Evaluation of Efficacy and Safety of Desa Kumkumadi Ghrita in participants suffering from Facial hyperpigmentation- An open label, non-comparative, interventional, prospective, clinical study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in facial hyperpigmentation spot
研究概览
简要总结
It is a clinical study on Desa Kumkumadi Ghrita in participants suffering from Facial hyperpigmentation. The study will be conducted at one center in India. Subjects will be asked to apply Desa Kumkumadi Ghrita on face and massage for 1 minute once daily for a period of 30 days. Subjects will be asked to retain Desa Kumkumadi Ghrita on face for at least 1 hour then wash face with warm water. The primary objective of the study will be to assess change in facial hyperpigmentation spot. The secondary objectives of the study will be to assess changes in photographic evaluation of Facial hyperpigmentation spot, skin lightening effect, skin glow, assessment of 24 hours skin patch test, facial cutaneous moisturization, facial wrinkles (periorbital and perioral), difference in number of comedones (blackheads and whiteheads) on the face, ability of Desa Kumkumadi Ghrita to absorb into the skin, oily or greasy appearance of skin after application of Ghrita, feeling of Ghrita on skin, global assessment of 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 baseline visit (day 0), day 15 and end of study visit (Day 30)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed mild to moderate facial hyperpigmentation, facial solar lentigines, melasma, post inflammatory hyperpigmentation, periorbital hyperpigmentation, post acne dark spots.
- •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
- •Subjects who have received facial treatments within the past three months
- •Subjects with a known current history of chronic skin diseases or autoimmune diseases, such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo and rosacea
- •Subjects who have used facial blemish-lightening products, topical or oral whitening drugs within 21 days before entering the trial
- •Subjects on any other investigational products within 1 month prior to randomization
- •Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure.
- •Pregnant women
- •Known hypersensitivity to any of the ingredients of Desa Kumkumadi Ghrit
- •Dosage and Treatment Duration Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his or her participation in, and completion of the study.
结局指标
主要结局
Change in facial hyperpigmentation spot
时间窗: Baseline visit (day 0), day 15 and end of study visit (Day 30)
次要结局
- 1. Changes in photographic evaluation of Facial hyperpigmentation spot.(2. Change in skin lightening effect.)
研究者
Dr Anand M Pawar
Late B.V. Kale & Manjara Ayurved Medical College & Hospital