Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The rationale of this study is to establish a robust method for assessing sun protection product efficacy in preventing erythema and tanning. Employing both artificial ultraviolet-A Irradiation and natural direct sunlight exposure, the investigation seeks to provide a reliable methodology, ensuring reproducibility and enabling a direct comparison between these methods. Meticulously determining optimal UV dosages, the study prioritizes inducing skin responses for evaluation while avoiding adverse effects like blistering. The localized validation of UV exposure techniques, tailored to the Indian population, contributes significantly to the field by addressing diverse skin types and environmental conditions. By incorporating both artificial and natural (direct sunlight) UV exposure methods, the study aspires to enhance the safety and effectiveness of future dermatological investigations, benefiting both the scientific community and the broader population.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Site T1 | Experimental | Test Product A - Test Sun Protection Cream Dosage Form - Cream Route of Administration - Topical Mode of Usage - Apply directly on the designated site till absorbed. Dosage - 0.2 mL/site |
|
| Site T2 | Active Comparator | Test Product B - Benchmark (Sun Protection Cream) Dosage Form - Cream Route of Administration - Topical Mode of Usage - Apply directly on the designated site till absorbed. Dosage - 0.2 mL/site |
|
| Site U1-4 | No Intervention | Test Product : No test product applied. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Sun Protection Cream | Other | Apply directly on the designated site till absorbed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Melanine index using instrumental assessment | Change in melanin index (MI) before and after the exposure as measured using the Changes in melanin index will be measured by using Mexameter® MX 18. | Days 1, 3 and 7. |
| Change in erythema index using instrumental assessment | Change in the erythema index (EI) before and after the exposure as measured using the Mexameter® MX 18. | Days 1, 3 and 7. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in skin erythema/dryness/wrinkles and oedema using draize scale | Visual change in skin erythema/dryness/wrinkles and oedema of the skin using the Draize scale. Where 0=No reaction, 4=severe erythema/wrinkle/oedema | Days 1, 3 and 7. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NovoBliss Research Pvt Ltd | Gandhinagar | Gujarat | 382421 | India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Proof of science/concept
Not provided
Not provided
Not provided
Not provided
| Benchmark Sun Protection Cream | Other | Apply directly on the designated site till absorbed. |
|
|
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided