dry skin hormone-containing cosmetics •••
and chapping aids
by Robert l. Day
D
ry skin is probably the only affliction, aside from the common cold, which touches everyone in the United States at least once a year. Since most persons pay little attention to it, it is probably the most ignored skin condition and this is unfortunate because it is probably one of the most amenable "diseases" to treatment. This condition arises in the young and old, male and female, chronically in some and cyclically in others. The complaints usually presented by those who do care to treat it are numerous-"I have rough patches of itchy, dry skin; my lips are chapped; my hands are not soft." Occasionally, this condition is complicated by eczema or "scratcher's disease." Unfortunately persons with these complaints usually present themselves to a clerk or "cosmetician" who usually has no true conception of what causes the problem. It has always been the
author's contention that the pharmacist should be called for any "complaint" regardless of how trivial. A clerk can and should assist clients in preselected items. He should not make recommendations. If he does, he assumes one of the professional responsibilities of the pharmacist and this assumption is not in the best interest of the public or of the profession. Almost every pharmacy is overendowed with a wide variety of sweet or menthol-smelling lotions, creams, sticks and bath oils, each of which makes labeled claims of superiority in the abatement of dry skin. Obviously, they are not all equal. Obviously, some are ineffective. How does one evaluate these products? dry skin
Before a product can be evaluated, some knowledge of the causes of dry skin
Robert L. Day is a community pharmacist in Daly City, California and lecturer in pharmacy at the University of California school of pharmacy. A graduate of the University-receiving his BS in 1958 and his PharmD in 1959-he was appointed assistant clinical professor of pharmacy at the University of California in 1962 and chosen for his current position in July of this year. Past president of Peninsula Pharmaceutical Society, he is a member of APhA, American College of Apothecaries and the California and San Mateo County pharmaceutical associations.
is mandatory. The term "skin" is a gross anatomical term, referring to a multitude of histo10gica11ayers extending from the dermis to the epidermis. The outermost layer, the stratum corneum is composed primarily of keratin, a dead, unnucleated sheath. This layer is hygroscopic and must contain at least 10 percent moisture l to remain soft and flexible. When moisture falls below this concentration, the keratin becomes progressively less flexible, rough, brittle and eventually cracked. This is the condition which the public recognizes as dry skin. The keratin receives a small portion of its moisture from the sweat glands and primarily from the underlying tissues. This is a slow diffusion process since the moisture must travel to the keratin across a physica11ayer called the barrier. One of the barrier's primary functions is the conservation of water. Without the barrier, our body fluids would evaporate in several hours; it is extremely miserly in the amounts of water which it will allow to pass through. The keratin, although hygroscopic, would lose its small amount of moisture rapidly were it not for a layer of sebum which flows over the body and coats the skin. Sebum is a complex, sticky, oleaginous material which, although not occlusive, retards moisture loss from the keratin. Under normal circumstances, the sebum retards enough moisture loss to maintain the keratin in its flexible state. There are several environmental factors which can remove moisture from the keratin (in spite of the sebum) at a faster rate than it can be replaced from be10w-(1) air currents, giving birth to the "wind-burn" phenomenon, (2) high temperatures and (3) the greatest offender, low humidity. Consider a typ(continued on page 652)
650
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
chapping products
dry skin cosmetics
(continued from page 650)
ical sportsman, the skier. Since humidity falls with temperature and altitude, he skis in a medium of dry air which will supplement its thirst by extracting water from him. Secondly, he whizzes down the slopes and submits himself to considerable wind currents. He has doubly satisfied the requirements for dry skin and may show it in his reddened (not necessarily sunburned) face. The average person, however, usually experiences dry skin during the cold snaps of the year when the humidity falls. The dry skin problem is compounded by the fact that people tend to stay indoors during these times of the year and bask in an even less humid atmosphere, since air which is heated and expanded falls in relative humidity. There are, of course, other potential sources of dry skin, such as occupational hazards. Persons who constantly expose their hands or parts of their bodies to solvents (painters, service station attendants) are continually removing the protective coat of sebum. In many cases the skin has not replaced the sebum before the next exposure. Another such occupational hazard is the not uncommon dilemma of the housewife-dishwater hands. Since she constantly has her hands in dishwater containing household detergent products, she automatically may attribute any hand skin problem to the simple act of washing dishes. True, dish cleaning products contain detergents and alkalies that may defat the skin at approximately the same rate as the dishes. It is also possible that this constant exposure may cause some dry skin problems. However, the phenomenon referred to as "dishwater hands" may not necessarily be related to dishwater. Several authors have suggested that this well-known skin problem actually may have arisen as a response to the myriad of other chemicals to which the housewife is exposed on a daily basis. Suskind 2 suggests this and Kligman (as reported by Kalish 3) statesIn fact, continued exposure to low concentrations (of household detergents) seems to develop protective hardening of the skin. Other dermatitis is improved rather than made worse by exposure to detergents.
