Healthy Human Volunteers With Fitzpatrick Skin Type III-V, Sunburn, Erythema
Conditions
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.
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.
Sponsors
DOH - Tondo Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in minimal erythema dose (MED) after application of 2% and 4% cucumber seed extract compared with placebo | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse events such as pain, pruritus, tenderness, burning, blistering, or irregular pigmentation (Composite secondary outcome) | 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. |
Countries
Philippines
Outcome results
None listed