A randomized split-face double-blind control trial of the Efficacy of Hydroquinone-free skin brightening serum (Melacare) on Improvement of Melasma versus placebo in THAIS

Phase 4

Completed

• Conditions: Efficacy of of hydroquinone-free skin brightening serum (Melacare) on improvement of melasma compare to placebo in female 30-60 years; Melasma, mMASI, Mean Melanin Index, Natural additives

• Registration Number: TCTR20210604008
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-03-14
• Study Start: 2021-06-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

1. Thai female diagnosed with melasma, 2. Fitzpatrick skin type III-V, 3. Age between 30-60 years old, 4. Volunteers apply sunscreen regularly every day, 5. Volunteers have voluntarily agreed to participate in the trial of 6 weeks and signed a written consent to treatment.

Exclusion Criteria

1. Volunteers with the history of melasma treatment whether by topical, oral, or other tools and had not stopped receiving such treatment at least 4 weeks prior to the start of the study, 1.1. Topical drugs include drugs containing corticosteroids, vitamin A derivatives, hydroquinone, tranexamic acid, or whitening agents such as kojic acid, arbutin, licorice extract, ascorbic acid, azelaic acid. etc., 1.2 Oral medications including drugs or supplements that affect skin tone, 1.3 Tools such as exfoliating agents and various types of laser treatment of melasma, 2. Volunteers who are pregnant or breastfeeding or is likely to become pregnant, 3. Volunteers with a history of hormonal disorders or taking hormone-adjusting drugs, 4. Volunteers used oral contraceptives, 5. Volunteers had a history of allergy to the ingredients in the serum, including N-acetyl glucosamine, Tranexamic acid, Heaven white, Niacinamide, Alpha arbutin, Fish collagen, 6. Volunteers engage in occupations or jobs that require unavoidable exposure to the sun for long periods of time per day on a regular basis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified