AzTrials
AzTrials

Ultraviolet B-Induced Skin ErythemaNCT07849829

Mangosteen Gel Applied Before NB-UVB Exposure in Healthy Adults

A study testing Topical Garcinia mangostana Pericarp Extract Gel 5%, Topical Garcinia mangostana Pericarp Extract Gel 10% and Topical Garcinia mangostana Pericarp Extract Gel 20% in people with Ultraviolet B-Induced Skin 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
Search all trials

Trial summary

This study examined whether a gel containing mangosteen (*Garcinia mangostana*) pericarp extract could reduce short-term skin redness caused by narrowband ultraviolet B (NB-UVB) exposure when applied before irradiation. Healthy adults aged 20-45 years with Fitzpatrick skin phototype III or IV participated. Read more about this study

Who is it for?
Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Ultraviolet B-Induced Skin Erythema
What is being tested?
Topical Garcinia mangostana Pericarp Extract Gel 5%, Topical Garcinia mangostana Pericarp Extract Gel 10% and Topical Garcinia mangostana Pericarp Extract Gel 20%
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
1 siteIndonesia
Study dates
26 Sep 2019to 26 Nov 2019
Phase
Interventional
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Adults aged 20-45 years. Fitzpatrick skin phototype III or 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.

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 systemic corticosteroids or antihistamines. History of photosensitivity or polymorphic light eruption. History of malignancy within the previous 5 years. Pregnancy or breastfeeding. Sunbathing or use of a tanning bed 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: Effect of Topical Garcinia Mangostana Pericarp Extract Gel Applied Before Narrowband Ultraviolet B Exposure on Skin Redness in Healthy Adults: A Randomized, Single-Blind, Within-Person Study

This study examined whether a gel containing mangosteen (*Garcinia mangostana*) pericarp extract could reduce short-term skin redness caused by narrowband ultraviolet B (NB-UVB) exposure when applied before irradiation.

Healthy adults aged 20-45 years with Fitzpatrick skin phototype III or IV participated. Six small test sites were marked on each participant's back. Each site was assigned to one of six conditions: mangosteen gel containing 5%, 10%, or 20% extract; gel base without extract; NB-UVB exposure without topical treatment; or no topical treatment and no NB-UVB exposure. Because all six conditions were evaluated in the same participant, each participant served as their own control.

The active gels and gel base were applied 20 minutes before NB-UVB exposure. The ultraviolet dose was based on each participant's individual skin sensitivity. Skin redness and lightness were measured with a color-measuring instrument before exposure and at 12, 24, and 48 hours afterward. The investigator performing the skin-color measurements was not informed which condition had been assigned to each test site.

Read the detailed description

This was a single-center, randomized, outcome-assessor-blinded, within-participant controlled photoprovocation study in healthy adults. The study evaluated the effect of topical gel formulations containing 5%, 10%, or 20% ethanolic *Garcinia mangostana* pericarp extract on the early skin-color response to narrowband ultraviolet B exposure.

Six adjacent 1.9 × 1.9 cm test sites were identified on clinically normal skin of each participant's back. The six study conditions were allocated among the test sites within each participant: 5% mangosteen gel plus NB-UVB, 10% mangosteen gel plus NB-UVB, 20% mangosteen gel plus NB-UVB, vehicle gel plus NB-UVB, irradiated untreated control, and nonirradiated untreated control.

Before the experimental exposure, each participant's minimal erythema dose was determined. Approximately 10 mg of the assigned active gel or vehicle, corresponding to approximately 2.77 mg/cm², was applied to the relevant test site 20 minutes before irradiation. The active-gel, vehicle-treated, and irradiated untreated sites were exposed to narrowband UVB at twice the participant's individual minimal erythema dose. The nonirradiated untreated site received neither topical preparation nor NB-UVB exposure.

Skin color was assessed using a Konica Minolta CR-400 chromameter before irradiation and at 12, 24, and 48 hours after exposure. Three measurements were obtained from each test site at each assessment. The a* coordinate was used to quantify change in skin redness, and the L* coordinate was used to assess change in skin lightness. The principal comparison evaluated differences in change in a* among the active formulations, vehicle-treated irradiated skin, and untreated irradiated skin. Change in L* was evaluated as a secondary colorimetric outcome. The investigator performing the colorimetric assessments was unaware of the condition assigned to each test site. Local tolerability and adverse events were monitored throughout the study.

Being tested
Topical Garcinia mangostana Pericarp Extract Gel 5%, Topical Garcinia mangostana Pericarp Extract Gel 10%, Topical Garcinia mangostana Pericarp Extract Gel 20%, Topical Vehicle Gel, Narrowband Ultraviolet B Irradiation
Keywords
Garcinia mangostana, Mangosteen Pericarp Extract, Narrowband Ultraviolet B, UVB Photoprovocation, Skin Erythema, Skin Redness, Reflectance Colorimetry
Medical subject headings
Erythema

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 5%Drug

    A hydrophilic gel containing 5% ethanolic Garcinia mangostana L. pericarp extract was applied once to a randomly allocated 1.9 × 1.9-cm test site on the participant's back at a dose of 10 mg per site (approximately 2.77 mg/cm²). The gel was applied 20 minutes before narrowband ultraviolet B irradiation at twice the participant's individually determined minimal erythema dose.

