A Randomized, Open Label, Prospective study to compare Efficacy of Metformin vs. Doxycycline in patients with Acne Vulgaris
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The percentage change in inflammatory and total lesion counts at baseline , 4 weeks, 8 weeks, and 12 weeks.
研究概览
简要总结
Background: Acne, one of the most prevalent chronic inflammatory skin conditions nowadays, is treated with benzoyl peroxide (alone or in conjunction with topical antibiotics and oral antibiotics, mainly doxycycline). With puberty, sebum excretion starts to rise with the maximum level of growth hormone and insulin, like Growth Factor-1. IGF-1 plays an important role in the pathogenesis of acne. Oral metformin decreases IGF-1 levels and improves acne.
Methods: To evaluate the efficacy and safety of metformin vs. doxycycline, a prospective, randomized, open-label study is to be conducted on patients with acne vulgaris. The patients will be randomly assigned in a 1:1 ratio, consisting of 80 patients in each group. Group 1 will receive 500 mg of metformin tablets twice daily with a 5% benzoyl peroxide ointment once daily, and Group 2 will receive 100 mg of doxycycline tablets twice daily with a 5% benzoyl peroxide ointment once daily for 12 weeks. Patients will be assessed based on the Global Acne Grading System, Total Lesion Count, and Cardiff Acne Disability Index.
Novelty: To compare efficacy and safety of metformin vs. doxycycline in patients receiving prescription medication for acne vulgaris in dermatology (OPD, UPUMS, Saifai).
Expected Outcome: The change in inflammatory total lesion count from baseline at week 12 will be the primary effectiveness outcome. Improvement in GAGS grading, improvement in CADI scores at week 12, and improvement in two grades from baseline are the other secondary efficacy goals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Moderate-to-severe acne
- •Who had not received systemic or topical treatment in the past 4 weeks ( systemic antibiotics, retinoids, corticosteroids or immunosuppressive agents).
排除标准
- •Patients with systemic diseases, including diabetes mellitus, kidney/liver dysfunction,
- •Pregnant and lactating women,
- •Those who are reluctant to come for regular follow up,
- •Those who reported a positive history of allergy to the study drugs,
- •Those who used drugs that interact with metformin or doxycycline,
- •Those who used contraceptive medications containing estrogen or progesterone,
- •Addiction to smoking and alcohol,
- •History of migraine.
结局指标
主要结局
The percentage change in inflammatory and total lesion counts at baseline , 4 weeks, 8 weeks, and 12 weeks.
时间窗: at baseline, 4 weeks, 8 weeks, and 12 weeks.
次要结局
- improvement in GAGS grading, improvement in CADI score at week 12(at baseline, 12 weeks.)
研究者
KAPIL KAKTAN
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES