None listed
Conditions
Interventions
Intervention1: Ashwagandha topical lotion
formulation: Ashwagandha topical lotion to
be applied two times daily for 90 days.
Control Intervention1: Identical Placebo lotion
formulation: Identical Plac
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total score of Global Physician Assessment Timepoint: Baseline, 12 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-Assessment Questionnaire Timepoint: Baseline, 12 Weeks;Short Form Survey (SF-12)Timepoint: Baseline, 12 Weeks;Trans epidermal water loss (TEWL) measurement Timepoint: Baseline, 12 Weeks | — |
Countries
India
Contacts
Public ContactShylaja Someshwar
MGM Medical College
Outcome results
None listed