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

NCT06384092 | Completed

• 1 other identifier: NB240005-NB-V
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in skin erythema/dryness/wrinkles and oedema using draize scale

  Days 1, 3 and 7.

Study Arms (3)

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

Other: Test Sun Protection Cream

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

Other: Benchmark Sun Protection Cream

Site U1-4

NO INTERVENTION

Test Product : No test product applied.

Interventions

Test Sun Protection Cream OTHER

Apply directly on the designated site till absorbed.

Also known as: Test Treatment A

Site T1

Benchmark Sun Protection Cream OTHER

Apply directly on the designated site till absorbed.

Also known as: Test Treatment B

Site T2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult subjects aged between 18 to 45 years (both inclusive).
• Healthy adult male and non-pregnant\|non-lactating females.
• Female of childbearing potential have self-reported negative urine pregnancy test.
• 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.
• Absence of known photosensitivity disorders to maintain the integrity of the study outcomes.
• Subjects must exhibit a willingness to comply with study plan, including follow-up visits and product applications.
• No history of skin cancer to or any adverse skin conditions, and not under any medication(s) likely to interfere with the study results.
• Subjects willing to follow study direction and willing to give written informed consent for the participation.

You may not qualify if:

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

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead

Study Sites (1)

NovoBliss Research Pvt Ltd

Gandhinagar, Gujarat, 382421, India

Location

MeSH Terms

Conditions

Pigmentation Disorders

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Director (Operations)

Model Details: Proof of science/concept

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: April 25, 2024
• Study Start: March 7, 2024
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)