CTRI/2023/06/054483招募中Unknown
A Prospective, Randomized, Double-Blind, Placebo Controlled Clinical Study to Evaluate the Efficacy & Safety of Ashwagandha Lotion in Photo-Aged Healthy Subjects
试验速览
- 阶段
- Unknown
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Healthy adult men and women participants? 18 years and ?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 not clinically significant and relevant abnormalities in medical history or upon physical examination
- •6. Participants or LAR can and are 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
- •8. Participants who agree to take the investigational product (i.e., Till Day 90 ± 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. at the test area that could influence the investigation
- •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.
- •9. Participants on systemic use of anti-microbials within the last
- •10. Participants with a medical history ofabnormal response to
- •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, 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.
- •17. Participants with any other condition which the principal
- •investigator thinks may jeopardize the safety of subjects— patients
- •with uncontrolled, unstable comorbidities.
- •18. Participants working outdoors.
研究者
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