In vivo determination of the skin atrophy potential of the super-high-potency topical corticosteroid fluocinonide 0.1% cream compared with clobetasol propionate 0.05% cream and foam, and a vehicle.

PURPOSE: Prolonged topical corticosteroid use is often associated with atrophic skin changes. This trial compared signs of skin atrophy related to 3 super-high-potency corticosteroids: fluocinonide 0.1% cream, clobetasol propionate 0.05% cream, and 0.05% foam. PATIENTS AND METHODS: The test treatments were applied to the forearms 10 females twice daily for 21 days. Skin characteristics were assessed pretreatment and posttreatment for atrophic changes. Further punch biopsies obtained from 5 subjects were assessed histologically. RESULTS: Clobetasol foam produced mild changes in noninvasive tests, but stained skin biopsies revealed structural changes nearly comparable to clobetasol cream, which showed substantial atrophic changes. Fluocinonide cream was the least atrophogenic, producing no or only mild effects that were slightly greater than vehicle. CONCLUSIONS: Fluocinonide cream has a lower potential to produce atrophic changes of the skin than either clobetasol cream or clobetasol propionate foam.

Pilot investigation of the hydrating effects of topical acne medications.

Topical therapies are effective in managing acne vulgaris but are associated with local adverse effects such as irritation and dryness. This 4-week pilot study compared skin hydration in 36 healthy adult women randomized to treatment with 1 of 4 topical therapies: 2 different (jar and tube) clindamycin 1%/benzoyl peroxide 5% gels, sodium sulfacetamide 10% lotion, or over-the-counter (OTC) moisturizing cream. Subjects treated with OTC moisturizer or sodium sulfacetamide exhibited decreased water loss, increased water retention, similar or improved levels of skin hydration, and decreased desorption rates. In contrast, subjects treated with jar or tube clindamycin/benzoyl peroxide had increased water loss, decreased water retention, decreased hydration, and increased desorption rates. Skin dryness decreased slightly in the moisturizer group. No serious adverse events occurred. Overall, the OTC moisturizer had the best skin hydration profile. Sodium sulfacetamide demonstrated some moisturizing characteristics, and no clinically relevant differences were noted between jar and tube clindamycin/benzoyl peroxide gels.

Evidence that two alkyl ester quaternary ammonium compounds lack substantial human skin-sensitizing potential.

BACKGROUND: Alkyl ester quaternary ammonium compounds (ester quats) are used extensively in fabric rinse conditioners. It is important to document in the literature the outcome of historical studies that were performed to assess the risk of adverse skin effects associated with their use. OBJECTIVES: (1) To document the outcomes of historical studies performed to evaluate the skin sensitizing potential of two ester quats (the di-[hardened tallow fatty acid] ester of 2,3-dihydroxypropyl-trimethyl ammonium chloride [HEQ] and the dialkyl ester of triethanol ammonium methyl sulfate [TEA-Quat]) and (2) to demonstrate that these ester quats lack marked skin-sensitizing potential in humans, such that they do not present a risk of contact allergy for consumers who use fabric rinse conditioners. METHODS: Each material was assessed in the human maximization test in a panel of 25 volunteers. Diagnostic patch testing was also performed with each material in a population of 239 patients undergoing routine patch testing for suspected allergic contact dermatitis. These data are also considered in the context of an exposure-based quantitative risk assessment. RESULTS: Neither HEQ nor TEA-Quat was found to cause skin sensitization under the conditions of the human maximization test. No evidence of contact allergy to the materials was found among the relatively small population assessed by diagnostic patch testing. CONCLUSIONS: This study provides evidence that HEQ and TEA-Quat lack substantial skin-sensitizing potential in humans. Taken together with similar data for other ester quats, it suggests that compounds in this class are unlikely to be significant human contact allergens.

Soak and smear: a standard technique revisited.

BACKGROUND: Atopic dermatitis, nummular eczema, chronic hand dermatitis, palmar plantar psoriasis, and xerotic eczema are common inflammatory skin conditions. They may be refractory to conventional topical and even systemic treatment. Little evidence is available that demonstrates the benefits of aggressive topical treatment of patients with these disorders. OBJECTIVE: To describe a simple, inexpensive, effective topical treatment with an accompanying patient educational sheet. DESIGN: A retrospective study of 28 patients referred to a tertiary care center for refractory chronic pruritic eruptions. Intervention with a plain water 20-minute soak followed by smearing of mid-strength to high-strength corticosteroid ointment led to clearing or dramatic improvement. RESULTS: Objective and symptomatic improvement was obtained from aggressive topical treatment. It was well accepted in this group of referral patients. CONCLUSIONS: Hydration for 20 minutes before bedtime followed by ointment application to wet skin and alteration of cleansing habits is an effective method for caring for several common skin conditions. Prospective studies are needed to further validate these findings.

