Clinical and Microbiological Evaluation of Topical Dutasteride as a Potential New Therapy of Facial Acne Vulgaris Versus the Triple Combination Therapy (Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Evaluate and compare the therapeutic efficacy (clinical, microbiological & psychological) of topical Dutasteride 0.05% versus topical fixed-dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% gel in patients with facial AV
研究概览
简要总结
Acne vulgaris (AV) is one of the most prevalent dermatological conditions worldwide, affecting approximately 85% of adolescents and young adults between the ages of 12 and 24 years .While acne is often self-limiting, it can have profound psychosocial implications as individuals with acne are more likely to experience emotional distress, lower self-esteem and anxiety disorders .
Acne Vulgaris is a chronic inflammatory skin condition affecting the pilosebaceous units that leads to the development of different skin lesions such as comedones, papules, pustules, nodules and cystic lesions .
详细描述
The pathogenesis of AV involves the interaction of several host factors, including the stimulation of sebaceous glands by circulating androgens, follicular occlusion, dysbiosis of the pilosebaceous unit, and cellular immune/inflammatory responses .
Despite the availability of a wide range of treatment modalities, acne management remains challenging due to factors such as antibiotic resistance, patient adherence issues, and the varying response to treatments based on individual skin types . However, recent advances in understanding the pathogenesis of acne and developing novel therapeutic modalities have reshaped the landscape of its management .
Topical treatments remain the cornerstone of initial acne therapy and are favored over systemic options due to their lower risk of adverse effects and suitability for prolonged use. However, increasing concerns over antibiotic resistance and suboptimal outcomes have led to the exploration of alternative topical therapies .
The American Academy of Dermatology guidelines recommend a multimodal approach to therapy incorporating agents with multiple mechanisms of action to address the multifactorial pathogenesis of acne .Thus, combining treatments in an easy-to-use, fixed-dose formulation can improve treatment adherence by reducing complex drug regimens hence improve efficacy .
Adapalene is a third-generation retinoid that modulates cellular keratinization, differentiation, and proliferation . Furthermore, it is one of the most tolerable retinoids that retains its stability in the presence of Benzoyl peroxide (BPO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with facial acne vulgaris older than 18 years.
排除标准
- •· Unrealistic expectations.
- •Unable to follow up.
- •Severe and nodulocystic AV.
- •Patients on topical treatment for AV (4 weeks before enrollment) and on systemic treatment for AV (3 months before enrollment).
- •Patients on any systemic medication 3 months before enrollment.
- •Suspicion of malignancy, including prostate cancer
- •History of infertility or difficulty in fathering children.
- •Pregnancy & lactation.
- •Planning to become pregnant during study period or 6 months after ending treatment
- •Patients with any concomitant dermatologic or systemic illness.
研究组 & 干预措施
Topical Dutasteride 0.05% gel versus placebo (Petrolatum) (split face).
干预措施: topical dutasteride (Drug)
Topical Dutasteride 0.05% gel versus topical triple fixed-dose combination
干预措施: topical dutasteride (Drug)
结局指标
主要结局
Evaluate and compare the therapeutic efficacy (clinical, microbiological & psychological) of topical Dutasteride 0.05% versus topical fixed-dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% gel in patients with facial AV
时间窗: 16 weeks
o Total lesions count (TLC) (inflammatory lesions and noninflammatory lesions)
Evaluate and compare the therapeutic efficacy (clinical, microbiological & psychological) of topical Dutasteride 0.05% versus topical fixed-dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% gel in patients with facial AV
时间窗: 12 weeks
o The investigator's global assessment (IGA) of acne severity grade modified to assess the half-face acne severity ; Treatment success will be defined as an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear), and a 2-grade or greater improvement from baseline at week 12.
次要结局
- Addressing the safety profile of the two topical therapeutics(12 weeks)
- Psychological effect of AV and its relation to therapeutic outcomes(12 weeks)
研究者
Ola Ahmed Elminshawy
Principal investigator
Assiut University