Clinical study on Kumkumadi Taila in Facial dark patches.

Phase 2

Completed

• Conditions: Health Condition 1: L819- Disorder of pigmentation, unspecified

• Registration Number: CTRI/2022/06/043014
• Lead Sponsor: amaskar Ayurved Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-07-27
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

1.Clinically diagnosed mild to moderate facial hyperpigmentation

2.Willing to comply with all requirements of the study including being photographed, at baseline and following post treatment care and attending all treatment and follow up visits

Exclusion Criteria

1.Subjects who have received facial treatments within the past three months, including laser, RF (radio frequency), HIFU (high-intensity focus ultrasound), or dermal filler injection.

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

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

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

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

6.Pregnant women

7.Known hypersensitivity to any of the ingredients of Kumkumadi Taila

8.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

Name	Time	Method
Change in facial hyperpigmentation.Timepoint: Screening / Baseline visit, 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

Name	Time	Method
1.Changes in photographic evaluation of Facial hyperpigmentation spot <br/ ><br>2.Change in skin lightening effect <br/ ><br>3.Change in skin glow <br/ ><br>4.Assessment of 24 hr skin patch test <br/ ><br>5.Change in facial cutaneous moisturization <br/ ><br>6.Changes in facial wrinkles <br/ ><br>7.Difference in number of comedones <br/ ><br>8.Assessment of ability of Kumkumadi oil to absorb into the skin <br/ ><br>9.Assessment of oily/greasy appearance of skin after application of oil <br/ ><br>10.Assessment of feeling of oil on skin <br/ ><br>11.Global assessment for overall change <br/ ><br>12.Assessment of post treatment tolerability of study drug <br/ ><br>13.Assessment of adverse events <br/ ><br>Timepoint: Screening / Baseline visit, 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)