Further resolution of this condition is eagerly awaited. Whatever the cause of dry skin (environmental or occupational), the skin becomes harsh, rough, red and cracked. Skin which is cracked can never be rejoined. However, it can be made soft and flexible again.
oleaginous materials If one can coat the skin with a hydrophobic material which is more efficient 652
type of product
general description and comments
non-emulsified products
Easily distinguishable because they are clear or translucent products_ Usually solidified petrolatum or mineral oil solutions. May contain lanolin for added consumer impact. This general type (including plain mineral oil, etc.) is the most efficient class of dry skin products_
chapped lip preparations
Usually contain stiffened petrolatum or mineral oil. Usually non-emulsified_ Some contain unproven "healing agents." All probably equally effective if applied by lip-licking consumer many times during the day.
night creams, cold creams, etc_
All contain high concentrations of oleaginous materials and varying amounts of exotic ingredients (mink oil, persic oil, etc.), all of which resolve simply into oleaginous materials. No proven therapeutic advantage over simple oleaginous materials; mineral oil for example. No proven advantage of one over the other (aside from price).
day creams, moisturizing creams, hand and body lotions
Close relatives of night creams. Usually contain a smaller percentage of oleaginous materials. Most offer cosmetic advantage of "vanishing" when rubbed in. Most are water continuous emulsions. Less effective than simple oleaginous materials_
bath oils
Contain mineral oil or vegetable oil, alone or in combination with fatty acid ester. Contain varying amounts of surfactants to cause oil to spread on surface of bath or emulsify into small particles. Aside from price, little proven advantage of one emulsifiable type over the other. Surface spreading approach seems most sensible.
hormone creams and lotions
All contain maximum permissible estrogen (10,000 units per ounce). All have doubtful activity" in any age group.
pregnenolone _5% cream
Claimed not to be hormone. However, minor effect elicited is not dissimilar to estrogen activity." Product is not lastingly effective.
vitamin creams and lotions
A symbol of the times. Water soluble vitamins (8 series, protein hydrolysates, etc.) have no proven topical activity. Vitamin A preparations usually contain 50,000 units per ounce. Again, have no proven effect in dry skin conditions.
than sebum, the keratin will have a chance to hydrate again. Steigleder 4 indicated indirectly that petrolatum is probably the most efficient readily available material around. Zinc oxide paste came off second best, followed by petrolatum-containing silicones, which is interesting when one considers that silicones are promoted as increasing water impermeability. These materials spread well, form a continuous layer and retard moisture loss. One could go further to suggest that mineral oil, vegetable oil and even shortening would work fairly well. There are examples of petrolatum or mineral oil preparations on the market, some of which are stiffened by beeswax or fatty materials (for example, the lip pomades) . However, petrolatum remains as probably the most efficient. It is a bit greasy and some consideration must be given to the client (usually a female). In her mind's eye, the cure may be worse than the disease.
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
oil continuous emulsions Next in line in degree of efficiency are the oil continuous emulsions. These preparations contain emulsifiers which entrap water in the form of tiny droplets in a sea of oil. By necessity they contain 50 percent oil (or less) and spread on the skin to form a continuous layer. However, they are not as hydrophobic as a non-emulsified oil, since moisture from the skin can emulsify into the oil phase and eventually work to the surface. Unfortunately, these types of emulsions, although fairly efficient, are not very popular. The patient usually tries to rub too much on and perceives a greasy "skin-feel." If suitably small amounts are used, this effect is minimized.
