Narrowband Ultraviolet B-Induced Skin Erythema, Erythema, Sunburn, Erythema
Conditions
Keywords
Mangosteen, Garcinia mangostana, Narrowband ultraviolet B, Topical gel, skin phototype, uv erythema test, xanthones, within-person design
Brief 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
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.
Interventions
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.
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.
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.
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 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.
Sponsors
Study design
Masking description
Products were filled into identical white tubes labeled only with a site code by a pharmacist not otherwise involved in the trial. The placebo contained 0.02% brown iron oxide to match the color of the active gel. The person applying the products (care provider) and the outcome assessors were unaware of the allocation. The two untreated conditions could not be masked.
Intervention 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.
Eligibility
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skin Redness (Chromameter a* Value) From Day 1 to Day 3 | Day 1 (24 hours after irradiation, before the first application) and Day 3 (after four applications) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration Dependence of the Change in Skin Redness (Chromameter a* Value) | Day 1 to Day 3 | 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. |
| Number of Participants With Local Adverse Skin Reactions | Day 1 to Day 3 | Burning, stinging, pruritus, contact dermatitis, vesiculation, edema, and other local reactions at each treated site, assessed by investigators at each visit. |
Countries
Indonesia