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Completed

NCT Number: NCT07719413

A Clinical Trial to Compare the Photoprotective Effects of Cucumber Seed Extract vs Placebo in Filipino Adults by Measurement of Minimal Erythema Dose

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.

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Key information

Conditions

Healthy Human Volunteers With Fitzpatrick Skin Type III-V Burns Erythema Pathological Conditions, Signs and Symptoms Photosensitivity Disorders Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Sunburn Sunburn, Erythema Wounds and Injuries

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DOH-Tondo Medical Center Department of Dermatology and Venereology

Manila, National Capital Region, 1003, Philippines

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo Gel

Drug

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.

2% cucumber seed gel

Drug

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.

4% cucumber seed gel

Drug

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.

Primary outcomes

  1. Change in minimal erythema dose (MED) after application of 2% and 4% cucumber seed extract compared with placebo

    Time frame: 24 hours post application

    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.

Secondary outcomes

  1. Adverse events such as pain, pruritus, tenderness, burning, blistering, or irregular pigmentation (Composite secondary outcome)

    Time frame: 24 and 48 hours after application

    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.

Sponsors and collaborators

Lead sponsor

DOH - Tondo Medical Center

Other Gov

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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