Comparative study of efficacy and safety of oral spironolactone versus oral isotretinoin in female patients with post-adolescent acne.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pillsbury grading scale, CADI, side effects
研究概览
简要总结
The study is based on post-adolescent acne in women (acne occurring after age 25), a condition with significant physical and psychosocial impact. It outlines the disease’s epidemiology, causes, clinical features, and treatment options, emphasizing its multifactorial nature involving hormones, genetics, lifestyle, and environmental triggers.
The study’s aim is to compare the efficacy and safety of Oral Spironolactone (100 mg/day) versus Oral Isotretinoin (0.5 mg/kg/day) in female patients with post-adolescent acne. Patients will be assessed over 3 months using the Pillsbury acne grading scale for severity and the Cardiff Acne Disability Index (CADI) for quality of life.
The methodology includes a prospective, interventional comparative design with 40 female patients (25–45 years, acne grade 2–3), randomized into two groups:
- Group A: Spironolactone + topical clindamycin
- Group B: Isotretinoin + topical clindamycin
Safety monitoring includes blood counts, liver function, lipid profile, and, in spironolactone patients, serum potassium and renal function.
Expected outcomes are to determine which drug is more effective and safer, thereby contributing to improved treatment strategies for post-adolescent acne.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •(1)All women of 25-45 years of age with acne of grade 2 and 3 (as per Pillsbury scale).
- •(2)Women with facial acne involving lower third of face (mandibular line, perioral region, and side of the neck).
- •(3)Cases willing to give informed consent.
排除标准
- •(1)Patients below the age of 25 years.
- •(2)Patients with grade 1 and 4 (as per Pillsbury scale) (3)Patients with predominately truncal acne.
- •(4)Patients who have been on any topical or systemic treatment in last 1 month.
- •(5)Patient who have undergone procedures such as any chemical peel, acne scar surgery in last 15 days prior to enrollment.
- •(6)Pregnant and lactating women.
- •(7)Patients planning to conceive.
- •(8)Females on contraceptive or other medication that cause or worsen acne.
- •(9)Patients on corticosteroids/antiepileptics/AKT/ART/antipsychotics.
- •(10)Patient suffering from acne rosacea and other bacterial infections on face confounding the diagnosis of acne vulgaris.
- •(11)Patient suffering from Androgen-secreting adrenal or ovarian tumour, Cushing’s syndrome, Congenital adrenal hyperplasia.
- •(12)Patients who are immune-compromised or taking immunosuppressant.
- •(13)Patients undergoing chemotherapy.
结局指标
主要结局
Pillsbury grading scale, CADI, side effects
时间窗: baseline, 2 week, 1 month, 2 month, 3 month
次要结局
- investigations: CBC, LFT, RFT, Hormonal profile, ultrasonography abdominal and pelvis, serum TSH, serum magnesium(baseline)
研究者
Dr Shivani Tripathi
SBKS MI & RC