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Adapalene 0.1% gel combinations for the treatment of moderate to moderately-severe acne patients
P111
P113
Adapalene 0.1% gel combinations for the treatment of moderate to moderately-severe acne patients James Campbell, MD, MS, Dartmouth Medical School, Dover, NH, United States; Luz Colon, MS, Galderma Laboratories, L.P., Fort Worth, TX, United States; Lori Johnson, MD, PhD, Galderma Laboratories, L.P., Fort Worth, TX, United States; Ronald Gottschalk, MD, Galderma Laboratories, L.P., Fort Worth, TX, United States Acne vulgaris is often cyclical and can be difficult to treat. Combination approaches are increasingly used as the initial treatment strategy. A study was conducted to evaluate the benefit of an initial combination treatment approach compared to adding an additional drug to existing treatment. Patients were prescribed either an initial treatment regimen containing adapalene 0.1% gel or, if they were already being treated, had adapalene 0.1% gel added on to their current treatment. Efficacy and safety assessments were made at baseline, week 6, and week 12. A total of 1722 patients were enrolled with approximately 75% of them being treated with an initial combination approach. Patients from both treatment groups responded well to adapalene-containing combination regimens with slightly more patients (57%) on initial combinations achieving treatment success (clear or almost clear) compared to those who had adapalene added on to existing regimens.
Safety and efficacy of adapalene 0.1% gel when used in combination with benzoyl peroxideeantibiotic topical combination agents Jonathan Weiss, MD, Gwinnett Dermatology, PC, Snellville, GA, United States; Luz Colon, MS, Galderma Laboratories, L.P., Fort Worth, TX, United States; Ronald Gottschalk, MD, Galderma Laboratories, L.P., Fort Worth, TX, United States; Lori Johnson, PhD, Galderma Laboratories, L.P., Fort Worth, TX, United States Combination therapy involving a topical retinoid represents one of the most common treatment approaches for acne patients. Adapalene is a topical retinoid that is frequently chosen for combination with other agents because of its milder tolerability profile. Benzoyl peroxideeantibiotic topical combination agents represent a significant proportion of these combination strategies. A large trial was conducted to evaluate combination therapy involving adapalene in patients with moderate to moderately-severe acne. A total of 315 were treated with the combination of adapalene 0.1% gel and a benzoyl peroxide-antibiotic combination agent for a period of 12 weeks. Assessments were made at baseline, week 6, and week 12. Approximately 60% of the patients achieved treatment success (clear or almost clear) by week 12. Tolerability problems were rare and typically mild in severity. These results support the combination use of adapalene and benzoyl peroxideeantibiotic combination agents.
Study and poster support provided by Galderma Laboratories, L.P. Study and poster support provided by Galderma Laboratories, L.P.
P114
Although acne has traditionally been labeled a condition of adolescence, many adults also suffer from this disease and are subject to many of the psychological and social ramifications usually accompanying acne. Young adult females are particularly sensitive to these psychological effects. Many physicians feel that they get better results when treating the young adult population compared to the adolescents and attribute this to a likelihood of better compliance from the adult population. A comparative analysis was conducted among a total of 1092 patients who were prescribed adapalene 0.1% gelecontaining combination regimens and treated for a 12-week period. Efficacy and safety assessments were made at baseline, week 6, and week 12. Among the 1092 patients that made up the ITT population, 481 were adolescent (mean age, 15.5 yrs) and 611 were adults (mean age, 29.9 yrs). There were no significant differences between the groups in baseline severity. Surprisingly, compliance analyses revealed little difference between the groups at both week 6 and at week 12. For adolescents, the compliance rate at week 6 was 92.3% and at week 12 was 87.3%. For adults, the compliance rate at week 6 was 96.2% and at week 12 was 88.5%. Investigator global assessments found that the adult group had significantly more patients who achieved treatment success (clear, almost clear, or marked improvement) than did the adolescent group (64.8% vs. 50.3%; P \.0001). These results confirm the anecdotal observations regarding better treatment results for adults than adolescents, but also suggest that factors other than treatment compliance may be contributing to the phenomenon.
