Efficacy Evaluation of Products Against Long Wavelength Ultraviolet A1 and Visible Light Induced Biological Effects

Phase 2

Active, not recruiting

• Conditions: Sun Damaged Skin
• Interventions: Drug: Sunscreening Agents

• Registration Number: NCT04181476
• Lead Sponsor: Henry Ford Health System

Brief Summary

The purpose of this study is to evaluate the efficacy of topical products in providing protection against the visible light and ultraviolet A1 (UVA1) part of sunlight. Ultraviolet radiation and visible light are both components of sunlight that reach the earth. It is important to test these topical products against visible light and UVA1 because our current sunscreens may not protect against these very well.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-23
• Study Start: 2019-11-05
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-29
• Primary Completion: 2021-01-18
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-01-28
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Patient age 18 and older
• Patients Fitzpatrick skin phototype (SPT) III-IV with normal skin health
• Patient able to understand requirements of the study and risks involved

Exclusion Criteria

• A recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
• A history of a relevant skin condition on any part of the patient's body (e.g. atopic dermatitis, eczema, vitiligo, sun burn, etc.
• A known history of photodermatoses
• A known history of photosensitivity disorders
• A known history of melanoma or non-melanoma skin cancers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topical products and Untreated areas	Sunscreening Agents	The subject will serve as their own control. Four different products will be tested.

Primary Outcome Measures

Name	Time	Method
Change in Diffuse Reflectance Spectroscopy	through study completion, an average of 1 week	Measures erythema and pigmentation
Change in Investigator's Global Assessment (IGA)	through study completion, an average of 1 week	Assesses erythema and pigmentation
Change in Colorimetry	through study completion, an average of 1 week	Measures erythema and pigmentation

Trial Locations

Locations (1)

Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,; 🇺🇸 Detroit, Michigan, United States