An interventional study of Placebo gel and 2% cucumber seed gel in Healthy Human Volunteers With Fitzpatrick Skin Type III-V and Sunburn, Erythema, sponsored by DOH - Tondo Medical Center. Completed at 1 site in Philippines. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by DOH - Tondo Medical Center · Not applicable, Interventional, and Treatment
A monocentric, randomized, split-body, double-blind, controlled trial was conducted on 29 Filipino adults with Fitzpatrick skin types III-V. Topical 2% and 4% cucumber seed extract gels and placebo were applied to randomized sites on the lower back, followed by incremental narrow-band UVB exposure. MED was assessed 24 hours post-exposure. Repeated measures ANOVA and paired t-tests were used for statistical analysis.
29 studies on the registry are indexed under Sunburn; 2 are open to participants now.
This study's enrollment of 29 is below the median of 54 across 26 interventional studies indexed under Sunburn.
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- Filipinos aged 18 to 59 years with Fitzpatrick skin phototypes III to V were included in the study.
Exclusion Criteria:
Three test sites were delineated on each participant's lower back, and study treatments were randomly allocated to these sites using computer-generated randomization performed by a dermatology resident not involved in the trial. Three MED test patches were applied on three sun-protected areas on the lower back. The test patch had six windows of uniform sizes (2 cm × 2 cm) that were opened and exposed one at a time to incremental doses of excimer light. The gels were applied by the research assistant on the designated randomized areas on the lower back. The assistant researcher then applied the respective gels at an amount of 2 mg/cm2 (1/4 teaspoon) on each of the three test sites. Gels were massaged to the skin until fully absorbed.
Drug: Placebo gel · Drug: 2% cucumber seed gel · Drug: 4% cucumber seed gel
Drug: Placebo gel · Drug: 2% cucumber seed gel · Drug: 4% cucumber seed gel
Drug: Placebo gel · Drug: 2% cucumber seed gel · Drug: 4% cucumber seed gel
The placebo gel serves as the base formulation is composed of: the oil phase of the formulation comprising of octadecanol, stearic acid, and liquid paraffin, while the aqueous phase consisted of distilled water, glycerin, and ethylparaben. The two phases were emulsified and combined to make the base gel. The assistant researcher then applied placebo gel at an amount of 2 mg/cm2 (1/4 teaspoon) on the designated test site.
Cucumber seed gel preparations were compounded by an FDA-registered pharmaceutical company which were incorporated into the placebo base gel at 2% concentration. The assistant researcher then applied 2% cucumber seed gel at an amount of 2 mg/cm2 (1/4 teaspoon) on the designated randomized test site.
Cucumber seed gel preparations were compounded by an FDA-registered pharmaceutical company which were incorporated into the placebo base gel at 4% concentration. The assistant researcher then applied 4% cucumber seed gel at an amount of 2 mg/cm2 (1/4 teaspoon) on the designated randomized test site.
Change in minimal erythema dose (MED) after application of 2% and 4% cucumber seed extract compared with placebo
After 24 hours post-application, the principal investigator examined previously irradiated sites. A well-defined erythematous response at the lowest NBUVB dose was recorded as the MED, corresponding to E2 on the Visual Erythema Scale.
Time frame: 24 hours post application
Adverse events such as pain, pruritus, tenderness, burning, blistering, or irregular pigmentation (Composite secondary outcome)
Participants were also assessed after 24 and 48 hours regarding any experience of adverse events such as, but not limited to, pruritus, pain, tenderness, blistering, or irregular pigmentation immediately after and then 24 and 48 hours after application of gels.
Time frame: 24 and 48 hours after application
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All de-identified individual participant data might be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: From: At the end of the study End: No end date
Ran from Jan 2025 to primary completion in Feb 2025, 0 months.
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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