MedPath

Clinical study on Namskar Ayurved’s Repair and Restore Moisturizing Body Oil

Phase 3
Completed
Registration Number
CTRI/2022/07/044468
Lead Sponsor
amaskar Ayurved Private Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
33
Inclusion Criteria

1.Clinically diagnosed mild to moderate skin dryness assessed using clinical grading score

2.Willing to comply with all requirements of the study.

Exclusion Criteria

1.Subjects with a known current history of chronic skin diseases or autoimmune diseases, such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo and rosacea

2.Subjects with a tattoo, a scar, moles, too many hairs or anything on the Right leg which might interfere with the evaluation.

3.Subjects with intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.

4.Subjects who have used facial blemish-lightening products (such as products claiming to have whitening or blemish-lightening effects), topical or oral whitening drugs. Moisturizing cream, lotion or oil within 21 days before entering the trial

5.Subjects on any other investigational products within 1 month prior to randomization

6.Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure, liver failure

7.Pregnant and lactating women

8.Known hypersensitivity to any of the ingredients of Namskar Ayurved’s Repair and Restore Moisturizing Body Oil

9.Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in skin cutaneous moisturization/skin drynessTimepoint: Screening / Baseline visit (Day 0), Visit 1 (24 hrs. post skin patch test application), Visit 2 (48 hrs. post skin patch test application) visit 3 (Day 15), visit 4 (Day 30)
Secondary Outcome Measures
NameTimeMethod
1.Changes in overall skin texture/roughness (Tactile) and (Visual) <br/ ><br>2.Changes in overall skin desquamation/flakiness and luminosity/radiance <br/ ><br>3.Change in facial skin lightening and blemishes on skin <br/ ><br>4.Assessment of 24 hr skin patch test <br/ ><br>5.Difference in number of comedones (blackheads and whiteheads) on the face and body <br/ ><br>6.Assessment of ability of study drug to absorb into the skin, oily/greasy appearance and feeling of oil on skin <br/ ><br>7.Global assessment for overall change by participants and by physician <br/ ><br>8.Assessment of post treatment tolerability of study drug by participants and physician. <br/ ><br>9.Assessment of adverse events <br/ ><br>Timepoint: Screening / Baseline visit (Day 0), Visit 1 (24 hrs. post skin patch test application), Visit 2 (48 hrs. post skin patch test application) visit 3 (Day 15), visit 4 (Day 30)
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