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

ConditionAcne Vulgaris
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBadr University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with mild to moderate acne vulgaris who have not used topical retinoids or systemic acne treatments within the past 3 months will be included.

Disqualifiers

patients with severe acne, nodulocystic acne, secondary infections, known hypersensitivity to adapalene or hyaluronic acid, pregnant, or lactating individuals.

Trial design

Design model

Parallel

Treatments tested in this trial

  • use of adapalene gel 0.1% and hyaluronic acid at bedtime

    Drug

    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

    Drug

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: adapalene gel 0.1% once daily at bedtimeActive comparator 1 intervention
Group B: adapalene gel 0.1% once daily at bedtime and hyaluronic acidExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Local tolerance to the drugs scale

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.

Time frame
8 weeks

Secondary outcomes

1

investigator's global assessment (IGA)

investigator's global assessment (IGA) clinical tool will be used at baseline and every 2 weeks thereafter to assess the severity of acne and monitor treatment response. It is a 5-point ordinal scale that evaluates the overall severity of acne based on lesion count, type, and inflammation. Only patients with score of 2 (mild) or 3 (moderate) will be enrolled and followed up

Time frame
8 weeks
2

acne severity index

The acne severity index (ASI) will be assessed at baseline and at the end of the study to evaluate acne severity, considering both lesion count and distribution.The higher the score the poorer the outcomes. Minimum score is zero.

Time frame
8 weeks
3

skin turgor assessment

The skin turgor test will be used to assess skin hydration and the time it takes for the skin to return to its original position is observed (\> 2 seconds: moderate to severe dehydration, \<2 seconds, but not immediately: mild dehydration, and immediately: absent dehydration).

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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