sulfur: including Vleminckx's solution ( 9) Resorcinol (10) Miscellaneous: astringents, soaps, cleansers b) Systemic therapy: most commonly used, but not limited to (1) Antibiotics, oral (a) Tetracycline (b) Erythromycin (c) Minocycline (dJ Trimethoprim-sulfamethoxazole (e) Other (2) Isotretinoin, oral Primary and only approved use is for severe, recalcitrant, cystic acne, refractory to conventional anti-acne measures, including systemic antibiotics. For women of childbearing potential, Appendix A guidelines apply. (3) Hormonal treatments may include the following: (a) Corticosteroids i) Anti-inflanunatory actions: high dose ii) Androgen suppressant action: low dose (b) Sex hormones (for women only) i) Estrogen (oral contraceptive medication) (e) Antiandrogens (4) Other treatments may include the following: (a) Dapsone (b) Diet (in selected cases) (e) Ultraviolet light (d) Superficial exfoliation i) Carbon dioxide-acetone slush ii) Sulfur-resorcinol iii) Chemical 2. Surgical a) Lesional therapy (1) Extraction of comedonal contents (2) Drainage of superficial pustules and cysts (3) Excision of sinus tracts and cysts b) Intralesional corticosteroids c) Cryotherapy
Volume 22 Number 4 April 1990
Guidelines: Acne vulgaris 679 d) Dermabrasion (scars)
e) Filling materials (scars) j) Surgical repair (scars) 3. Other recommendations a) Follow-up examinationsshouldbe a part of the optimal management of patient's acne, specifically to gauge degree (orlack) of improvement, tolerance to medications, need to augment or attenuate treatment dependingon clinicalresponse, and employment of lesional therapy. Intervals between visits willvary, dependent on, but not limited to, the severityof the problem, the intensity of treatment, and the need for frequent visits for lesional therapy. b) In the early phase of treatment, mare frequent follow-up visits are required than later when the condition has become less active. On average, the interval between visitswillrange from I to 12 weeks, with a median of 4 weeks. B. Miscellaneous Not applicable VI. Supporting evidence See Appendix B (bibliography) VII. Disclaimer Adherence to these guidelines will not ensure successful treatment in every situation. Furthermore, these guidelines should not be deemed inclusive of all proper methods of care or exclusive of other methodsofcare reasonablydirected to obtaining the same results.The ultimate judgment regardingthe proprietyof any specific proceduremust be made by the physician in view of all the circumstances presented by the individual patient.
Appendix A. Guidelinesfor prescribing isotretinoin (Accutane) in the treatment of female acne patientsofchildbearing potential* PATIENT SELECTION In the treatment of females of childbearing potential, Accutane should be used only for patients with severe, disfiguring, cystic acne. Accutane must not be used by females who are pregnant or who may become pregnant while undergoing treatment. Accutane should not be the therapy of firstchoice. It must be demonstrated that the patient is unresponsive to other standard therapies. The patient must be reliable and capable ofunderstandingthe physician's instructions on the use of Accutane, the risks involved, and be willing to comply with these instructions. The patient must be able to complywith effective contraceptive measures (which may include abstinence) for at least one
* Final draft July 1988.Previously published: Pochi et at J AM ACAD DERMAToi. 1988;19:920.
month prior to, throughout, and for at least one month after treatment. In the case of minors, the physical presence of the legal guardian is required when informed consent is obtained.
