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CompletedNCT07719413Updated Jul 31, 2026

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

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

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Jan 2025, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Human Volunteers With Fitzpatrick Skin Type III-V
  • Sunburn, Erythema

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03

In context

Sunburn

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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Lead sponsor

This is the only study on the registry with DOH - Tondo Medical Center as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Randomized Test Site on Back 1

    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

  • Experimental
    Randomized Test Site on Back 2

    Drug: Placebo gel · Drug: 2% cucumber seed gel · Drug: 4% cucumber seed gel

  • Placebo comparator
    Randomized Test Site on Back 3

    Drug: Placebo gel · Drug: 2% cucumber seed gel · Drug: 4% cucumber seed gel

Interventions

  • DrugPlacebo 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.

  • Drug2% cucumber seed gel

    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.

  • Drug4% cucumber seed gel

    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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

1 site
  • DOH-Tondo Medical Center Department of Dermatology and Venereology
    Manila, National Capital Region 1003, Philippines
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2025 to primary completion in Feb 2025, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2026
First posted
Jul 22, 2026
StartActual
Jan 27, 2025
Primary completionActual
Feb 26, 2025
CompletionActual
Feb 28, 2025
Last update
Jul 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07719413
Lead sponsor
DOH - Tondo Medical Center
Responsible party
Claudine Kay M. Fernandez (Principal Investigator, DOH - Tondo Medical Center) — Principal investigator
First posted
Jul 22, 2026
Start date
Jan 27, 2025
Primary completion
Feb 26, 2025
Completion
Feb 28, 2025
Last update
Jul 31, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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