Efficacy and Safety of Adapalene Gel and Hyaluronic Acid Versus Adapalene Gel Alone in Mild to Moderate Acne Vulgaris

Condition(s) studied

Investigational drug(s) / intervention(s)

use of adapalene gel 0.1% and hyaluronic acid at bedtime: in this intervention a combination of adapalene gel 0.1% and hyaluronic acid will be used

use of adapalene gel 0.1% once daily at bedtime: in this intervention involves the use of adapalene gel 0.1% once daily only topically at bedtime

Study summary

Acne vulgaris affects around 85% of adolescents and young adults. Adapalene, a topical retinoid, is a common treatment but often causes irritation, leading to poor adherence. Hyaluronic acid (HA), known for its hydrating and anti-inflammatory properties, may help reduce these side effects.

This prospective, open-label, randomized controlled trial compares adapalene 0.1% gel combined with HA serum versus adapalene alone over 8 weeks in patients with mild to moderate acne. Key outcomes include acne lesion reduction, incidence and severity of side effects (erythema, dryness, scaling, stinging/burning, pruritus), and skin hydration assessed through the skin turgor test. Acne severity will be measured using the Acne Severity Index (ASI) and Investigator's Global Assessment (IGA) scale.

The study anticipates better efficacy, reduced irritation, and improved skin hydration with the combination therapy. Ethical approval was obtained, and informed consent will be secured from all participants.

Eligibility

Primary outcome measure(s)

• Local tolerance to the drugs scale — 8 weeks
  Local tolerance to the drugs will be evaluated by using the score: 0-none; 1-mild; 2-moderate; 3-severe for erythema, scaling, dryness, stinging or burning, and pruritus at each follow-up visit. The higher the score the lower the tolerance to the drugs. Minimum score is zero and maximum score is 15.

Trial sites (1)

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