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

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

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

Study Overview

• Status: Completed
• Conditions: Collagen Fibril Alteration
• Intervention / Treatment: Drug: Tretinoin cream 0.1%

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.

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

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92612
      • Beckman Laser Institute Medical Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tretinoin cream 0.1%; Assessment of the skin change	Drug: Tretinoin cream 0.1%; Assessment of the skin change

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: Beckman Laser Institute University of California Irvine; Unilever R&D
• Investigators: Principal Investigator: Mihaela Balu, PhD, Beckman Laser Institute, UCI

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: April 7, 2015
• First Posted (ESTIMATE): April 8, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Dermatologic Agents; Keratolytic Agents; Tretinoin
• Other Study ID Numbers: 20141508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO