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

NCT ID: NCT02410980

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-12-31

Brief Summary

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

Detailed Description

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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.

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

Conditions

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Collagen Fibril Alteration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tretinoin cream 0.1%

Assessment of the skin change

Group Type EXPERIMENTAL

Tretinoin cream 0.1%

Intervention Type DRUG

Assessment of the skin change

Interventions

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Tretinoin cream 0.1%

Assessment of the skin change

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Unilever R&D

INDUSTRY

Sponsor Role collaborator

Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Beckman Laser Institute and Medical Center

Mihaela Balu, Ph.D. Associate Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mihaela Balu, PhD

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute, UCI

Locations

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Beckman Laser Institute Medical Clinic

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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20141508

Identifier Type: -

Identifier Source: org_study_id

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