PHYSICIAN INSTRUCTIONS The physicianhas the responsibility of explainingfully to the patient the expected outcome of fetal exposure to Accutane. This information must be understoodby the patient and her legal guardian, if applicable. A written informed consent form must be signedby the patient and bythe physician or third party witness,and in the case of a minor patient, by the patient's legal guardian. A copy of the signed formwill be given to the patient and, in the case of a minor patient, to her legal guardian. The original consent form should be maintained in the patient's file. If the patient is sexually active,she must be using a highly effective form of contraception. She must be capable of compliance. Gynecologic consultation is suggested for patients who have previously become pregnant while using seemingly adequate contraception. Accutane must not be prescribed unless it isdocumentedin the patient's record that a highly effectiveform of contraception is used (which may include abstinence). A blood pregnancy test must be administered and shown to be negative within two weeksprior to beginning Aceutane therapy. Prescriptions for Accutane mustnot be dispenseduntil the pregnancy test is reported as negative. Therapy should begin in day two or three of the next menstrual cycle. The physician should inform the patient that the Accutane package includes an insert containing information which she should read before she begins using the medication. The physician should encourage the patient to ask him or her questions concerning the risks associated with becoming pregnant while on the medication. Prescriptionsshould be written for no more than two weeks beyonda scheduledfollow-up visit.Visitsto the physicianshould be at least monthly, and a repeat blood pregnancy test should be done monthly. Patients must be advised that the maximum duration of a single treatment course is 20 weeks. Contraceptive use must continue for at least one month after therapy completion. A blood pregnancy test should be done one month after completion of therapy.
Appendix B. Bibliography: Acne vulgaris Pochi PE, CeilleyRI, CoskeyRJ, et al, Guidelines for prescribing isotretinoin (Accutane) in the treatment of female acne patients of childbearing potential. J AM ACAD DERMATOL 1988;19:920. Bigby M, Stern RS. Adverse reactions to isotretinoin. J AM ACAD DERMATOL 1988;18:543-52. Chalker DK, Lesher JL, Smith lE, et al. Efficacy of topical isotretinoin 0.05% gel in acne vulgaris: Results of a multicenter, double-blind investigation. J AM ACAD DERMATOL ]987;17:251-4. Epstein EE, ed. Acne. In: Controversies in dermatology. Philadelphia: WB Saunders, 1984:249-300. Greenwood R, Brummitt L, Burke B, et al, Acne: double-blind clinical and laboratory trial of tetracycline, oestrogen-cyproterone acetate, and combined treatment. Br Med J 1985; 291 :1231-5. Leyden JJ, Shalita AR. Rational therapy for acne vulgaris: an
Journal of the American Academy of Dermatology
680 Drake et al. update on topical treatment. J AM ACAD DERMATOL 1986; 15:907-14. Muh1emann MF, Carter GD, Cream J J, et aI. Oral spironolactone:an effective treatment for acne vulgaris in women. Br J DermatoI1986;1l5:227-32. Plewig G, Kligman AM. Acne, morphogenesisand treatment. Berlin: Springer-Verlag, 1975. Pochi PE. Acne vulgaris. In: Demis DJ, Dobson RL, McGuire JL, eds. Dermatology. Vol. 2, Unit 10-12. Philadelphia: Harper & Row, 1985:1-25. Rothman KF,Pochi PE. Use of oral and topical agents for acne in pregnancy. JAM ACAD DERMATOL 1988;19:431-42. Shalita AR, Cunningham WJ, Leyden 11, et aI. Isotretinoin treatment of acne and related disorders: an update. J AM ACAD DERMATOL 1983;9:629-38. Shalita AR, Leyden JE, Pochi PE, et al. Acne vulgaris. J AM ACAD DERMATOL 1987;16:410-2. Shalita AR, Smith EB. Topical erythromycin versusc1indamycin therapy for acne: multicenter double-blind comparison. Arch Dermatol 1984;120:351-5.
Stern RS, Rosa F, Baum C. Isotretinoin and pregnancy. JAM ACAD DERMATOL 1984;10:851-4. Strauss JS, Rapini RP, Shalita AR, et al, Isotretinoin therapy for acne: results of a multicenter dose-response study. JAM ACAD DERMATOL 1984;10:490-6. TolmanEL. Acneand acneiformdermatoses. In: Moschella SL, Hurley Hl Dermatology. 2nd cd. Philadelphia: WB Saunders, 1985:1306-22. Tucker SB, Tausend R, Cochran R, et al. Comparison of topical clindarnycin phosphate, benzoyl peroxideand combination of twofor the treatment of acne vulgaris. Br J Dermatol 1984;110:487-92. Update on Birth Defects with Isotretinoin. FDA Drug Bull 1984;14:15-6. Webster GF, Leyden Ll, Mechanisms of Propionibacterium acnes: mediated inflammation in acne vulgaris. Semin DermatoI1982;1:299-304.
