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COMPLETED
NCT07849842
PHASE2

Mangosteen Gel for Sunburn-Like Skin Redness Caused by Ultraviolet B Light

Sponsor: Hasanuddin University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial was to learn whether a gel made from mangosteen (Garcinia mangostana) fruit rind helps sunburn-like skin redness fade faster when it is applied after the redness has already appeared. The trial was conducted in healthy adult women with Fitzpatrick skin phototypes IV-V. The main questions it aimed to answer were: * Does mangosteen pericarp extract gel reduce skin redness (measured as the chromameter a\* value) more than a placebo gel between Day 1 and Day 3? * Which concentration of the gel (2.5%, 5%, or 10%) works best, and is the gel well tolerated? Researchers compared three concentrations of mangosteen gel with a placebo gel and with untreated skin, all on the same person's back. Participants: * Had six small test areas marked on the upper back * Had five of these areas exposed to a measured dose of narrowband ultraviolet B light to cause mild redness, while one area was shielded * Had the assigned gels applied twice daily on Days 1 and 2, starting 24 hours after light exposure * Had skin color measured with a chromameter on Day 1 and Day 3, and were checked for skin reactions at each visit

Official title: Topical Mangosteen (Garcinia Mangostana) Pericarp Extract Gel for the Treatment of Narrowband Ultraviolet B-Induced Erythema: A Randomized, Double-Blind, Placebo-Controlled, Within-Person Trial

Key Details

Gender

All

Age Range

20 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2022-08-20

Completion Date

2022-11-23

Last Updated

2026-10-15

Healthy Volunteers

Yes

Interventions

DRUG

Topical Garcinia mangostana Pericarp Extract Gel 2.5%

A hydrophilic gel containing 2.5% (w/w) ethanolic Garcinia mangostana L. pericarp extract. Approximately 10 mg (2.77 mg/cm²) was applied to a randomly allocated test site at 08:00 and 16:00 on Days 1 and 2 (four applications), beginning 24 hours after narrowband ultraviolet B irradiation.

DRUG

Topical Garcinia mangostana Pericarp Extract Gel 5%

A hydrophilic gel containing 5% (w/w) ethanolic Garcinia mangostana L. pericarp extract. Approximately 10 mg (2.77 mg/cm²) was applied to a randomly allocated test site at 08:00 and 16:00 on Days 1 and 2 (four applications), beginning 24 hours after narrowband ultraviolet B irradiation.

DRUG

Topical Garcinia mangostana Pericarp Extract Gel 10%

A hydrophilic gel containing 10% (w/w) ethanolic Garcinia mangostana L. pericarp extract. Approximately 10 mg (2.77 mg/cm²) was applied to a randomly allocated test site at 08:00 and 16:00 on Days 1 and 2 (four applications), beginning 24 hours after narrowband ultraviolet B irradiation.

DRUG

Topical Placebo Gel

A hydrophilic gel containing the same excipients as the active gels and 0.02% (w/w) brown iron oxide to match the color of the 10% gel, without Garcinia mangostana pericarp extract. Approximately 10 mg (2.77 mg/cm²) was applied to a randomly allocated test site at 08:00 and 16:00 on Days 1 and 2, beginning 24 hours after narrowband ultraviolet B irradiation.

RADIATION

Narrowband Ultraviolet B Irradiation

Narrowband ultraviolet B irradiation, with an emission peak of approximately 311 nm, was administered at twice each participant's individually determined minimal erythema dose. Irradiation was delivered to the three active-treatment sites, the placebo site, and the untreated irradiated control site. A sixth untreated control site was not irradiated.

Locations (1)

Department of Dermatology, Venereology, and Aesthetics, Faculty of Medicine, Universitas Hasanuddin

Makassar, South Sulawesi, Indonesia