Assessing the Effects of Tretinoin Cream on Human Skin Wi... | NCT02410980

Studies
Assessing the Effects of Tretinoin Cream on Human Skin With Optical Imaging Technologies

NCT02410980

Sponsor

University of California, Irvine

Status

Completed

Last Update Posted

Nov 1, 2022Actual

Enrollment

15Actual

Phase

Early Phase 1

Conditions

Collagen Fibril Alteration

Interventions

Tretinoin cream 0.1%

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

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Mar 23, 2015

First Submission Date that Met QC Criteria

Apr 7, 2015

First Posted Date

Apr 8, 2015Estimated

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

Oct 28, 2022

Last Update Posted Date

Nov 1, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Beckman Laser Institute and Medical Center, Mihaela Balu, Ph.D. Associate Specialist, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Name	Class
Unilever R&D	INDUSTRY
Beckman Laser Institute University of California Irvine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The researchers will assess the effects of treatment with tretinoin cream on human skin by using non-invasive optical imaging technologies.

Detailed Description

The researchers will evaluate changes in the dermis and skin properties as the effect of treatment with Tretinoin cream (0.1%) by using the following optical imaging techniques.

Multiphoton microscopy using a clinical tomograph (MPTflex, Jenlab, Germany)
Multispectral Imaging using a device developed at Beckman Laser Institute, UC Irvine

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tretinoin cream 0.1%	Experimental	Assessment of the skin change	Drug: Tretinoin cream 0.1%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tretinoin cream 0.1%	Drug	Assessment of the skin change	Tretinoin cream 0.1%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skin Collagen/Elastin ratio over time - Change from baseline in sun exposed, and non sun exposed skin areas.	The effects of tretinoin cream on human skin will be measured.	up to 2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female 45 years of age or older - Skin type scale I to III

Exclusion Criteria:

Large amount of dark, coarse hair on the arms
History of allergies to alpha hydroxy acids (AHAs), retinoids, soaps, fragrances, sunscreens or Latex
Currently using over-the-counter AHA or retinol within one month or prescription retinoid within three months of the start of the study.
History of skin cancer, including squamous or basal cell carcinoma at the treatment site or history of malignant melanoma.
History of diabetes
Currently pregnant or nursing

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 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
Mihaela Balu, PhD	Beckman Laser Institute, UCI	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beckman Laser Institute Medical Clinic		Irvine	California	92612	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