water continuous emulsions Generally speaking, the water continuous emulsions, although the most cosmetically acceptable, are the least efficient in retarding moisture loss. In
this type of emulsion the oleaginous materials are suspended in water. These come in a wide variety of viscosities and varying concentrations of oil content (from approximately 10-40 percent). They are not as effective for severalreasons-1. On the skin they form discontin-
uous layers, or "plaques" through which moisture can leak. 2. They usually contain humectants such as glycerin which in low humidity situations will actually draw water from the already thirsty keratin. 3. The emulsifiers present can emulsify the continuous coat of sebum, decreasing its effectiveness. One reason for the popularity of the water continuous emulsions is that they are not greasy (most hand lotions, body lotions, vanishing creams are water continuous). Another is that most of these preparations contain fatty acids, alcohols or esters. These materials will fill in the rough hills and valleys of the dry skin condition. The overall effect is that hands and skin will slip over each other and feel "silky" (a nondescript cosmetic term). However, moisture loss may only be slightly impeded and the dry skin condition may be progressing.
bath oils An interesting approach is the use of bath oils. Usually these preparations contain mineral oil (alone or in combination with isopropyl myristate or some fatty ester)or a vegetable oil, such as cottonseed oil; most also contain an oil-inwater favoring surfactant. The patient is instructed to add a capful or two to a tub of water and to climb in, rapidly rehydrating the skin. Theoretically he adsorbs a portion of the oil in suspension around him. Although there are reports of their therapeutic usefulness in a wide variety of diseases,5- 8 these are either poorly controlled or uncontrolled studies. It is difficult to imagine why these suspended oil particles should have an affinity for the skin, but Taylor 9 has determined that up to seven grams of these bath oils are adsorbed when a patient soaks for 20 minutes and 25 grams (approximately one ounce) is added to a 30-gallon tub . Several questions remain unanswered-1. Is this enough oil to appreciably
retard moisture loss? 2. Is the oil on the skin in a continuous or discontinuous layer? 3. How long do these preparations remain on the skin? Haensch lO states that two-thirds of the oils are gone after three hours, although he neglects to disclose his technic for determining this. He also advocates the use of 60 milliliters for optimum
effect. If he is correct, the addition of a capful or two to a tub of water does appear to be a bit optimistic. A recent approachll suggests the incorporation of a surfactant (Arlatone T) to act not as an emulsifying agent, but as a spreading agent. Mineral oil and other oils do not spread well on a surface of water. The incorporation of one percent of the above surfactant permits the oil to spread instantly to a thin film on the surface of the bath. This appears to be an extremely sensible approach since as the patient leaves the tub, he will take with him a film of oil which will coat every surface of the body. At present, there is no product on the market containing Arlatone T; however a rapid perusal of the bath oils section of the pharmacy will reveal at least one product of the "spreading" type, another which is dabbed on with a sponge and another which is sprayed on in aerosol form-which raises the ugly question of possible lipoid pneumonia from inhalation either by the adult or the experimenting infant.
vitamin A topicals Several products in the pharmacy contain vitamin A and infer either directly or indirectly that they are topically effective in dry skin states. There are various papers in the literature on vitamin A, most of which indicate the oral route. If any effect were to be elicited from a topical application, it would have to penetrate at least to the layer where the cells are being formed. Since vitamin A is extremely oil soluble, the barrier will not permit it to pass in any reasonable concentration to this depth. Although there is fairly good evidence to indicate that vitamin A can penetrate normal intact animal skin I2 ,13 and Mandelbaum and Schlesinger I4 indicate a systemic effect after external application to humans, Flesh 15 reports the application of 4,600,000 units to the backs of two human subjects with no detectable plasma level. Blank 16 suggests-Very little evidence has been found to show that the use of cosmetics containing vitamin A is any more beneficial for controlling symptoms of dryness than are simple emollient creams not containing vitamin A.
