Evaluation of Efficacy and Safety of Kumkumadi Ghrit in participants suffering from Facial hyperpigmentation- 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
- Change in facial hyperpigmentation
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 Kumkumadi Ghrit in participants suffering from facial hyperpigmentation. Subjects will be advised to apply Kumkumadi Ghrit on face and massage for 1 minute once daily for a period of 30 days. The primary objective of the study will be to assess change in facial hyperpigmentation. Secondary objectives of the study will be to assess changes in photographic evaluation of Facial hyperpigmentation spot, change in skin lightening effect, change in skin glow, assessment of 24 hr skin patch test, change in facial cutaneous moisturization, changes in facial wrinkles, difference in number of comedones, assessment of ability of Kumkumadi Ghrit to absorb into the skin, oily/greasy appearance of skin after application of ghrit, feeling of Ghrit on skin, global assessment for overall change, assessment of post treatment tolerability of study drug and assessment of adverse events on screening / Baseline visit, 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:
Kumkumadi Ghrit showed significant reduction in facial hyperpigmentation(dark spots). It also showed skin lightening effect with significantimprovement in skin glow, facial moisturization, reduction in facial wrinklesand comedones.Use of Kumkumadi Ghrit was also found to be safe withoutproducing any adverse effects. Kumkumadi Ghrit can therefore be recommended as a safe and effectiveremedy for the management of facialhyperpigmentation (dark spots).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Clinically diagnosed mild to moderate facial hyperpigmentation 2.Willing to comply with all requirements of the study including being photographed, at baseline and following post treatment care and attending all treatment and follow up visits.
排除标准
- •1.Subjects who have received facial treatments within the past three months, including laser, RF (radio frequency), HIFU (high-intensity focus ultrasound), or dermal filler injection.
- •2.Subjects with a known current history of chronic skin diseases or autoimmune diseases, such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo and rosacea 3.Subjects who have used facial blemish-lightening products (such as products claiming to have whitening or blemish-lightening effects), topical or oral whitening drugs within 21 days before entering the trial 4.Subjects on any other investigational products within 1 month prior to randomization 5.Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure.
- •6.Pregnant women 7.Known hypersensitivity to any of the ingredients of Kumkumadi Taila 8.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
Change in facial hyperpigmentation
时间窗: Screening / Baseline visit, 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 photographic evaluation of Facial hyperpigmentation spot(2.Change in skin lightening effect)