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

NCT04181476 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 13223
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Sun Damaged Skin

Outcome Measures

Primary Outcomes (3)

• Change in Investigator's Global Assessment (IGA)

  Assesses erythema and pigmentation

  through study completion, an average of 1 week

• Change in Colorimetry

  Measures erythema and pigmentation

  through study completion, an average of 1 week

• Change in Diffuse Reflectance Spectroscopy

  Measures erythema and pigmentation

  through study completion, an average of 1 week

Study Arms (1)

Topical products and Untreated areas

OTHER

The subject will serve as their own control. Four different products will be tested.

Drug: Sunscreening Agents

Interventions

Sunscreening Agents DRUG

Four different sunscreens

Topical products and Untreated areas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead
• L'Oreal: collaborator

Study Sites (1)

Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Interventions

Sunscreening Agents

Intervention Hierarchy (Ancestors)

Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals

Study Officials

• Iltefat Hamzavi, MD

  Henry Ford HS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff Physician, Director of Investigator-Initiated Trials

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: November 29, 2019
• Study Start: November 5, 2019
• Primary Completion: January 18, 2021
• Study Completion: June 1, 2022
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)