AMERICAN BOARD OF DERMATOLOGY EXAMINATIONS In 1990 the Certifying Examination of the American Board of Dermatology will be held at the Holiday Inn O'Hare Airport in Rosemont, Illinois on Nov. 4 and 5,1990. The deadline for receipt of applications is May 1, 1990. The Dermatopathology Special Qualification Examination will be held in Tampa, Florida on Nov. 9, 1990. The deadline for receipt of applications is July 1, 1990. The next Examination for Special Qualification in Dermatological ImmunologyI Diagnostic and Laboratory Immunology will be held in Rosemont, Illinois on Nov. 1, 1991. The deadline for receipt of applications is April 1, 1991. For further information about these examinations, please contact: Clarence S. Livingood, MD Executive Director American Board of Dermatology Henry Ford Hospital Detroit, MI 48202
--Lynn A. Drake. MD
This report reflects the best data available at the time the report was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alteration of the conclusions or recommendations set forth in this report.
Guidelines of care for acne vulgaris* Committee on Guidelines ofCare: Lynn A. Drake, MD, chairman, Roger I. Ceilley, MD, Raymond L. Cornelison, MD, William. L. Dobes, MD, William Dorner, MD, Charles W. Lewis, MD, Stuart 1. Salasche, MD, and Maria L. Chanco Turner, MD Task Force on Acne Vulgaris: Peter E. Pochi, MD, chairman, Ralph J. Coskey, MD, Edward A. Krull, MD, Orlando G. Rodman, MD, Maria L. Chanco Turner, MD, and Stephen B. Webster, MD Task Force on Accutane: Peter E. Pochi, MD, chairman, Ralph J. Caskey, MD, Lynn A. Drake, MD, G. Thomas Jansen, MD, Roger I. Ceilley, MD, Orlando G. Rodman, MD, Maria L. Chanco Turner, MD, and Stephen B. Webster, MD Reprintrequests: Lynn A. Drake,MD, Dept.ofDermatology, Bartlett4, Massachusetts General Hospital, Boston, MA 07090. *Approved April 1989.
16/8/18810
676
I. Introduction The American Academy of Dermatology's Committee on Guidelines of Care is developing guidelines of care for our profession. The development of guide-
Volume 22 Number 4 April 1990
lines will promote the continued delivery of quality care and assist those outsideour profession in understanding the complexities and boundaries of care provided by dermatologists. II. Definition Acnevulgarisis a follicular disorder that affectssusceptiblepilosebaceous follicles, primarilyof the face, neck, and upper trunk, and is characterized by both noninflammatory and inflammatory lesions. III. Rationale A. Scope Acne is a disease of high prevalence and affects many persons in their teen age years. Although peak prevalencemay be at age 17,acne may begin as early as age 8 and is not uncommonin the 10- to 12-year-oldage group in which it is often overlooked. Both sexes are affectedequally, but males have, on average,greater degreesof severity. A substantial percentage of adults are affected either as a continuation of their teenage acne Or its first appearance in the third or fourth decade. Most cases of acne subsideand involute spontaneously and completely withina fewyears of their onset, but a small percentageremain active. The disease may cause considerable emotional distress because of its appearance, even when the disease has involuted if scarring has taken place. The psychosocial impact on teenagers may be devastating. B. Issue Acne vulgaris is a conditionof unknown origin; however, multiple factors are known to contribute to its pathogenesis and its aggravation. Althoughthere is no known predictablecure for the disease, numerous