hormone and related creams Hormone creams seldom suggest on the label the age group for which they are designed. Young and old alike may rub them in gaily, much to the cosmetic industry's delight. Occasionally, however, there is a reference made to dry skin, senile skin or wrinkling. During aging, the skin undergoes many changes. Constant exposure to sunlight alters the collagen or supporting tissues. This effect is cumulative. The skin sags and
hangs in folds or wrinkles. Also due to hormonal imbalance and other factors, the skin becomes thinner and sebacious output is less. Most elderly persons complain that their skin is "dry." There is almost universal agreementI 6 - IS that estrogens in cosmetics (limited by FDA to 10,000 units per ounce) do not have any effect upon the nature of dry or aging skin. Most certainly their use by young women is ridiculous. A recent entry into the wrinkling area, a cream containing onehalf percent Pregnenolone Acetate (Externa 27),19,20 is reported to be effective in removing wrinkles. Pregnenolone is the chemical and biological precursor to progesterone, although it is devoid of estrogenic or progestational activity. Careful consideration of these reports reveals that although there is some "plumping" of the skin and smoothing out of tiny "crow's feet," the deep wrinkles of the skin are unaffected. Young women showed little effect, if any, and when the cream was discontinued in the elderly, the wrinkles reappeared. Recently a new material has appeared in some of the advertisements in cosmetic journals which are directed to cosmetic manufacturers. This is placenta extract gel. It is exactly what it sounds like, a placental extract. It contains no hormones, but is composed of amino acids, vitamins and whatnot. At least one person 2I feels that it is helpful in a senile skin condition. In this uncontrolled study, beneficial effects were noted after the gel had been applied for several minutes, washed off and an emollient cream applied. One has sufficient reason to wonder if the effect of the emollient was mistaken for the effect of the placenta gel.
glycerin and rosewater and glycerin products As suggested before, the use of glycerin as a "moisturizing agent" is doubtful. When the humidity is low, it will extract moisture from the skin. It will only extract moisture from the atmosphere (making it available for the skin) when the humidity is high. Unfortunately, this product is not usually used during times of high humidity since it is virtually impossible to have a dry skin problem when the relative humidity is in excess of 60 percent.l
emulsion determination If, then, oils are the most effective hydrophobic materials, and oil continuous emulsions are second most effective and water continuous emulsions place third, it would be extremely valuable for the pharmacist to be able to determine emulsion types. This information is not printed on any cosmetic label, so, therefore, the pharmacist can and must Vol. NS6, No. 12, December 1966
653
determine experimentally the types of emulsions represented in the products he will recommend. filter paper method (for relatively nonviscous emulsions)
Several drops of the emulsion are placed in the center of a filter paper. After several minutes a zone will appear around the drops and will slowly expand. If the filter paper has been weakened, that is to say, if a stirring rod will easily punch a hole through this zone, the emulsion is water continuous. Oil continuous emulsions will also create zones but the paper is not weakened. drop dilution method (for relatively nonviscous emulsions)
A drop or two of the emulsion is added to a beaker of water and stirred with a spatula. If the emulsion disperses and forms a milky solution, it is probably water continuous. If it does not disperse but merely breaks into droplets which float or sink, it is oil continuous. hot water dilution method (for viscous emulsions)
Some emulsions are too viscous for the previous test to give conclusive evidence. To a beaker of nearly boiling water, a drop or small amount of the emulsion is added. If, after a few seconds (the emulsion must warm up), it literally explodes by rapidly spreading over the surface of the water and forms a milky solution when stirred gently, it is water continuous. If it does not spread rapidly or does not disperse easily, it is oil continuous.
conclusion
Health and Disease," J. Southern Med. Assn., 55, 996(Oct. 1962).
Occasionally confusing terminology appears on the labels of cosmetic products. For example, what is a "rich emollient?" Does this infer expense or potency? What is a "texturizing" cream or "dewy freshness?" Semanticists will tell you that these are advertising claims which carry considerable impact. Is not the word "moisturizer" possibly a misnomer? The noun "moisturizer" like "dynamiter" is an active term inferring positive ability to do something, to make something more wet. Occlusive bases, however, are passive; they merely lay upon the skin while skin processes do the "moisturizing." One of the more blatant terms is "penetrating ingredients." A skin scientist will tell you that a penetrating ingredient is one which is percutaneously absorbed, one which passes through the skin. The director of cosmetic research for a leading cosmetic firm admitted to a group of dermatologists 22 that no cosmetic product penetrates the skin and that the term "penetrates" merely means that it rubs in well and "leaves a dry, silky, velvety or even dewy (moist) feel to the skin." Furthermore, he felt that the public knew that it meant just this. One cannot help but wonder if he does not give the public credit for an inordinate amount of sophistication in deciphering cosmetic claims. One further wonders if the labeled claim of "vanishes" or "rubs in well" wouldn't tell the story a bit more succinctly. •
3. 4. 5. 6. 7. 8. 9.
