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Narrowband Ultraviolet B-Induced Skin ErythemaPhase 2NCT07849842

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

A Phase 2 study testing Topical Garcinia mangostana Pericarp Extract Gel 2.5%, Topical Garcinia mangostana Pericarp Extract Gel 5% and Topical Garcinia mangostana Pericarp Extract Gel 10% in people with Narrowband Ultraviolet B-Induced Skin Erythema and Erythema, run by Hasanuddin University at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 40 yearsHealthy volunteers can take part
What is being tested?
Topical Garcinia mangostana Pericarp Extract Gel 2.5%, Topical Garcinia mangostana Pericarp Extract Gel 5% and Topical Garcinia mangostana Pericarp Extract Gel 10%
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteIndonesia
Study dates
20 Aug 2022to 23 Nov 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Adults aged 20-40 years
  • Fitzpatrick skin phototype IV or V
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Pregnancy or breastfeeding
  • Sunbathing or tanning-bed use within the previous 4 weeks
  • Known hypersensitivity to mangosteen or any component of the study gel

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • Department of Dermatology, Venereology, and Aesthetics, Faculty of Medicine, Universitas Hasanuddin

    Makassar, South Sulawesi, 90245

Other trials in Indonesia

About this study

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

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:

Read more
  • 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
Read the detailed description

This was a single-center, randomized, double-blind, placebo-controlled, within-person trial conducted at the Department of Dermatology, Venereology, and Aesthetics, Hasanuddin University, Makassar, Indonesia, between August and November 2022. It used a modified ultraviolet erythema test in which treatment started only after erythema had developed, so that the effect of the gel on the resolution of established erythema could be separated from any ultraviolet-filtering effect.

Each participant had six 1.9 × 1.9-cm test sites on the upper back. The six conditions (2.5%, 5%, and 10% mangosteen pericarp extract gel, placebo gel, irradiated untreated, and nonirradiated untreated) were allocated to the sites with a six-sequence Williams design, so that each condition appeared equally often at each anatomical position. Sequences were generated by an independent statistician and concealed in opaque, sequentially numbered envelopes.

The minimal erythema dose (MED) was determined with a narrowband UVB unit (peak 311 nm). Five sites were irradiated with twice the individual MED, and the sixth site was shielded. No product was on the skin during irradiation. From 24 h after irradiation (Day 1), approximately 10 mg of the assigned product (2.77 mg/cm²) was applied at 08:00 and 16:00 on Days 1 and 2. Final assessment took place on Day 3 before any further application.

The extract was prepared by maceration of authenticated mangosteen pericarp in 96% ethanol and standardized spectrophotometrically as total UV-absorbing xanthones (α-mangostin equivalents). Active gels contained 2.5%, 5%, or 10% (w/w) extract in a hydrophilic carbomer-based gel. The placebo contained the same excipients with 0.02% (w/w) brown iron oxide to match the color of the active gel. Products were dispensed in identical tubes labeled only with a site code. Participants, the product applicator, and outcome assessors were blinded to allocation.

Skin color was measured in the CIELAB color space with a calibrated chromameter (Konica Minolta CR-400) after 30 min of acclimatization; three readings per site were averaged. The nonirradiated site served as a concurrent reference. Data were analyzed with linear mixed models with participant as a random factor, and pairwise comparisons were Bonferroni-adjusted.

The trial was approved by the Health Research Ethics Committee, Faculty of Medicine, Hasanuddin University (approval no. 336/UN4.6.4.5.31/PP36/2022). This record was registered retrospectively.

Being tested
Topical Garcinia mangostana Pericarp Extract Gel 2.5%, Topical Garcinia mangostana Pericarp Extract Gel 5%, Topical Garcinia mangostana Pericarp Extract Gel 10%, Topical Placebo Gel, Narrowband Ultraviolet B Irradiation
Keywords
Mangosteen, Garcinia mangostana, Narrowband ultraviolet B, Topical gel, skin phototype, uv erythema test, xanthones, within-person design
Medical subject headings
Erythema, Sunburn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Topical Garcinia mangostana Pericarp Extract Gel 2.5%Drug

    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.

  • Topical Garcinia mangostana Pericarp Extract Gel 5%Drug

    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.

