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
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in total score of Global Physician Assessment of Skin Wrinkles, Pores, Hydration/ Moisture, Brightness Tone, and Pigmentation of facial skin excluding scalp.
研究概览
简要总结
Fifty-Six healthy male and female of age more than equal to 18 years and less than equal to 60 will be assigned in 1:1 ratio to treatment with the test product, KSM-66 Ashwagandha Skin lotion or Placebo in this double-blind, randomized, placebo-controlled study. All 56 enrolled subjects will be asked to After cleansing, KSM-66 Ashwagandha® 2ml skin lotion should be applied to the face until well absorbed. Subjects will be required to apply daily once for 60 days at home. Subjects will be required to use diaries to document the date, time and dosage of the study treatments including any missed doses and the occurrence of any adverse events. The efficacy of investigational product will be assessed primarily with Change in total score of Global Physician Assessment of Skin Wrinkles, Pores, Hydration/ Moisture, Brightness Tone, and Pigmentation of facial skin excluding scalp will be evaluated and secondarily Mean change in TEWL and mean change in self-assessment questionnaire will be evaluated at baseline visit and at the end of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy adult men and women participants more than equal to 18 years and less than equal to 60 years of age.
- •2.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.
- •3.Participants willing to undergo preparation for Facial Skin Assessment.
- •4.Willingness to follow the protocol requirements as evidenced by written informed consent.
- •5.Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination.
- •6.Participants or LAR are able to and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
- •7.Participants with Fitzpatrick photo-type III-VI skin.
- •8.Participants who agree to take investigational product (i.e., Till Day 60 ± 4).
排除标准
- •1.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.
- •2.Participants having a history of hypersensitivity reactions (i.e., allergic or oversensitivity to usual doses).
- •3.Participants who have participated in a clinical study during the preceding 180 days.
- •4.Participants with a medical history of using a medicated acne treatment within the last 6 months.
- •5.Participants with active skin disease in the test area.
- •6.Participants with a medical history of dysplastic nevi or melanoma on the face.
- •7.Participants with moles, cysts, tattoos, scars, irritated skin, hairs, etc.
- •8.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.
- •10.Participants with a medical history of abnormal response to sunlight.
- •11.Participants with a history of mental illness.
- •12.Participants who are medically diagnosed acne vulgaris, acne conglobate, fulminans, secondary acne (drug induced acne) or any acne requiring systemic or topical treatment.
- •13.Participants who had an aesthetic, cosmetic or dermatological treatment in the treatment area (face) within the last month.
- •14.Participants who had intense sun exposure, Ultraviolet (UV)- treatments or tanning salon visit within the last 2 weeks.
- •15.Participants with a known or suspected intolerance, allergy or hypersensitivity to study materials (or closely related compounds) or any of their stated ingredients.
- •16.Participants with a history of allergies to cosmetic products or medicated acne treatments.
- •18.Participants working outdoors.
结局指标
主要结局
Change in total score of Global Physician Assessment of Skin Wrinkles, Pores, Hydration/ Moisture, Brightness Tone, and Pigmentation of facial skin excluding scalp.
时间窗: Baseline and Day 60 ± 4
The signs will be scored using a 6 point grading scale, (0 is equal to None, 1 is equal to Minimal,
时间窗: Baseline and Day 60 ± 4
2 is equal to Mild, 3 is equal to Moderate, 4 is equal to Moderately Severe, 5 is equal to Severe).
时间窗: Baseline and Day 60 ± 4
次要结局
- 1. Mean change in Transepidermal water loss (TEWL) from Visit 1, Screening Visit or Enrolment Visit or Baseline Visit, (Day 1) to Visit 3, End of study (Day 60 ± 4)(2. Mean change in Self - Assessment Questionnaire from Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) to Visit 3, End of study (Day 60 ± 4))