Collagen Fibril AlterationEarly Phase 1NCT02410980
Assessing the Effects of Tretinoin Cream on Human Skin With Optical Imaging Technologies
A Early Phase 1 study testing Tretinoin cream 0.1% in people with Collagen Fibril Alteration, run by University of California, Irvine at 1 site in United States.
Trial summary
The researchers will assess the effects of treatment with tretinoin cream on human skin by using non-invasive optical imaging technologies. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Collagen Fibril Alteration
- What is being tested?
- Tretinoin cream 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female 45 years of age or older - Skin type scale I to III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beckman Laser Institute Medical Clinic
Irvine, California, 92612
About this study
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
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.
- Multiphoton microscopy using a clinical tomograph (MPTflex, Jenlab, Germany)
- Multispectral Imaging using a device developed at Beckman Laser Institute, UC Irvine
- Conditions
- Collagen Fibril Alteration
- Being tested
- Tretinoin cream 0.1%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tretinoin cream 0.1%Drug
Assessment of the skin change
| Study group | Role | What they receive |
|---|---|---|
| Tretinoin cream 0.1% | Experimental | Assessment of the skin change Receives: Drug: Tretinoin cream 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collagen Fibril AlterationStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D, Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Mihaela Balu, PhD, Principal investigator, Beckman Laser Institute, UCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410980
- Sponsor's protocol ID
- 20141508
- Status last verified
- Oct 2022
- First submitted
- 23 Mar 2015
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02410980
- Acronym / sponsor ID
- 20141508
- Conditions
- Collagen Fibril Alteration
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Unilever R&D, Beckman Laser Institute University of California Irvine
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers will assess the effects of treatment with tretinoin cream on human skin by using non-invasive optical imaging technologies.
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.
- Multiphoton microscopy using a clinical tomograph (MPTflex, Jenlab, Germany)
- Multispectral Imaging using a device developed at Beckman Laser Institute, UC Irvine
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tretinoin cream 0.1% | Experimental | Drug: Tretinoin cream 0.1%Assessment of the skin change |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female 45 years of age or older - Skin type scale I to III
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tretinoin cream 0.1%Assessment of the skin change | Drug | Tretinoin cream 0.1% |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihaela Balu, PhD principal investigator
Beckman Laser Institute, UCI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tretinoin cream 0.1% in people with Collagen Fibril Alteration, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Collagen/Elastin ratio over time - Change from baseline in sun exposed, and non sun exposed skin areas. (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.