therapies are available that can substantially control its activity in most cases. IV. Diagnosticcriteria A. Clinical 1. Patient history To determine appropriatetreatment a patient history should be taken. Information to be gathered may includethe following: a) Duration, to includeprogression to pointof maximal severity b) Location c) Seasonal variation d) Aggravation by stress e) For women (1) Premenstrual flare-up (2) Menstrual history and pregnancy status (3) Increase of androgen-dependent hair (4) Thinning of scalp hair (5) Oral contraceptives and effect on acne (6) Hormone tests
Guidelines: Acne vulgaris 677 (7) Cosmetics and moisturizers: type and frequency fJ Current treatment(s): topical and systemic (1) Of acne (2) Of other diseases g) Past treatment(s): topical and systemic (1) Of acne (2) Of other diseases h) Family history of acne i) Other skin disorders, especially but not limited to: (1) Atopy,personalor familial (becauseof occasional irritation to topical acne preparations) (2) Hidradenitis suppurativa j) Drug allergies k) General health, especially but not limited to: (1) Hepatic disease (2) Renal disease (3) Endocrine 2. Physical examination Establishment of diagnosis should occurafter reviewof the patient history and physicalexamination of the patient for the clinicalcriteria of acne. 3. Lesion type aJ Noninflammatory (I) Open comedones (2) Closed comedones b) Inflammatory (1) Papules (2) Pustules (3) Nodules and/or cysts 4. Location a) Face/neck b) Back c) Anterior chest d) Extremities 5. Gradation a) Mild, moderate, severe b) For each predominant lesion type c) Location 6. Complications a) Scarring type (1) Atrophic (a) Localization (b) Severity (c) Discoloration (2) Hypertrophic (a) Localization (b) Severity (c) Discoloration (3) Keloids (a) Localization (b) Severity
678 Drake et al. (c) Discoloration b) Scarring grade (l ) Definition (2) Location (3) Degree 7. Other associated findings include but are not limited to a) Postinflammatory macular lesions b) Postinflammatory hyperpigmentation and hypopigmentation c) Hirsutism for women d) Alopecia for women e) Asymmetry of distribution of acne jJ Excoriations B. Diagnostic tests There are no diagnostic tests for acne vulgaris. However, in some instances diagnostic tests are used to differentiate and identify acnelike eruptions or to detect the presence of systemic conditions that aggravate acne. Such tests include but are not limited to 1. Bacteria culture (e.g., gram-negative folliculitis) 2. Hormonal assay (e.g., presence of androgen imbalance) 3. Biopsy when necessary to differentiate acne from other diseases C . Inappropriate diagnostic tests" 1. Routine allergy testing 2. Hair analysis D. Exceptions Not applicable E . Evolving diagnostic test Not applicable V. Recommendations A. Treatment Topical treatment alone may be indicated for the following types of acne: mild to moderate comedonal lesions, superficial inflammatory (papular or pustular), and usually nonscarring. In addition, systemic treatment may be indicated for the following types of acne: moderate to severe (scarring or nonscarring) or that in patients with persistent hyperpigmentation. Systemic trea tment may need to be used alone in patients who are intolerant to topical treatment or in whom such treatment has failed. 1. Nonsurgical a) Topical therapy: most commonly used , but not limited to ( 1) Benzoyl peroxide ( 2) Benzoyl peroxide-erythromycin ( 3) Benzoyl peroxide-sulfur ( 4) Topical antibiotics "The tests listed are examples.