10. 11.
12. 13.
14. 15. 16. 17. 18. 19. 20.
21.
references 1. 2.
Blank, I., "Factors which Influence the Water Content of the Stratum Corneum," J. Invest. Derm., 18,433(1952). Suskind, R., "Cutaneous Cleansing in
Kalish,
}.,
"Cosmetic
Compounding,"
'Drug and Cosmetic Ind., 116(April 1966).
22.
Steigleder, Raab, "Skin Protection Afforded by Ointments," J. Invest. Derm., 38, 3, 129(March 1962). Borata, A., Grin ell, R.N., "Experimental and Clinical Observations on Dry Skin," J. Amer. Geriatric Soc., 10, 413(May 1962). Spoor, H.}., "Management and Maintenance of Natural Skin Oil," N.Y. State J. Med., 58, 3292(1958). Weissberg, G., "Efficacy of Bath Oil in Management of Dry Skin," Clin. Med., 7, 1161(1960). Lieberman, W., "Treatment of Peri-Anal Dermatitis," Amer. J. Protology, 12, 374 (1961). Taylor, E., "Cutaneous Adsorption of Bath Oils," Arch. Derm., 87, 369(March 1963). Haensch, R., Amer. Perfumer and Cosmetics 79, 29(July 1964). Becher, P., Courtney, D.L., "A PhysicoChemical Approach to a Floating Bath Oil," Amer. Perfumer and Cosmetics, 80, 25(Nov. 1965). Bern, H., et aI, "Influence of Vitamin A on Epidermis," Am. J. Anat., 96, 419(May 1955). Montagna, W., "Penetration and Local Effect of Vitamin A on Skin of Guinea Pig," Proc. Soc. BioI. and Med., 86, 668(Aug. 1954). Mandelbaum, J., and Schlesinger, L., "Absorption of Vitamin A through Human Skin," Dermat. and Syph., 46, 431(Sept. 1942). Flesh, P., "Inhibition of Keratin Formation with Unsaturated Compounds," J. Invest. Derm., 19, 353(1952). Blank,!., "Action of Emollient Creams and their Additives," JAMA, 164, 414(May 25, 1957). Strauss, }., "Hormones in Cosmetics," JAMA 186, 759(Nov. 1963). Behrman, H.T., "Hormone Creams and Facial Skin," JAMA, ISS, 119(1954). Silson, }., "'Pregnenolone Acetate' Dermatologically Active Steroid," J. Soc. Cosmetic Chem., 13, 129 (April 1962). Sternberg, T.H., Levan, P., Wright, E.T., "Hydrating Effects of Pregnenolone Acetate on Human Skin," Curro Ther. Research, 3, 469(Nov. 1961). Lubowe, 1., "Effect of Placenta Gel Extract on Aging Skin (Non-Estrogenic)," J. Amer. Geriat. Soc., 11, 914(Sept. 1963). Goldemberg, R.L., "Cosmetic Formulating, Possible Applications in Dermatologic Practice," Arch. Derm. (Chic), 88, 627(Nov. 1963).
selection committee for •••
military section literary award the selection committee for the military section literary Onaward, which is open to all APHA members in the federal services who have contributed to pharmacy literature during 1966, are the followingCharles W. Bliven, executive secretary, American Association of Colleges of Pharmacy Charles B. Cleveland, editor, American Hospital Formulary Service Chauncey I. Cooper, dean, school of pharmacy, Howard University Edward F. Salim, director, APhA Foundation Drug Standards Laboratory
654
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
The award, sponsored by Eli Lilly and Company and presented at the APHA annual meeting, is given for the most outstanding paper published on pharmacy in the federal government during the past year. Topics for consideration include1. Pharmaceutical practice, education or administration 2. Pharmaceutical research 3. Pharmaceutical law, or legislation, or professional regulation
Pharmacists interested in being considered for the award, which consists of a $500 honorarium and an inscribed plaque, should send six copies of their published manuscript to APHA's Division of Governmental Pharmaceutical Services, 2215 Constitution Avenue N.W., Washington, D.C. 20037.