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

NCT07473895 | Not Yet Recruiting Phase 2

• 1 other identifier: AUN-DERM-ACNE-2026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acne vulgaris; Spironolactone; Adapalene; Topical therapy; Split-face study; Antiandrogen thearapy; Nano-Formulation; Dermatology; Acne treatment

Outcome Measures

Primary Outcomes (1)

• Measure the Change in Acne Severity via Global Acne Grading System (GAGS)

  The GAGS is used to calculate acne severity separately for each half of the face. The face is divided into regions (forehead, cheeks, nose, chin) with assigned area factors. Each region is graded from 0 (no lesion) to 4 (nodule); the regional score is the product of the most severe lesion grade and the area factor

  Baseline and 8 weeks (end of treatment)

Secondary Outcomes (4)

• Measure Comparative Change in Global Acne Grading System (GAGS) Score

  8 weeks

• Measure The Reduction in Total Lesion Count (TLC)

  Baseline and 8 weeks

• Measure Change in Quality of Life Using the Cardiff Acne Disability Index (CADI)

  Baseline and 8 weeks.

• Measure Patient Treatment Satisfaction Assessed by the Dermatology Treatment Satisfaction Questionnaire (DermSat-7)

  8 weeks

Study Arms (2)

Topical 5% Spironolactone Gel nano-formulation.

EXPERIMENTAL

Participants will apply topical 5% spironolactone nano-formulation gel to one side of the face once daily during the study period to evaluate its efficacy and safety in the treatment of acne vulgaris.

Drug: Spironolactone 5% Topical Gel

Topical 0.1% Adapalene Gel

ACTIVE COMPARATOR

Participants will apply topical 0.1% adapalene gel to the opposite side of the face once daily during the study period for comparison of efficacy and safety.

Drug: Adapalene 0.1% Topical Gel

Interventions

Spironolactone 5% Topical Gel DRUG

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.

Also known as: Topical Spironolactone, Spironolactone Nano-Gel, Spironolactone 5% Gel

Topical 5% Spironolactone Gel nano-formulation.

Adapalene 0.1% Topical Gel DRUG

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

Also known as: Topical Adapalene, Adapalene Gel, Adapalene 0.1%

Topical 0.1% Adapalene Gel

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-45 years old.
• Patients with mild to moderate bilateral acne vulgaris on the face.
• Presence of non-inflammatory acne (open and closed comedones).
• Presence of inflammatory papules and pustules.

You may not qualify if:

• Pregnancy and lactation.
• Patients taking oral contraceptive pills or any hormonal treatment.
• Patients who were using topical or systemic medications for acne in the last two months prior to starting therapy.
• Patients who had received laser resurfacing, chemical peeling, mesotherapy, or any similar facial interventions.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (7)

• Charakida A, Charakida M, Chu AC. Double-blind, randomized, placebo-controlled study of a lotion containing triethyl citrate and ethyl linoleate in the treatment of acne vulgaris. Br J Dermatol. 2007;157(3):569-574. DOI: 10.1111/j.1365-2133.2007.08083.x.

  BACKGROUND

• Elradi M, Hamed DE, Eltwansy MS, Hosny D. The impact of acne on quality of life: A cross-sectional study from Egypt. Skin Appendage Disord. 2025;11(3):255-261. DOI: 10.1159/000543051.

  BACKGROUND

• Bae IH, Kwak JH, Na CH, et al. A comprehensive review of the acne grading scale in 2023. Ann Dermatol. 2024;36(2):65-73. DOI: 10.5021/ad.23.094.

  BACKGROUND

• Shields A, Armstrong AW, Kaur MN, et al. Evaluation of DermSat-7 for assessing treatment satisfaction in patients with acne. JAMA Dermatol. 2024;160(1):88-92. DOI: 10.1001/jamadermatol.2023.4481.

  BACKGROUND

• Althwanay A, AlEdani EM, Kaur H, et al. Efficacy of Topical Treatments in the Management of Mild-to-Moderate Acne Vulgaris: A Systematic Review. Cureus. 2024;16(4).

  BACKGROUND

• Dereiah S, Ghori MU, Conway BR. A systematic review of spironolactone nano-formulations for topical treatment of skin hyperandrogenic disorders and chronic wounds. Pharmaceutics. 2024;17(1):27. DOI: 10.3390/pharmaceutics17010027.

  BACKGROUND

• Zhu Z, Zhong X, Luo Z, et al. Global, regional and national burdens of acne vulgaris in adolescents and young adults aged 10-24 years from 1990 to 2021: a trend analysis. Br J Dermatol. 2025;192(2):228-237.

  BACKGROUND

Related Links

• WHO Unified Medical Dictionary used for Arabic terminology in the study.

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Spironolactone; Gels; Adapalene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Mai Ahmed Ahmed

CONTACT

01123095269; Mai1998530@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open-label study in which both participants and investigators are aware of the treatment applied to each side of the face due to differences in formulation and application instructions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at dermatology, venereology and andrology department

Model Details: Participants with acne vulgaris will be enrolled in a split-face comparative study. Each participant will apply topical 5% spironolactone nano-formulation gel to one side of the face and topical 0.1% adapalene gel to the opposite side. This design allows each participant to serve as their own control and enables direct comparison of treatment efficacy and safety between the two topical therapies.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)