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Topical 5% Spironolactone Gel Versus 0.1% Adapalene Gel for Acne Vulgaris: A Randomized Split-Face Study

NCT07473895 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-17

No results posted yet for this study

Summary

Acne vulgaris is one of the most common dermatological conditions affecting adolescents and young adults. It results from multiple pathogenic factors, including increased sebum production, follicular hyperkeratinization, colonization by Cutibacterium acnes, and inflammation. Topical retinoids such as adapalene are widely used as first-line therapy; however, they may cause irritation and are not always effective in all patients. Recently, topical antiandrogen therapies such as spironolactone have gained attention because of their ability to reduce sebum production and improve acne lesions.

This study aims to evaluate the efficacy and safety of a topical 5% spironolactone gel nano-formulation compared with 0.1% adapalene gel in the treatment of acne vulgaris. A split-face study design will be used in which each participant will receive spironolactone gel on one side of the face and adapalene gel on the other side. This design allows each participant to serve as their own control and helps reduce variability in treatment response.

Participants diagnosed with acne vulgaris will be enrolled and treated for a defined follow-up period. Clinical assessment will be performed at baseline and during scheduled follow-up visits to evaluate improvement in acne lesions and monitor possible adverse effects. The primary outcomes will include changes in acne lesion counts and clinical severity scores. Safety and tolerability of both treatments will also be assessed.

The results of this study may provide evidence regarding the effectiveness of topical spironolactone nano-formulation as a potential alternative or adjunct therapy for acne vulgaris.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Spironolactone 5% Topical Gel

This is a drug-loaded nanospanlastics dispersion (using Span 60 and Tween 40) fabricated via the ethanol injection technique. It is applied twice daily to one half of the face for 8 weeks.

DRUG

Adapalene 0.1% Topical Gel

A third-generation retinoid applied once daily at night to the opposite half of the face.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07473895 on ClinicalTrials.gov