The combination of metronidazole gel and sodium sulfacetamide cleanser is efficacious and well-tolerated by rosacea patients Serena Mraz, MD, Solano Dermatology Associates, Vallejo, CA, United States; Karl Beutner, MD, Anacor Pharmaceuticals, Palo Alto, CA, United States Rosacea is a skin condition characterized by unsightly redness on the face often accompanied by acne-like papules and pustules. Symptom flares are most often triggered by spicy foods, sun exposure, or irritating skin products. Accordingly, the irritation potential of any topical treatment prescribed for rosacea patients should be considered. Dry skin can also be more susceptible to irritation. Metronidazole has been widely used as a primary topical treatment for rosacea for several years. It is available in two concentrations in a variety of formulations. Sodium sulfacetamide and sulfur (SSS) agents are gaining popularity as a complementary treatment because many patients are inadequately controlled with monotherapy. Despite efficacy, the hallmark odor that is associated with SSS agents is unpleasant and therefore having a wash-off product is preferable to a leave-on product. A singlecenter, open-label study was conducted to assess the patient acceptability of treatment with twice-daily metronidazole 0.75% gel applied immediately after twicedaily cleansing with 10% sodium sulfacetamide and 5% sulfur cleanser (both products from Galderma Laboratories, L.P.). The treatment period was for 4 weeks with evaluations at baseline and weeks 2 and 4. Evaluations included inflammatory lesion counts, erythema severity scores, global severity scores, and patient and investigator assessments of tolerability. Adverse events were captured at all postbaseline visits. A total of 34 patients with papuloerythrodermic rosacea were enrolled and 31 completed the study. Three patients reduced the cleansing regimen to once-daily for local tolerance reasons. After 4 weeks of treatment, 24 patients (77%) had a reduction in inflammatory lesion counts. The mean global severity scores improved over the course of the study as well from 1.6 at baseline to 1.1 after 4 weeks of treatment. Patient-assessed tolerability was good with average irritation scores at 4 weeks being between none and mild for all parameters tested. A total of 11 adverse events were reported, 1 of which was considered possibly related to the study medication. These results support the combination of SSS cleaners with topical metronidazole for the treatment of rosacea.
Study and poster support provided by Galderma Laboratories, L.P.
Study and poster support provided by Galderma Laboratories, L.P.
P112 Do adults respond better to acne treatment than adolescents? Linda Stein Gold, MD, Henry Ford Hospital, Dermatology Clinical Research, West Bloomfield, MI, United States; Luz Colon, MS, Galderma Laboratories, L.P., Fort Worth, TX, United States; Lori Johnson, MD, PhD, Galderma Laboratories, L.P., Fort Worth, TX, United States
AB14
J AM ACAD DERMATOL
FEBRUARY 2008
P113
Adapalene 0.1% gel combinations for the treatment of moderate to moderately-severe acne patients James Campbell, MD, MS, Dartmouth Medical School, Dover, NH, United States; Luz Colon, MS, Galderma Laboratories, L.P., Fort Worth, TX, United States; Lori Johnson, MD, PhD, Galderma Laboratories, L.P., Fort Worth, TX, United States; Ronald Gottschalk, MD, Galderma Laboratories, L.P., Fort Worth, TX, United States Acne vulgaris is often cyclical and can be difficult to treat. Combination approaches are increasingly used as the initial treatment strategy. A study was conducted to evaluate the benefit of an initial combination treatment approach compared to adding an additional drug to existing treatment. Patients were prescribed either an initial treatment regimen containing adapalene 0.1% gel or, if they were already being treated, had adapalene 0.1% gel added on to their current treatment. Efficacy and safety assessments were made at baseline, week 6, and week 12. A total of 1722 patients were enrolled with approximately 75% of them being treated with an initial combination approach. Patients from both treatment groups responded well to adapalene-containing combination regimens with slightly more patients (57%) on initial combinations achieving treatment success (clear or almost clear) compared to those who had adapalene added on to existing regimens.
Safety and efficacy of adapalene 0.1% gel when used in combination with benzoyl peroxideeantibiotic topical combination agents Jonathan Weiss, MD, Gwinnett Dermatology, PC, Snellville, GA, United States; Luz Colon, MS, Galderma Laboratories, L.P., Fort Worth, TX, United States; Ronald Gottschalk, MD, Galderma Laboratories, L.P., Fort Worth, TX, United States; Lori Johnson, PhD, Galderma Laboratories, L.P., Fort Worth, TX, United States Combination therapy involving a topical retinoid represents one of the most common treatment approaches for acne patients. Adapalene is a topical retinoid that is frequently chosen for combination with other agents because of its milder tolerability profile. Benzoyl peroxideeantibiotic topical combination agents represent a significant proportion of these combination strategies. A large trial was conducted to evaluate combination therapy involving adapalene in patients with moderate to moderately-severe acne. A total of 315 were treated with the combination of adapalene 0.1% gel and a benzoyl peroxide-antibiotic combination agent for a period of 12 weeks. Assessments were made at baseline, week 6, and week 12. Approximately 60% of the patients achieved treatment success (clear or almost clear) by week 12. Tolerability problems were rare and typically mild in severity. These results support the combination use of adapalene and benzoyl peroxideeantibiotic combination agents.
