Efficacy Evaluation of Products Against Long Wavelength U... | NCT04181476

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

NCT04181476

Sponsor

Henry Ford Health System

Status

Active, not recruiting

Last Update Posted

Jan 28, 2022Actual

Enrollment

12Actual

Phase

Phase 2

Conditions

Sun Damaged Skin

Interventions

Sunscreening Agents

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2019Actual

Primary Completion Date

Jan 18, 2021Actual

Completion Date

Jun 2022Estimated

First Submitted Date

Oct 23, 2019

First Submission Date that Met QC Criteria

Nov 26, 2019

First Posted Date

Nov 29, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2022

Last Update Posted Date

Jan 28, 2022Actual

Name	Class
L'Oreal	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Topical products and Untreated areas	Other	The subject will serve as their own control. Four different products will be tested.	Drug: Sunscreening Agents

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sunscreening Agents	Drug	Four different sunscreens	Topical products and Untreated areas

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Iltefat Hamzavi, MD	Henry Ford HS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,		Detroit	Michigan	48202	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Submission Tracking

Estimated Results First Submitted Date

Jul 18, 2022

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 18, 2022			Aug 9, 2022	2
Dec 14, 2022

Intervention Browse Module

MeSH Terms

ID	Term
D013473	Sunscreening Agents

Ancestor Terms

ID	Term
D011837	Radiation-Protective Agents
D020011	Protective Agents
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided