Reducing the oral isotretinoin skin side effects: efficacy of 8% omega-ceramides, hydrophilic sugars, 5% niacinamide cream compound in acne patients.

BACKGROUND: Acne vulgaris is a chronic inflammatory skin disease that manifests as open and closed comedones as well as inflammatory papules, pustules, and nodules localized on face and trunk. Oral isotretinoin demonstrated to be effective in controlling seborrhea, inflammation, Propionibacterium Acnes hyperproliferation and reducing scarring, nevertheless muco-cutaneous side effects, particularly dryness, itching, bruising are commonly seen in patients under treatment with isotretinoin reducing the compliance to the treatment. We conducted a randomized controlled trial to evaluate the efficacy of a cream compound formulated in order to reduce the oral isotretinoin side effects (redness, dryness, itching) in patients affected by severe acne of the face.

METHODS: Twenty-seven patients undergoing treatment with 0.5-1 mg/kg/day for papulo-pustular or nodulo-cystic acne were randomized to additionally receive a cream composed of 8% omega-ceramides, hydrophilic sugars, 5% niacinamide applied twice daily (group A) or placebo cream (group B) applied 2 times per day.

RESULTS: During the whole treatment period and after 6 months of treatment, patients in the group A showed a greater reduction of dryness, itching and redness compared to the group receiving the placebo cream.

CONCLUSIONS: The cream formulated with 8% omega-ceramides, hydrophilic sugars, 5% niacinamide was effective in reducing xerosis and skin irritation, and was also successful in improving the patients' adherence to the oral isotretinoin treatment.