NCT06384092

Process Validation in Dermatology: Assessing Methods for UV Exposure (Artificial Source vs. Sunlight) and Efficacy Evaluation of Anti-Tanning Agents

Standardization of UV Exposure Methods (Artificial Source vs. Sunlight) in Dermatological Research: A Comprehensive Investigation Into the Efficacy Assessment Methodology for Anti-tanning Agents Through Process Validation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Skin Pigmentation

Interventions

Type	Name	Description
OTHER	Test Sun Protection Cream	Apply directly on the designated site till absorbed.
OTHER	Benchmark Sun Protection Cream	Apply directly on the designated site till absorbed.

Timeline

• Start date: 2024-03-07
• Primary completion: 2024-03-13
• Completion: 2024-03-13
• First posted: 2024-04-25
• Last updated: 2024-04-29

Locations

1 site across 1 country: India