Evaluation of Efficacy and Safety of Anti-acne Spot Oil in participants suffering from Acne Vulgaris- An open label, non-comparative, interventional, prospective, clinical study.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in total number of inflammatory acne lesions on face
研究概览
简要总结
It is an open label, non-comparative, interventional, prospective, clinical study to evaluate efficacy and safety of Anti-acne spot oil in participants suffering from Acne Vulgaris. Subjects will be asked to apply Anti-acne Spot Oil on acne lesions twice daily for a period of 30 days. Subjects will be advised to retain Anti-acne Spot Oil on face. The primary objective of the study will be to assess changes in total number of inflammatory acne lesions on face. The secondary objectives of the study will be to assess total numbers of non-inflammatory acne lesions, total lesion count (inflammatory and non-inflammatory), difference in number of comedones (blackheads and whiteheads), severity of acne vulgaris, signs and symptoms, acne scarring, post acne dark spots, 24 hr skin patch test, ability of Anti-acne Spot Oil to absorb into the skin, oily/greasy appearance of skin after application of oil, feeling of oil on skin, global assessment for overall change by participants and by physician, post treatment tolerability of study drug by participants and physician and adverse events/adverse drug reactions including vitals on screening / baseline visit (Day 0), Visit 1 (24 hrs. post skin patch test application), Visit 2 (48 hrs. post skin patch test application) visit 3 (Day 15), visit 4 (Day 30)
Results and Conclusion:
Namaskar Ayurved Anti-acne spot oil waseffective in significantly reducing inflammatory, non-inflammatory acnelesions, comedones (blackheads andwhiteheads), symptoms of acne vulgaris including pain, edema, erythema,burning, post acne dark spot, acne scarring and severity of acne vulgaris.Namaskar Ayurved Anti-acne spot oil was found to be safe in subjects forregular use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects suffering from acne vulgaris [mild and moderate as per Global Acne Grading System (GAGS)] as diagnosed by physician or dermatologist 2.Subjects willing to follow study instructions given by the investigator.
排除标准
- •1.Subjects with known pre-existing systemic disease necessitating long-term medications.
- •2.Subjects with known current endocrinal disorders.
- •3.Subjects taking treatment for menstrual disorders 4.Subjects having systemic treatment for acne vulgaris.
- •5.Subjects on any other investigational products within 1 month prior to randomization; 6.Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure.
- •7.Pregnant and lactating women 8.Known hypersensitivity to any of the ingredients of Anti-acne Spot Oil 9.Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study.
结局指标
主要结局
Changes in total number of inflammatory acne lesions on face
时间窗: Screening / Baseline visit (Day 0), Visit 1 (24 hrs. post skin patch test application), Visit 2 (48 hrs. post skin patch test application) visit 3 (Day 15), visit 4 (Day 30)
次要结局
- 1.Changes in total numbers of non-inflammatory acne lesions(2.Changes in total lesion count (inflammatory and non-inflammatory))