Journal of the American Academy of Dermatology
(a) Tetracycline lotion (b) Clindamycin lotion, gel
(c) Erythromycin lotion, swabs, gel (d) Meclocycline cream ( 5) Tretinoin ( 6) Salicylic acid ( 7) a-Hydroxy acid ( 8) Sulfur: including Vleminckx's solution ( 9) Resorcinol (10) Miscellaneous: astringents, soaps, cleansers b) Systemic therapy: most commonly used, but not limited to (1) Antibiotics, oral (a) Tetracycline (b) Erythromycin (c) Minocycline (dJ Trimethoprim-sulfamethoxazole (e) Other (2) Isotretinoin, oral Primary and only approved use is for severe, recalcitrant, cystic acne, refractory to conventional anti-acne measures, including systemic antibiotics. For women of childbearing potential, Appendix A guidelines apply. (3) Hormonal treatments may include the following: (a) Corticosteroids i) Anti-inflanunatory actions: high dose ii) Androgen suppressant action: low dose (b) Sex hormones (for women only) i) Estrogen (oral contraceptive medication) (e) Antiandrogens (4) Other treatments may include the following: (a) Dapsone (b) Diet (in selected cases) (e) Ultraviolet light (d) Superficial exfoliation i) Carbon dioxide-acetone slush ii) Sulfur-resorcinol iii) Chemical 2. Surgical a) Lesional therapy (1) Extraction of comedonal contents (2) Drainage of superficial pustules and cysts (3) Excision of sinus tracts and cysts b) Intralesional corticosteroids c) Cryotherapy
Volume 22 Number 4 April 1990
Guidelines: Acne vulgaris 679 d) Dermabrasion (scars)
e) Filling materials (scars) j) Surgical repair (scars) 3. Other recommendations a) Follow-up examinationsshouldbe a part of the optimal management of patient's acne, specifically to gauge degree (orlack) of improvement, tolerance to medications, need to augment or attenuate treatment dependingon clinicalresponse, and employment of lesional therapy. Intervals between visits willvary, dependent on, but not limited to, the severityof the problem, the intensity of treatment, and the need for frequent visits for lesional therapy. b) In the early phase of treatment, mare frequent follow-up visits are required than later when the condition has become less active. On average, the interval between visitswillrange from I to 12 weeks, with a median of 4 weeks. B. Miscellaneous Not applicable VI. Supporting evidence See Appendix B (bibliography) VII. Disclaimer Adherence to these guidelines will not ensure successful treatment in every situation. Furthermore, these guidelines should not be deemed inclusive of all proper methods of care or exclusive of other methodsofcare reasonablydirected to obtaining the same results.The ultimate judgment regardingthe proprietyof any specific proceduremust be made by the physician in view of all the circumstances presented by the individual patient.
Appendix A. Guidelinesfor prescribing isotretinoin (Accutane) in the treatment of female acne patientsofchildbearing potential* PATIENT SELECTION In the treatment of females of childbearing potential, Accutane should be used only for patients with severe, disfiguring, cystic acne. Accutane must not be used by females who are pregnant or who may become pregnant while undergoing treatment. Accutane should not be the therapy of firstchoice. It must be demonstrated that the patient is unresponsive to other standard therapies. The patient must be reliable and capable ofunderstandingthe physician's instructions on the use of Accutane, the risks involved, and be willing to comply with these instructions. The patient must be able to complywith effective contraceptive measures (which may include abstinence) for at least one
* Final draft July 1988.Previously published: Pochi et at J AM ACAD DERMAToi. 1988;19:920.
month prior to, throughout, and for at least one month after treatment. In the case of minors, the physical presence of the legal guardian is required when informed consent is obtained.
PHYSICIAN INSTRUCTIONS The physicianhas the responsibility of explainingfully to the patient the expected outcome of fetal exposure to Accutane. This information must be understoodby the patient and her legal guardian, if applicable. A written informed consent form must be signedby the patient and bythe physician or third party witness,and in the case of a minor patient, by the patient's legal guardian. A copy of the signed formwill be given to the patient and, in the case of a minor patient, to her legal guardian. The original consent form should be maintained in the patient's file. If the patient is sexually active,she must be using a highly effective form of contraception. She must be capable of compliance. Gynecologic consultation is suggested for patients who have previously become pregnant while using seemingly adequate contraception. Accutane must not be prescribed unless it isdocumentedin the patient's record that a highly effectiveform of contraception is used (which may include abstinence). A blood pregnancy test must be administered and shown to be negative within two weeksprior to beginning Aceutane therapy. Prescriptions for Accutane mustnot be dispenseduntil the pregnancy test is reported as negative. Therapy should begin in day two or three of the next menstrual cycle. The physician should inform the patient that the Accutane package includes an insert containing information which she should read before she begins using the medication. The physician should encourage the patient to ask him or her questions concerning the risks associated with becoming pregnant while on the medication. Prescriptionsshould be written for no more than two weeks beyonda scheduledfollow-up visit.Visitsto the physicianshould be at least monthly, and a repeat blood pregnancy test should be done monthly. Patients must be advised that the maximum duration of a single treatment course is 20 weeks. Contraceptive use must continue for at least one month after therapy completion. A blood pregnancy test should be done one month after completion of therapy.
