Efficacy and Safety of Ashwagandha topical lotion application on the Skin Health in Healthy Adults

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 56

Inclusion Criteria

Healthy adult men and women participants â‰¥ 18 years and â‰¤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 6.
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 8.
Participants who agree to take investigational product (i.e., Till Day 90 Â± 4).

Exclusion Criteria

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 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.
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 subjectsâ€” patients with uncontrolled, unstable comorbidities.
Participants working outdoors.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in total score of Global Physician Assessment	Baseline, 12 Weeks

Secondary Outcome Measures

Name	Time	Method
Transepidermal water loss (TEWL) measurement	Baseline, 12 Weeks
Self - Assessment Questionnaire	Baseline, 12 Weeks
Short Form Survey (SF-12)	Baseline, 12 Weeks

Trial Locations

Locations (1): D Y Patil Medical College Hospital and Research Centre
🇮🇳
Raigarh, MAHARASHTRA, India
D Y Patil Medical College Hospital and Research Centre
🇮🇳Raigarh, MAHARASHTRA, India
Sharmila Patil
Principal investigator
08850635503
sharmila.patil@dypatil.edu