Healthy Human Volunteers With Fitzpatrick Skin Type III-VNCT07719413
A Clinical Trial to Compare the Photoprotective Effects of Cucumber Seed Extract vs Placebo in Filipino Adults by Measurement of Minimal Erythema Dose
A study testing 2% cucumber seed gel and 4% cucumber seed gel in people with Healthy Human Volunteers With Fitzpatrick Skin Type III-V and Sunburn, Erythema, run by DOH - Tondo Medical Center at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Human Volunteers With Fitzpatrick Skin Type III-V, Sunburn, Erythema
- What is being tested?
- 2% cucumber seed gel and 4% cucumber seed gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 sitePhilippines
- Study dates
- 27 Jan 2025to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Filipinos aged 18 to 59 years with Fitzpatrick skin phototypes III to V were included in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Philippines1 site
DOH-Tondo Medical Center Department of Dermatology and Venereology
Manila, National Capital Region, 1003
About this study
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
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.
- Being tested
- Placebo gel, 2% cucumber seed gel, 4% cucumber seed gel
- Medical subject headings
- Sunburn, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo gelDrug
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 gelDrug
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 gelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Randomized Test Site on Back 1 | Experimental | 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. Receives: Drug: Placebo gel; Drug: 2% cucumber seed gel; Drug: 4% cucumber seed gel |
| Randomized Test Site on Back 2 | Experimental | Not described Receives: Drug: Placebo gel; Drug: 2% cucumber seed gel; Drug: 4% cucumber seed gel |
| Randomized Test Site on Back 3 | Placebo comparator | Not described Receives: Drug: Placebo gel; Drug: 2% cucumber seed gel; Drug: 4% cucumber seed gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 and 48 hours after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start27 Jan 2025
- Primary completion26 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Human Volunteers With Fitzpatrick Skin Type III-VStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- DOH - Tondo Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Claudine Kay M. Fernandez, DOH - Tondo Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719413
- Sponsor's protocol ID
- REC-2024-00086
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified individual participant data might be shared.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07719413
- Acronym / sponsor ID
- REC-2024-00086
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- DOH - Tondo Medical CenterOther government
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Randomized Test Site on Back 1 | Experimental | Drug: Placebo gel, Drug: 2% cucumber seed gel, Drug: 4% cucumber seed gelThree 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. |
| Randomized Test Site on Back 2 | Experimental | Drug: Placebo gel, Drug: 2% cucumber seed gel, Drug: 4% cucumber seed gel |
| Randomized Test Site on Back 3 | Placebo comparator | Drug: Placebo gel, Drug: 2% cucumber seed gel, Drug: 4% cucumber seed gel |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Filipinos aged 18 to 59 years with Fitzpatrick skin phototypes III to V were included in the study.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo gelThe 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. | Drug | Randomized Test Site on Back 1, Randomized Test Site on Back 2, Randomized Test Site on Back 3 |
| 2% cucumber seed gelCucumber 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. | Drug | Randomized Test Site on Back 1, Randomized Test Site on Back 2, Randomized Test Site on Back 3 |
| 4% cucumber seed gelCucumber 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. | Drug | Randomized Test Site on Back 1, Randomized Test Site on Back 2, Randomized Test Site on Back 3 |
Primary outcome
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.
1 secondary outcome
Adverse events such as pain, pruritus, tenderness, burning, blistering, or irregular pigmentation (Composite secondary outcome)
Time frame: 24 and 48 hours after application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Yes. All de-identified individual participant data might be shared.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% cucumber seed gel and 4% cucumber seed gel in people with Healthy Human Volunteers With Fitzpatrick Skin Type III-V and Sunburn, Erythema, run by DOH - Tondo Medical Center at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in minimal erythema dose (MED) after application of 2% and 4% cucumber seed extract compared with placebo (time frame: 24 hours post application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.