Efficacy and Safety of Topical 5% Spironolactone Gel Nano-Formulation Versus 0.1% Adapalene Gel in the Management of Acne Vulgaris: A Split-Face Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Measure the Change in Acne Severity via Global Acne Grading System (GAGS)
研究概览
简要总结
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.
详细描述
Acne vulgaris is a chronic inflammatory disorder of the pilosebaceous unit that affects a large proportion of adolescents and young adults worldwide. The condition is characterized by the development of comedones, papules, pustules, and in severe cases nodules and cysts. The pathogenesis of acne involves multiple mechanisms including follicular hyperkeratinization, excessive sebum production stimulated by androgens, colonization with Cutibacterium acnes, and inflammatory responses within the pilosebaceous unit.
Topical retinoids are considered a cornerstone in the management of acne vulgaris due to their comedolytic and anti-inflammatory properties. Adapalene, a third-generation topical retinoid, is commonly used because of its efficacy and relatively favorable tolerability profile. Despite these advantages, some patients experience skin irritation, dryness, and erythema, which may limit adherence and treatment outcomes.
Spironolactone is an antiandrogen medication traditionally used orally for the treatment of hormonal acne, particularly in females. It acts by blocking androgen receptors and reducing sebaceous gland activity, thereby decreasing sebum production. However, systemic administration may be associated with potential adverse effects. Topical formulations of spironolactone have been proposed as an alternative approach to deliver antiandrogen effects locally while minimizing systemic exposure.
Recent advances in pharmaceutical technology, including nano-formulation delivery systems, may enhance the penetration and stability of topical medications and improve therapeutic outcomes. A topical 5% spironolactone gel nano-formulation may provide improved skin penetration and targeted delivery to the pilosebaceous unit.
The present study is designed as a split-face comparative clinical study to evaluate the efficacy and safety of topical 5% spironolactone gel nano-formulation compared with topical 0.1% adapalene gel in patients with acne vulgaris. In this design, each participant will apply spironolactone gel to one side of the face and adapalene gel to the other side according to the study protocol. This approach allows direct comparison of the two treatments within the same individual and minimizes inter-individual variability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Topical 0.1% Adapalene Gel
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.
干预措施: Adapalene 0.1% Topical Gel (Drug)
Topical 5% Spironolactone Gel nano-formulation.
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.
干预措施: Spironolactone 5% Topical Gel (Drug)
结局指标
主要结局
Measure the Change in Acne Severity via Global Acne Grading System (GAGS)
时间窗: Baseline and 8 weeks (end of treatment)
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
次要结局
- Measure The Reduction in Total Lesion Count (TLC)(Baseline and 8 weeks)
- Measure Comparative Change in Global Acne Grading System (GAGS) Score(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)
研究者
Mai Ahmed Thabet Ahmed
Resident at dermatology, venereology and andrology department
Assiut University