Appendix B. Bibliography: Acne vulgaris Pochi PE, CeilleyRI, CoskeyRJ, et al, Guidelines for prescribing isotretinoin (Accutane) in the treatment of female acne patients of childbearing potential. J AM ACAD DERMATOL 1988;19:920. Bigby M, Stern RS. Adverse reactions to isotretinoin. J AM ACAD DERMATOL 1988;18:543-52. Chalker DK, Lesher JL, Smith lE, et al. Efficacy of topical isotretinoin 0.05% gel in acne vulgaris: Results of a multicenter, double-blind investigation. J AM ACAD DERMATOL ]987;17:251-4. Epstein EE, ed. Acne. In: Controversies in dermatology. Philadelphia: WB Saunders, 1984:249-300. Greenwood R, Brummitt L, Burke B, et al, Acne: double-blind clinical and laboratory trial of tetracycline, oestrogen-cyproterone acetate, and combined treatment. Br Med J 1985; 291 :1231-5. Leyden JJ, Shalita AR. Rational therapy for acne vulgaris: an
Journal of the American Academy of Dermatology
680 Drake et al. update on topical treatment. J AM ACAD DERMATOL 1986; 15:907-14. Muh1emann MF, Carter GD, Cream J J, et aI. Oral spironolactone:an effective treatment for acne vulgaris in women. Br J DermatoI1986;1l5:227-32. Plewig G, Kligman AM. Acne, morphogenesisand treatment. Berlin: Springer-Verlag, 1975. Pochi PE. Acne vulgaris. In: Demis DJ, Dobson RL, McGuire JL, eds. Dermatology. Vol. 2, Unit 10-12. Philadelphia: Harper & Row, 1985:1-25. Rothman KF,Pochi PE. Use of oral and topical agents for acne in pregnancy. JAM ACAD DERMATOL 1988;19:431-42. Shalita AR, Cunningham WJ, Leyden 11, et aI. Isotretinoin treatment of acne and related disorders: an update. J AM ACAD DERMATOL 1983;9:629-38. Shalita AR, Leyden JE, Pochi PE, et al. Acne vulgaris. J AM ACAD DERMATOL 1987;16:410-2. Shalita AR, Smith EB. Topical erythromycin versusc1indamycin therapy for acne: multicenter double-blind comparison. Arch Dermatol 1984;120:351-5.
Stern RS, Rosa F, Baum C. Isotretinoin and pregnancy. JAM ACAD DERMATOL 1984;10:851-4. Strauss JS, Rapini RP, Shalita AR, et al, Isotretinoin therapy for acne: results of a multicenter dose-response study. JAM ACAD DERMATOL 1984;10:490-6. TolmanEL. Acneand acneiformdermatoses. In: Moschella SL, Hurley Hl Dermatology. 2nd cd. Philadelphia: WB Saunders, 1985:1306-22. Tucker SB, Tausend R, Cochran R, et al. Comparison of topical clindarnycin phosphate, benzoyl peroxideand combination of twofor the treatment of acne vulgaris. Br J Dermatol 1984;110:487-92. Update on Birth Defects with Isotretinoin. FDA Drug Bull 1984;14:15-6. Webster GF, Leyden Ll, Mechanisms of Propionibacterium acnes: mediated inflammation in acne vulgaris. Semin DermatoI1982;1:299-304.
AMERICAN BOARD OF DERMATOLOGY EXAMINATIONS In 1990 the Certifying Examination of the American Board of Dermatology will be held at the Holiday Inn O'Hare Airport in Rosemont, Illinois on Nov. 4 and 5,1990. The deadline for receipt of applications is May 1, 1990. The Dermatopathology Special Qualification Examination will be held in Tampa, Florida on Nov. 9, 1990. The deadline for receipt of applications is July 1, 1990. The next Examination for Special Qualification in Dermatological ImmunologyI Diagnostic and Laboratory Immunology will be held in Rosemont, Illinois on Nov. 1, 1991. The deadline for receipt of applications is April 1, 1991. For further information about these examinations, please contact: Clarence S. Livingood, MD Executive Director American Board of Dermatology Henry Ford Hospital Detroit, MI 48202