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NCT07719413

Overview

NCT ID: NCT07719413
Lead Sponsor: DOH - Tondo Medical CenterOTHER_GOV
Official Title: A Double-blind Randomized Controlled Trial on the Photoprotective Effect of Cucumber (Cucumis Sativus) Seed Extract vs Placebo in Terms of Minimal Erythema Dose Among Filipino Adults
Brief Summary: 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.
Conditions: Healthy Human Volunteers With Fitzpatrick Skin Type III-V
Sunburn, Erythema

Status and Timeline

Status: Completed
Last Update Posted: Jul 31, 2026Actual
Start Date: Jan 27, 2025Actual
Primary Completion Date: Feb 26, 2025Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

- Filipinos aged 18 to 59 years with Fitzpatrick skin phototypes III to V were included in the study.

Exclusion Criteria:

Elderly and pediatric populations were excluded due to differences in skin structure, immune responses, and the presence of age-related comorbidities that may confound study findings.

Additional exclusions applied to individuals who were pregnant or breastfeeding;

Had a history of phototoxic, photoallergic, or abnormal responses to sunlight; ----Reported allergies to cosmetic products, sunscreens, topical drugs, cucumber, or any study formulation component

Participants were also excluded if they presented with pre-existing or dormant dermatologic conditions, sunburn, suntan, scars, active lesions, or uneven pigmentation on the lower back.

Other exclusion criteria included current or recent use of medications known to cause hyperpigmentation (e.g., minocycline, clofazimine, amiodarone, antimalarials, chemotherapeutic agents), systemic treatments affecting skin status within the past 15-30 days, sun exposure of the lower back within four weeks prior to inclusion, or intake of skin-whitening supplements such as glutathione within one month before the study.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 29Actual
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: No data available
Locations: DOH-Tondo Medical Center Department of Dermatology and Venereology

Similar Studies

Participant Group/Arms

Randomized Test Site on Back 1Experimental

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

Randomized Test Site on Back 2Experimental

Drug: Placebo gel

Drug: 2% cucumber seed gel

Randomized Test Site on Back 3Placebo Comparator

Drug: Placebo gel

Drug: 2% cucumber seed gel