  • Topical Garcinia mangostana Pericarp Extract Gel 10%Drug

    A hydrophilic gel containing 10% ethanolic Garcinia mangostana L. pericarp extract was applied once to a randomly allocated 1.9 × 1.9-cm test site on the participant's back at a dose of 10 mg per site (approximately 2.77 mg/cm²). The gel was applied 20 minutes before narrowband ultraviolet B irradiation at twice the participant's individually determined minimal erythema dose.

  • Topical Garcinia mangostana Pericarp Extract Gel 20%Drug

    A hydrophilic gel containing 20% ethanolic Garcinia mangostana L. pericarp extract was applied once to a randomly allocated 1.9 × 1.9-cm test site on the participant's back at a dose of 10 mg per site (approximately 2.77 mg/cm²). The gel was applied 20 minutes before narrowband ultraviolet B irradiation at twice the participant's individually determined minimal erythema dose.

  • Topical Vehicle GelDrug

    The hydrophilic gel vehicle, containing the same base formulation but no Garcinia mangostana pericarp extract, was applied once to a randomly allocated 1.9 × 1.9-cm test site at a dose of 10 mg per site (approximately 2.77 mg/cm²). The vehicle was applied 20 minutes before narrowband ultraviolet B irradiation at twice the participant's individually determined minimal erythema dose.

  • 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-gel sites, the vehicle-treated site, and one untreated irradiated control site. A sixth untreated control site was not irradiated.

Study groups in NCT07849829
Study groupRoleWhat they receive
Mangosteen Gel 5% Plus NB-UVBExperimentalA randomly allocated test site received 5% mangosteen pericarp extract gel 20 minutes before narrowband ultraviolet B irradiation at twice the participant's minimal erythema dose.
Receives: Drug: Topical Garcinia mangostana Pericarp Extract Gel 5%; Radiation: Narrowband Ultraviolet B Irradiation
Mangosteen Gel 10% Plus NB-UVBExperimentalA randomly allocated test site received 10% mangosteen pericarp extract gel 20 minutes before narrowband ultraviolet B irradiation at twice the participant's minimal erythema dose.
Receives: Drug: Topical Garcinia mangostana Pericarp Extract Gel 10%; Radiation: Narrowband Ultraviolet B Irradiation
Mangosteen Gel 20% Plus NB-UVBExperimentalA randomly allocated test site received 20% mangosteen pericarp extract gel 20 minutes before narrowband ultraviolet B irradiation at twice the participant's minimal erythema dose.
Receives: Drug: Topical Garcinia mangostana Pericarp Extract Gel 20%; Radiation: Narrowband Ultraviolet B Irradiation
Vehicle Gel Plus NB-UVBPlacebo comparatorA randomly allocated test site received the hydrophilic vehicle gel without mangosteen extract 20 minutes before narrowband ultraviolet B irradiation at twice the participant's minimal erythema dose.
Receives: Drug: Topical Vehicle Gel; Radiation: Narrowband Ultraviolet B Irradiation
NB-UVB-Only ControlActive comparatorA randomly allocated test site received narrowband ultraviolet B irradiation at twice the participant's minimal erythema dose without topical treatment.
Receives: Radiation: Narrowband Ultraviolet B Irradiation
Nonirradiated Untreated ControlNo interventionA randomly allocated test site received neither topical treatment nor narrowband ultraviolet B irradiation.

What is being measured

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

  1. Change From Baseline in Skin Redness Assessed by the CIELAB a* Coordinate

    Skin redness was measured using a calibrated CR-400 chromameter (Konica Minolta, Japan). Three consecutive measurements were obtained at each test site and averaged. Change in redness was calculated as Δa* = post-exposure a* minus baseline a*. Higher positive Δa* values indicate a greater increase in skin redness. Changes were compared across the three mangosteen gel sites, vehicle-treated irradiated site, untreated irradiated site, and nonirradiated untreated site within each participant.

    Measured: Baseline and 12, 24, and 48 hours after narrowband ultraviolet B exposure

Secondary outcomes (1)
  1. Change From Baseline in Skin Lightness Assessed by the CIELAB L* Coordinate

    Skin lightness was measured using a calibrated CR-400 chromameter (Konica Minolta, Japan). Three consecutive measurements were obtained at each test site and averaged. Change in skin lightness was calculated as ΔL* = baseline L* minus post-exposure L*. Higher positive ΔL* values indicate a greater reduction in skin lightness. Changes were compared across the six study conditions within each participant.

    Measured: Baseline and 12, 24, and 48 hours after narrowband ultraviolet B exposure

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 start26 Sep 2019
  3. Primary completion26 Nov 2019
  4. Study completion26 Nov 2019

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study used a randomized six-condition within-participant design. Each participant contributed six separate test sites on the back and received all six study conditions concurrently, with one condition assigned to each site. Randomization was performed 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 separate groups of participants.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07849829
Sponsor's protocol ID
UH19060112
Status last verified
Sep 2026
First submitted
24 Sep 2026
Last updated
30 Sep 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 results reported in the publication, together with the data dictionary and statistical analysis code, will be available upon reasonable request. Data sharing will be subject to institutional and ethical approval and execution of an appropriate data-use agreement. No directly identifying participant information will be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Topical Garcinia mangostana Pericarp Extract Gel 5%, Topical Garcinia mangostana Pericarp Extract Gel 10% and Topical Garcinia mangostana Pericarp Extract Gel 20% in people with Ultraviolet B-Induced Skin 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 2 inclusion and 1 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 30 Sep 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.

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 From Baseline in Skin Redness Assessed by the CIELAB a* Coordinate (time frame: Baseline and 12, 24, and 48 hours after narrowband ultraviolet B exposure). 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 30 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in