Study and poster support provided by Galderma Laboratories, L.P. Study and poster support provided by Galderma Laboratories, L.P.
P114
Although acne has traditionally been labeled a condition of adolescence, many adults also suffer from this disease and are subject to many of the psychological and social ramifications usually accompanying acne. Young adult females are particularly sensitive to these psychological effects. Many physicians feel that they get better results when treating the young adult population compared to the adolescents and attribute this to a likelihood of better compliance from the adult population. A comparative analysis was conducted among a total of 1092 patients who were prescribed adapalene 0.1% gelecontaining combination regimens and treated for a 12-week period. Efficacy and safety assessments were made at baseline, week 6, and week 12. Among the 1092 patients that made up the ITT population, 481 were adolescent (mean age, 15.5 yrs) and 611 were adults (mean age, 29.9 yrs). There were no significant differences between the groups in baseline severity. Surprisingly, compliance analyses revealed little difference between the groups at both week 6 and at week 12. For adolescents, the compliance rate at week 6 was 92.3% and at week 12 was 87.3%. For adults, the compliance rate at week 6 was 96.2% and at week 12 was 88.5%. Investigator global assessments found that the adult group had significantly more patients who achieved treatment success (clear, almost clear, or marked improvement) than did the adolescent group (64.8% vs. 50.3%; P \.0001). These results confirm the anecdotal observations regarding better treatment results for adults than adolescents, but also suggest that factors other than treatment compliance may be contributing to the phenomenon.
The combination of metronidazole gel and sodium sulfacetamide cleanser is efficacious and well-tolerated by rosacea patients Serena Mraz, MD, Solano Dermatology Associates, Vallejo, CA, United States; Karl Beutner, MD, Anacor Pharmaceuticals, Palo Alto, CA, United States Rosacea is a skin condition characterized by unsightly redness on the face often accompanied by acne-like papules and pustules. Symptom flares are most often triggered by spicy foods, sun exposure, or irritating skin products. Accordingly, the irritation potential of any topical treatment prescribed for rosacea patients should be considered. Dry skin can also be more susceptible to irritation. Metronidazole has been widely used as a primary topical treatment for rosacea for several years. It is available in two concentrations in a variety of formulations. Sodium sulfacetamide and sulfur (SSS) agents are gaining popularity as a complementary treatment because many patients are inadequately controlled with monotherapy. Despite efficacy, the hallmark odor that is associated with SSS agents is unpleasant and therefore having a wash-off product is preferable to a leave-on product. A singlecenter, open-label study was conducted to assess the patient acceptability of treatment with twice-daily metronidazole 0.75% gel applied immediately after twicedaily cleansing with 10% sodium sulfacetamide and 5% sulfur cleanser (both products from Galderma Laboratories, L.P.). The treatment period was for 4 weeks with evaluations at baseline and weeks 2 and 4. Evaluations included inflammatory lesion counts, erythema severity scores, global severity scores, and patient and investigator assessments of tolerability. Adverse events were captured at all postbaseline visits. A total of 34 patients with papuloerythrodermic rosacea were enrolled and 31 completed the study. Three patients reduced the cleansing regimen to once-daily for local tolerance reasons. After 4 weeks of treatment, 24 patients (77%) had a reduction in inflammatory lesion counts. The mean global severity scores improved over the course of the study as well from 1.6 at baseline to 1.1 after 4 weeks of treatment. Patient-assessed tolerability was good with average irritation scores at 4 weeks being between none and mild for all parameters tested. A total of 11 adverse events were reported, 1 of which was considered possibly related to the study medication. These results support the combination of SSS cleaners with topical metronidazole for the treatment of rosacea.
Study and poster support provided by Galderma Laboratories, L.P.
Study and poster support provided by Galderma Laboratories, L.P.
P112 Do adults respond better to acne treatment than adolescents? Linda Stein Gold, MD, Henry Ford Hospital, Dermatology Clinical Research, West Bloomfield, MI, United States; Luz Colon, MS, Galderma Laboratories, L.P., Fort Worth, TX, United States; Lori Johnson, MD, PhD, Galderma Laboratories, L.P., Fort Worth, TX, United States
AB14
J AM ACAD DERMATOL
FEBRUARY 2008