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
1 other identifier
interventional
15
1 country
1
Brief Summary
The researchers will assess the effects of treatment with tretinoin cream on human skin by using non-invasive optical imaging technologies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Aug 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2015
CompletedFirst Posted
Study publicly available on registry
April 8, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 1, 2022
October 1, 2022
1.3 years
March 23, 2015
October 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Tretinoin cream 0.1%
EXPERIMENTALAssessment of the skin change
Interventions
Eligibility Criteria
You may qualify if:
- Female 45 years of age or older - Skin type scale I to III
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Irvinelead
- Unilever R&Dcollaborator
- Beckman Laser Institute University of California Irvinecollaborator
Study Sites (1)
Beckman Laser Institute Medical Clinic
Irvine, California, 92612, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Mihaela Balu, PhD
Beckman Laser Institute, UCI
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mihaela Balu, Ph.D. Associate Specialist
Study Record Dates
First Submitted
March 23, 2015
First Posted
April 8, 2015
Study Start
August 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
November 1, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share