  • Topical Garcinia mangostana Pericarp Extract Gel 10%Drug

    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.

  • Topical Placebo GelDrug

    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.

  • Narrowband Ultraviolet B IrradiationRadiation

    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.

Study groups in NCT07849842
Study groupRoleWhat they receive
Mangosteen Gel 2.5% After NB-UVBExperimentalA 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 at 08:00 and 16:00 on Days 1 and 2 (four applications).
Receives: Drug: Topical Garcinia mangostana Pericarp Extract Gel 2.5%; Radiation: Narrowband Ultraviolet B Irradiation
Mangosteen Gel 5% After NB-UVBExperimentalA 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 at 08:00 and 16:00 on Days 1 and 2 (four applications).
Receives: Drug: Topical Garcinia mangostana Pericarp Extract Gel 5%; Radiation: Narrowband Ultraviolet B Irradiation
Mangosteen Gel 10% After NB-UVBExperimentalA 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 at 08:00 and 16:00 on Days 1 and 2 (four applications).
Receives: Drug: Topical Garcinia mangostana Pericarp Extract Gel 10%; Radiation: Narrowband Ultraviolet B Irradiation
Placebo Gel After NB-UVBPlacebo comparatorA 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 placebo gel at 08:00 and 16:00 on Days 1 and 2 (four applications).
Receives: Drug: Topical Placebo Gel; Radiation: Narrowband Ultraviolet B Irradiation
Irradiated Untreated ControlOtherA randomly allocated test site received narrowband ultraviolet B irradiation at twice the participant's minimal erythema dose without subsequent topical treatment.
Receives: Radiation: Narrowband Ultraviolet B Irradiation
Nonirradiated Untreated ControlNo interventionA randomly allocated test site received neither narrowband ultraviolet B irradiation nor topical treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Skin Redness (Chromameter a* Value) From Day 1 to Day 3

    Skin redness was measured in the CIELAB color space with a calibrated chromameter (Konica Minolta CR-400, 8-mm aperture) after 30 minutes of acclimatization; three readings per site were averaged. The outcome is the reduction in a* (Day 1 minus Day 3) at each test site. Day 1 was 24 hours after irradiation, before the first application. A larger reduction indicates faster resolution of erythema.

    Measured: Day 1 (24 hours after irradiation, before the first application) and Day 3 (after four applications)

Secondary outcomes (2)
  1. Concentration Dependence of the Change in Skin Redness (Chromameter a* Value)

    Comparison of the Day 1-to-Day 3 reduction in a* among the 2.5%, 5%, and 10% mangosteen pericarp extract gel sites, measured as described for the primary outcome.

    Measured: Day 1 to Day 3

  2. Number of Participants With Local Adverse Skin Reactions

    Burning, stinging, pruritus, contact dermatitis, vesiculation, edema, and other local reactions at each treated site, assessed by investigators at each visit.

    Measured: Day 1 to Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2026
  2. Study start20 Aug 2022
  3. Primary completion23 Nov 2022
  4. Study completion23 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Within-person (split-body) design. Each participant received all six conditions simultaneously at six test sites on the upper back: 2.5%, 5%, and 10% mangosteen pericarp extract gel, placebo gel, irradiated untreated, and nonirradiated untreated. Conditions were allocated to sites with a six-sequence Williams design so that each condition appeared equally often at each anatomical position. There were no treatment periods or washout; the crossover model was selected because every participant received every condition.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07849842
Sponsor's protocol ID
UH22030115
Other IDs
336/UN4.6.4.5.31/PP36/2022
Status last verified
Oct 2026
First submitted
24 Sep 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual participant data underlying the reported results, together with the data dictionary and statistical analysis code, will be available upon reasonable request, subject to institutional and ethical approval and execution of an appropriate data-use agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Topical Garcinia mangostana Pericarp Extract Gel 2.5%, Topical Garcinia mangostana Pericarp Extract Gel 5% and Topical Garcinia mangostana Pericarp Extract Gel 10% in people with Narrowband Ultraviolet B-Induced Skin Erythema and Erythema, run by Hasanuddin University at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Skin Redness (Chromameter a* Value) From Day 1 to Day 3 (time frame: Day 1 (24 hours after irradiation, before the first application) and Day 3 (after four applications)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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