Effectiveness of Ashwagandha topical lotion on the Skin Health in Healthy Adults
- Registration Number
- CTRI/2023/06/054483
- Lead Sponsor
- Ixoreal Biomed Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
skin
8. Participants who agree to take the investigational product (i.e., Till Day 90 ± 4).
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
month.
10. Participants with a medical history ofabnormal 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, 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in total score of Global Physician Assessment <br/ ><br>Timepoint: Baseline, 12 Weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method Self-Assessment Questionnaire <br/ ><br>Timepoint: Baseline, 12 Weeks;Short Form Survey (SF-12)Timepoint: Baseline, 12 Weeks;Trans epidermal water loss (TEWL) measurement <br/ ><br>Timepoint: Baseline, 12 Weeks