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

Sun Damaged Skin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04181476
• Other study ID #: 13223
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 5, 2019
• Est. completion date: June 2022

Study information

• Verified date: January 2022
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: June 2022
• Est. primary completion date: January 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sun Damaged Skin

Intervention

Drug:
• Sunscreening Agents
Four different sunscreens

Locations

Country	Name	City	State
United States	Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	L'Oreal

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Investigator's Global Assessment (IGA)	Assesses erythema and pigmentation	through study completion, an average of 1 week
Primary	Change in Colorimetry	Measures erythema and pigmentation	through study completion, an average of 1 week
Primary	Change in Diffuse Reflectance Spectroscopy	Measures erythema and pigmentation	through study completion, an average of 1 week