Study to Check the Effect and Safety of Ashwagandha Lotion in Aging by sunlight in Healthy Subjects.
- Registration Number
- CTRI/2022/11/047537
- Lead Sponsor
- Ixoreal Biomed
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 56
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).
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 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.
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 of Skin Wrinkles, Pores, Hydration/ Moisture, Brightness Tone, and Pigmentation of facial skin excluding scalp. <br/ ><br>The signs will be scored using a 6 point grading scale, (0 is equal to None, 1 is equal to Minimal, <br/ ><br>2 is equal to Mild, 3 is equal to Moderate, 4 is equal to Moderately Severe, 5 is equal to Severe).Timepoint: Baseline and Day 60 ± 4
- Secondary Outcome Measures
Name Time Method 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) <br/ ><br>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) <br/ ><br>3. Mean change in Self - Assessment Questionnaire (SF-12) scores from Visit 1, Screening Visit or Enrolment Visit or Baseline Visit, (Day 1) to Visit 3, End of study (Day 60 ± 4) <br/ ><br>4. Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE) over 08 weeks treatment periodTimepoint: Baseline and Day 60 ± 4