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

This study has been completed.
Sponsor:
Collaborators:
Unilever R&D
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT02410980
First received: March 23, 2015
Last updated: March 3, 2017
Last verified: March 2017
  Purpose
The researchers will assess the effects of treatment with tretinoin cream on human skin by using non-invasive optical imaging technologies.

Condition Intervention Phase
Collagen Fibril Alteration Drug: Tretinoin cream 0.1% Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

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


Enrollment: 15
Study Start Date: August 2015
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tretinoin cream 0.1%
Assessment of the skin change
Drug: Tretinoin cream 0.1%
Assessment of the skin change

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
  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02410980

Locations
United States, California
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
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Mihaela Balu, Ph.D. Associate Specialist, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02410980     History of Changes
Other Study ID Numbers: NIH/LAMMP-Unilever-2014-1508
Study First Received: March 23, 2015
Last Updated: March 3, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Tretinoin
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on June 23, 2017