Post-Exposure Mangosteen Gel for NB-UVB-Induced Skin Redness

NCT07849842 | Completed

• 1 other identifier: UH22030115
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated whether topical mangosteen pericarp extract gel reduced early skin redness when treatment was initiated after narrowband ultraviolet B-induced erythema had developed. Healthy adult volunteers underwent photoprovocation at six separate test sites on the back. Twenty-four hours after irradiation, the sites were randomly assigned to receive 2.5%, 5%, or 10% mangosteen gel, vehicle gel, no topical treatment after irradiation, or neither irradiation nor topical treatment. Skin redness was assessed colorimetrically before the first topical application and again after four applications over 48 hours.

Conditions

Narrowband Ultraviolet B-Induced Skin Erythema

Keywords

Mangosteen; Garcinia mangostana; Narrowband ultraviolet B; Topical gel; Photoprovocation

Outcome Measures

Primary Outcomes (1)

• Change in Skin Redness From Day 1 to Day 3 Assessed by the CIELAB a* Coordinate

  Skin redness was measured using a calibrated CR-400 chromameter. Three consecutive measurements were obtained at each test site and averaged. Day 1 measurements were performed 24 hours after irradiation and before the first topical application. Day 3 measurements were performed after four topical applications over 48 hours. Reduction in redness was calculated as Day 1 a\* minus Day 3 a\*. Higher positive values indicate a greater reduction in skin redness. Changes were compared across the six conditions within each participant.

  Day 1, 24 hours after NB-UVB exposure and before treatment; and Day 3, 72 hours after NB-UVB exposure and after 48 hours of treatment

Study Arms (6)

Mangosteen Gel 2.5% After NB-UVB

EXPERIMENTAL

A randomly allocated test site received narrowband ultraviolet B irradiation at twice the participant's minimal erythema dose. Beginning 24 hours after irradiation, the site received 2.5% mangosteen pericarp extract gel four times over 48 hours.

Drug: Topical Garcinia mangostana Pericarp Extract Gel 2.5%; Radiation: Narrowband Ultraviolet B Irradiation

Mangosteen Gel 5% After NB-UVB

EXPERIMENTAL

A randomly allocated test site received narrowband ultraviolet B irradiation at twice the participant's minimal erythema dose. Beginning 24 hours after irradiation, the site received 5% mangosteen pericarp extract gel four times over 48 hours.

Drug: Topical Garcinia mangostana Pericarp Extract Gel 5%; Radiation: Narrowband Ultraviolet B Irradiation

Mangosteen Gel 10% After NB-UVB

EXPERIMENTAL

A randomly allocated test site received narrowband ultraviolet B irradiation at twice the participant's minimal erythema dose. Beginning 24 hours after irradiation, the site received 10% mangosteen pericarp extract gel four times over 48 hours.

Drug: Topical Garcinia mangostana Pericarp Extract Gel 10%; Radiation: Narrowband Ultraviolet B Irradiation

Vehicle Gel After NB-UVB

PLACEBO COMPARATOR

A randomly allocated test site received narrowband ultraviolet B irradiation at twice the participant's minimal erythema dose. Beginning 24 hours after irradiation, the site received the hydrophilic vehicle gel without mangosteen extract four times over 48 hours.

Drug: Topical Vehicle Gel; Radiation: Narrowband Ultraviolet B Irradiation

NB-UVB-Only Control

ACTIVE COMPARATOR

A randomly allocated test site received narrowband ultraviolet B irradiation at twice the participant's minimal erythema dose without subsequent topical treatment.

Radiation: Narrowband Ultraviolet B Irradiation

Nonirradiated Untreated Control

NO INTERVENTION

A randomly allocated test site received neither narrowband ultraviolet B irradiation nor topical treatment.

Interventions

Topical Garcinia mangostana Pericarp Extract Gel 5% DRUG

A hydrophilic gel containing 5% ethanolic Garcinia mangostana L. pericarp extract was applied to a randomly allocated test site beginning 24 hours after narrowband ultraviolet B irradiation. The formulation was applied four times over 48 hours.

Mangosteen Gel 5% After NB-UVB

Topical Vehicle Gel DRUG

The hydrophilic gel vehicle, containing the same base formulation without Garcinia mangostana pericarp extract, was applied to a randomly allocated test site beginning 24 hours after narrowband ultraviolet B irradiation. The vehicle was applied four times over 48 hours.

Vehicle Gel After NB-UVB

Topical Garcinia mangostana Pericarp Extract Gel 2.5% DRUG

A hydrophilic gel containing 2.5% ethanolic Garcinia mangostana L. pericarp extract was applied to a randomly allocated test site beginning 24 hours after narrowband ultraviolet B irradiation. The formulation was applied four times over 48 hours.

Mangosteen Gel 2.5% After NB-UVB

Topical Garcinia mangostana Pericarp Extract Gel 10% DRUG

A hydrophilic gel containing 10% ethanolic Garcinia mangostana L. pericarp extract was applied to a randomly allocated test site beginning 24 hours after narrowband ultraviolet B irradiation. The formulation was applied four times over 48 hours.

Mangosteen Gel 10% After NB-UVB

Narrowband Ultraviolet B Irradiation RADIATION

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 vehicle site, and the untreated irradiated control site. A sixth untreated control site was not irradiated.

Mangosteen Gel 10% After NB-UVB; Mangosteen Gel 2.5% After NB-UVB; Mangosteen Gel 5% After NB-UVB; NB-UVB-Only Control; Vehicle Gel After NB-UVB

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 20-40 years. Fitzpatrick skin phototype IV. In good general health without an acute or chronic medical condition. Clinically normal back skin without erythema or pathological lesions at the proposed test sites.
• Able and willing to provide written informed consent.

You may not qualify if:

• History of atopic disease. Uneven pigmentation at the proposed test sites. Open wounds at the proposed test sites. Current use of topical or oral corticosteroids or antihistamines. History of photosensitivity or polymorphic light eruption. History of malignancy within the previous 5 years. Pregnancy or breastfeeding. Sunbathing or tanning-bed use within the previous 4 weeks. Known hypersensitivity to mangosteen or any component of the study gel.

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

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

Makassar, South Sulawesi, 90245, Indonesia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator performing the colorimetric assessments was unaware of the condition assigned to each test site. A separate investigator applied the formulations and retained the site-allocation list. Participants and the investigator applying the formulations were not masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Program Director, Department of Dermatology, Venereology, and Aesthetics

Model Details: This study used a randomized six-condition within-participant design. Each participant contributed six separate test sites and received all six study conditions concurrently, with one condition allocated to each site. Randomization occurred at the skin-site level rather than at the participant level. Each participant therefore served as their own control, and the six arms represent test-site conditions rather than independent groups of participants.

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: August 20, 2022
• Primary Completion: August 23, 2022
• Study Completion: August 23, 2022
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 3 months after publication and available for 5 years.
• Access Criteria: Qualified researchers with a methodologically sound proposal may submit a request to the corresponding author. Access will require approval by the investigators and Universitas Hasanuddin and execution of a data-use agreement.

Locations

ID (1)