CTRI/2022/09/045512进行中（未招募）不适用
A Prospective, Double-Blind, Randomized, Parallel, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Ashwagandha Lotion in Photo-Aged Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in total score of Global Physician Assessment
研究概览
简要总结
All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study.
Subjects will be informed about the purpose of the study and signed informed consent will be taken.
Efficacy assessments mentioned above will be done appropriately during the study.
All Subjects will be followed-up during the study period (Screening /Baseline, Day-45 (telephonic),and Day 90 ± 4) till complete the course of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy adult men and women participants ≥ 18 years and ≤60 years of age.
- •Participants who agree not to use any medication (prescription and over the counter), including vitamins and minerals, during or before the course of this study.
- •Willingness to follow the protocol requirements as evidenced by written informed consent.
- •Good general and mental health with, in the opinion of the investigator or medically qualified designee not clinically significant and relevant abnormalities in medical history or upon physical examination
- •Participants or LAR can and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
- •Participants with Fitzpatrick photo-type III-VI skin
- •Participants who agree to take investigational product (i.e., Till Day 90 ± 4).
排除标准
- •Participants having any clinically significant medical history, medical finding including rosacea, eczema, psoriasis, and atopic dermatitis or an on-going medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
- •Participants having a history of hypersensitivity reactions (i.e., allergic or oversensitivity to usual doses).
- •Participants who have participated in a clinical study during the preceding 180 days.
- •Participants with a medical history of using a medicated acne treatment within the last 6 months.
- •Participants with active skin disease in the test area.
- •Participants with a medical history of dysplastic nevi or melanoma on the face.
- •Participants with moles, cysts, tattoos, scars, irritated skin, hairs, etc.
- •at the test area that could influence the investigation
- •Participants on systemic therapy with immuno-suppressive drugs (e.g., corticosteroids) and/or antihistamines within 7 days prior to the start of the study and/or throughout the entire course of the study.
- •Participants with a medical history ofabnormal response to sunlight.
- •Participants with a history of mental illness.
- •Participants who are medically diagnosed acne vulgaris, acne conglobate, fulminans, secondary acne (drug induced acne) or any acne requiring systemic or topical treatment.
- •Participants who had an aesthetic, cosmetic or dermatological treatment in the treatment area (face) within the last month.
- •Participants who had intense sun exposure, UV-treatments or tanning salon visit within the last 2 weeks.
- •Participants with a known or suspected intolerance, allergy, or hypersensitivity to study materials (or closely related compounds) or any of their stated ingredients.
- •Participants with a history of allergies to cosmetic products or medicated acne treatments.
- •Participants with any other condition which the principal investigator thinks may jeopardize the safety of subjects— patients with uncontrolled, unstable comorbidities.
- •Participants working outdoors.
结局指标
主要结局
Change in total score of Global Physician Assessment
时间窗: Baseline, 12 Weeks
次要结局
- Transepidermal water loss (TEWL) measurement(Baseline, 12 Weeks)
- Self - Assessment Questionnaire(Baseline, 12 Weeks)
- Short Form Survey (SF-12)(Baseline, 12 Weeks)
研究者
研究点 (1)
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