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CompletedNCT02410980Updated Nov 1, 2022

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

An Early Phase 1 interventional study of Tretinoin cream 0.1% in Collagen Fibril Alteration, sponsored by University of California, Irvine. Completed at 1 site in United States. Open to female participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-01.

Sponsored by University of California, Irvine · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
45 Years and older
Sex
Female
01

Study summary

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

Read the 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
02

Conditions studied

  • Collagen Fibril Alteration
03

In context

Lead sponsor

University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Female 45 years of age or older - Skin type scale I to III

Exclusion criteria

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
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Tretinoin cream 0.1%

    Assessment of the skin change

    Drug: Tretinoin cream 0.1%

Interventions

  • DrugTretinoin cream 0.1%

    Assessment of the skin change

06

What researchers measure

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.

    Time frame: up to 2 months

07

Study locations

1 site
  • Beckman Laser Institute Medical Clinic
    Irvine, California 92612, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02410980
Lead sponsor
University of California, Irvine
Collaborators
Unilever R&D, Beckman Laser Institute University of California Irvine
Responsible party
Beckman Laser Institute and Medical Center (Mihaela Balu, Ph.D. Associate Specialist, University of California, Irvine) — Principal investigator
First posted
Apr 8, 2015
Start date
Aug 2015
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Nov 1, 2022

Study contacts

Mihaela Balu, PhD
principal investigator · Beckman Laser Institute, UCI

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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