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

Sponsor

University of California, Irvine (Other)

Overall Status

Completed

CT.gov ID

NCT02410980

Collaborator

Unilever R&D (Industry), Beckman Laser Institute University of California Irvine (Other)

Enrollment

Location

Arm

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Collagen Fibril Alteration	Drug: Tretinoin cream 0.1%	Early Phase 1

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

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

In-vivo Non-invasive Skin Imaging Pilot Study to Assess the Effects of Tretinoin Cream Using Multi-photon Microscopy and Multi-spectral Imaging

Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tretinoin cream 0.1% Assessment of the skin change	Drug: Tretinoin cream 0.1% Assessment of the skin change

Arm

Intervention/Treatment

Experimental: Tretinoin cream 0.1%

Assessment of the skin change

Drug: Tretinoin cream 0.1%

Assessment of the skin change

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beckman Laser Institute Medical Clinic	Irvine	California	United States	92612

Sponsors and Collaborators

University of California, Irvine
Unilever R&D
Beckman Laser Institute University of California Irvine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT02410980

Other Study ID Numbers:

NIH/LAMMP-Unilever-2014-1508

First Posted:

Apr 8, 2015

Last Update Posted:

Mar 7, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Tretinoin

Study Results

No Results Posted as of Mar 7, 2017