Evaluation of Efficacy and Safety of Mformulae Acne Barrier Ritual and Mformulae Calming Matte for skin barrier repair in healthy participants with dry and sensitive skin. - 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
- 50
- 试验地点
- 1
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 Mformulae Acne Barrier Ritual and Mformulae Calming Matte for skin barrier repair in healthy participants with dry and sensitive skin. The study will be conducted in India at one centre. Subjects will be asked to apply Mformulae Calming Matte all over the face during day time (after bath) and Mformulae Acne Barrier Ritual for night routine (at least 30 minutes before going to bed) every day for a period of 30 days. The primary objectives of the study will be to assess change in investigator-assessed skin irritation, erythema, swelling, and itching and change in skin cutaneous moisturization/skin dryness. The secondary objectives of the study will be to assess change in water content or hydration of the skin surface as assessed using Corneometer, change in Trans epidermal water loss (TEWL) as assessed using Tewameter, change in calming or soothing effect, acceptance of scent or aroma as assessed using graded scale, changes in blemishes on skin, skin patch test using Dermal Response Score, difference in number of comedones (blackheads and whiteheads) on the face and body, ability of Mformulae Acne Barrier Ritual and Mformulae Calming Matte to absorb into the skin, oily or greasy appearance of skin after application of study products, feeling of oil on skin, global assessment of overall change by participants and physician, post treatment tolerability of study drug by participants and physician and adverse events/adverse drug reactions including vitals on baseline visit, 5 mins after application of product, day 15 and 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
- •Subjects having mild to moderate skin dryness and any one of the skin conditions i.e. irritation, erythema, swelling, and itching (assessed using clinical grading score) due to skin currently on retinoid treatment, reactive rosacea-prone (currently calm skin), atopy-prone (currently calm skin but has a history of easy flaring), skin currently on benzoyl peroxide treatment for acne, acne-prone/oily with dehydrated combination skin, post-procedure skin (7 to 14 days after chemical peel or microneedling treatment), post-procedure laser skin treatment (5 to 7 days after the treatment).
- •Willing to comply with all requirements of the study.
排除标准
- •Subjects with a known current history of chronic skin diseases or autoimmune diseases, such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo and rosacea
- •Subjects with a tattoo, a scar, moles, too many hairs or anything on the Right leg which might interfere with the evaluation.
- •Subjects with intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
- •Subjects who have used facial blemish-lightening products (such as products claiming to have whitening or blemish-lightening effects), topical or oral whitening drugs.
- •Moisturizing cream, lotion or oil 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, liver failure
- •Pregnant and lactating women
- •Known hypersensitivity to any of the ingredients of Mformulae Acne Barrier Ritual and Mformulae Calming Matte
- •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.
研究者
Dr Shaam Agarwal
Target Institute of Medical Education and Research Pvt Ltd.