Specific gel-cream as adjuvant to oral isotretinoin improved hydration and prevented TEWL increase--a double-blind, randomized, placebo-controlled study.

BACKGROUND: Hydrating and emollient products are often recommended to patients under isotretinoin therapy to control the most frequent mucocutaneous side effects and to improve adherence to treatment. AIMS: To assess, using noninvasive biophysical tests, the clinical and instrumental effectiveness of a hydrating gel-cream compared with placebo as an adjuvant to isotretinoin for treatment of facial skin in patients with inflammatory acne.
METHODS: Prospective, double-blind, randomized study, using MULTI SKIN MC750, on the adjuvant effect of a hydrating gel-cream for acne (active product) vs. a gel-cream without active substances (placebo). Follow-up lasted 3 months.
RESULTS: Sixty-six patients were included. Thirty-four were administered the active product, and 32 placebo. Though the number of lesions fell significantly in both groups, the mean number of papules on day 30 was significantly lower in the active product group. The active product group showed a significant increase in hydration, while the placebo group showed a significant increase in transepidermal water loss (TEWL). Seborrhoea decreased significantly in both groups; there were no differences between them.
CONCLUSIONS: Compared with placebo, the specific gel-cream with active products as an adjuvant to oral isotretinoin improved hydration, prevented TEWL increase, and reduced inflammatory acne lesions after 30 days.

RCT Entities:   Population Interventions Outcomes