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

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.

Study Overview

• Status: Completed
• Conditions: Skin Pigmentation
• Intervention / Treatment: Other: Test Sun Protection Cream; Other: Benchmark Sun Protection Cream

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Gandhinagar, Gujarat, India, 382421
      • NovoBliss Research Pvt Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 06 Healthy adult subjects aged between 18 to 45 years (both inclusive).
2. Healthy adult male and non-pregnant|non-lactating females.
3. Female of childbearing potential have self-reported negative urine pregnancy test.
4. Subjects with Fitzpatrick skin types III to V will be included. Alternatively, subjects with a Skin colorimetric Individual Typology Angle (ITA) value ranging from 20° to 41° at the application site (forearms) to be included to ensure a diverse representation of skin tones.
5. Absence of known photosensitivity disorders to maintain the integrity of the study outcomes.
6. Subjects must exhibit a willingness to comply with study plan, including follow-up visits and product applications.
7. No history of skin cancer to or any adverse skin conditions, and not under any medication(s) likely to interfere with the study results.
8. Subjects willing to follow study direction and willing to give written informed consent for the participation.

Exclusion Criteria:

1. Active skin diseases, such as eczema or psoriasis, that could potentially influence skin reactions.
2. Use of photosensitizing medications that interfere with UV-induced skin responses.
3. Pregnancy or breastfeeding status, as hormonal changes during these periods can affect skin reactions.
4. Individuals with a history of severe adverse reactions to skincare or cosmetic products, ensuring participant safety.
5. Presence of open wounds, infections, or cuts at the application sites to prevent complications during the study.
6. Subjects with a history of significant sunburns in the past three months, minimizing the potential for confounding effects.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Site T1; 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	Other: Test Sun Protection Cream; Apply directly on the designated site till absorbed.; Other Names: Test Treatment A
Active Comparator: Site T2; 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	Other: Benchmark Sun Protection Cream; Apply directly on the designated site till absorbed.; Other Names: Test Treatment B
No Intervention: Site U1-4; Test Product : No test product applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: NovoBliss Research Pvt Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Actual): March 13, 2024
• Study Completion (Actual): March 13, 2024

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NB240005-NB-V

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No