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.
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.
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.
Parallel
Spironolactone 5% Topical Gel
DrugThis 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.
Adapalene 0.1% Topical Gel
DrugA third-generation retinoid applied once daily at night to the opposite half of the face.
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
Measure Comparative Change in Global Acne Grading System (GAGS) Score
The difference in acne severity between the two treated sides of the face will be evaluated using the Global Acne Grading System (GAGS). The GAGS assesses acne severity by evaluating six anatomical locations (forehead, right cheek, left cheek, nose, chin, and chest/upper back). Each location is assigned a factor based on surface area and lesion type (comedones, papules, pustules, and nodules). The total score ranges from 0 to 44, where higher scores indicate more severe acne. The study will compare the reduction in GAGS scores between the facial side treated with topical 5% spironolactone nano-formulation gel and the side treated with topical 0.1% adapalene gel.
Measure The Reduction in Total Lesion Count (TLC)
Sum of both inflammatory (papules, pustules) and non-inflammatory (open and closed comedones) lesions on each side of the face.
Measure Change in Quality of Life Using the Cardiff Acne Disability Index (CADI)
Quality of life will be assessed using the Cardiff Acne Disability Index (CADI), a validated patient-reported questionnaire designed to measure the psychological and social impact of acne. The CADI consists of 5 questions, each scored from 0 to 3, resulting in a total score ranging from 0 to 15. Higher scores indicate greater impairment in quality of life related to acne. The Arabic validated version of the CADI will be used in this study. Changes in CADI scores will be assessed from baseline to 8 weeks of treatment.
Measure Patient Treatment Satisfaction Assessed by the Dermatology Treatment Satisfaction Questionnaire (DermSat-7)
Patient satisfaction with treatment will be assessed using the Dermatology Treatment Satisfaction Questionnaire (DermSat-7). This patient-reported instrument contains 7 items evaluating treatment effectiveness, convenience, tolerability, and overall satisfaction. Each item is rated on a 5-point Likert scale, resulting in a total score range from 7 to 35. Higher scores indicate greater treatment satisfaction. Scores will be evaluated at the end of the treatment period.
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