Effects of age on human cumulative irritation responses.

A 10-day cumulative irritation test was conducted to evaluate whether or not test subjects 65 years of age and older would rank eleven test materials the same as subjects 18 to 45 years of age The test materials consisted of mild to moderately irritating chemicals. The test articles were ranked similarly for both groups of subjects. Statistical analysis indicated no significant difference between the groups of subjects. Thus older subjects should not necessarily be excluded in comparative studies of irritancy.

Low dose isotretinoin combined with tretinoin is effective to correct abnormalities of acne.

BACKGROUND: Isotretinoin is well known in the therapy of acne papulopustulosa and acne conglobata. No study has investigated the pathophysiological changes of the skin of acne patients, especially when low dose oral isotretinoin is given in combination with topical tretinoin. PATIENTS AND METHODS: 28 patients were treated for 6 months with oral isotretinoin. In the acne conglobata group (A-C) patients were treated with 10 mg (Group A) or 20 mg isotretinoin (Groups B, C) in combination with topical 0.05% tretinoin cream. Group C was treated the first 2 weeks with 0.05% betamethasone valerate cream instead of tretinoin cream. In the acne papulopustulosa group, the patients received 0.5 mg isotretinoin/kg bodyweight and 0.05% tretinoin cream, either alone (Group E), or with oral methylprednisolone during induction (Group D). RESULTS: Acne conglobata--A reduction of inflammatory lesion by 87-94% and of non-inflammatory lesions by 81-88% was achieved (Groups A-C). A reduction of sebaceous gland size by 35-58%, sebum production by 90-95%, follicular keratinization by 55-70% and Propionibacteria by 33-73% was seen (Groups B and C better than Group A). In Group A the amount of lipids was only reduced by 6%, in Group B by 35% and in Group C by 40%. Acne papulopustulosa--Sebum excretion rate and follicular keratinization were reduced in Group D by 89% and 50% respectively, with isotretinoin alone by 94% and 53%. The amount of lipids was reduced in Group D by 40% and in Group E by 21%. CONCLUSIONS: Because of the efficacy and cost-benefit relationship of isotretinoin in the treatment of acne compared to other therapeutic approaches, further use low dose isotretinoin in the described settings seems to justified.

The 21-day human cumulative irritation test can be reduced to 14 days without loss of sensitivity.

The 21-day cumulative irritation test for assessing the irritancy of topical products and chemicals is a venerable procedure that appears to have become the gold standard for manufacturers. Berger and Bowman in 1982 (1) showed that reducing the exposure to 14 days was less traumatic to the volunteers, less costly, less arduous, and did not affect reliability or the capacity to place the test agents in the proper rank order of irritancy. In the current study we compared (a) the 21-day cumulative irritation test, (b) the 14-day cumulative irritation test, and (c) the 14-day test with every-other-day patching. Additionally, ten-day, seven-day and four-day data from the 21-day test were compared. Forty-one subjects completed this study of six test materials. Two sets of patches were applied to each subject' lower back. One set had 21 consecutive applications of the test articles. The second set was applied, and removal of the test articles occurred Monday, Wednesday, and Friday for 14 days. The 21-day test fully differentiated the test materials from each other. Using only the first 14 days of the 21-day test also fully differentiated the test materials. Every-other-day patching rank ordered the test materials the same as the everyday patching, but full differentiation of the test materials was not obtained. We conclude that the 14-day cumulative irritancy test is as reliable and sensitive as the 21-day test, along with the obvious advantages in time, cost, and minimization of trauma to the test subjects.

Cutaneous toxicity of chemical irritants on hairless Guinea pigs.

To evaluate the toxicity of irritant chemicals on animal skin, investigators have frequently had to apply high concentrations, owing to the fact that its susceptibility is less than that of human skin. High concentrations are so damaging to tissue that specific effects are obscured on the various layers. The aim of the present study was to elucidate the effects of a variety of irritating chemicals on the skin of hairless guinea pigs. Graded concentrations of these irritating substances were applied to the back for varying periods. Histologic changes were analyzed by light and electron microscopy. The structural alterations varied greatly among the chemicals, reflecting quite different mechanisms of action. Hairless guinea pigs are quite susceptible to chemical injury, especially to their hair follicles and dermal components. The hairless guinea pig appears to be an advantageous model to assess the acute and chronic effects of chemical irritants.