Aged SkinNCT00857610
Retinol-induced Dermatitis in Aged Skin
An observational study of Aged Skin and Photoaged Skin, run by University of Michigan at 1 site in United States.
Trial summary
Topical therapy with retinoids is the only proven medical therapy for aged/photoaged human skin. However, topical therapy with retinoids often result in unwanted cutaneous dermatitis, including erythema and scaling. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aged Skin, Photoaged Skin
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2009to 29 Aug 2014
- Phase
- Observational
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects will be between the ages of 21-60 years of age, with moderate clinical photodamage, and either gender.
Who may be able to join
- Male or female
- Subject is at least 21 years of age
- Good general health
- No disease states, physical conditions or medications that would impair evaluation of the test sites
- Willingness and ability to follow protocol
- Signed written and witnessed informed consent form
- No use of oral retnoids in the past year
- No use of topical steroids to the treatment area in the past 2 weeks
Who cannot join
- Has received an experimental drug or used and experimental device in the 14 days prior to admission to the study
- History of keloids
- History of hypersensitivity to lidocaine or epinephrine
- Pregnant or nursing women
- Disease states or physical condition that would impair evaluation of the test sites or compliance with the protocol
- History of chemical peels or laser treatments to the sites evaluated
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
About this study
Official title: Molecular Analyses of Retinoid-induced Dermatitis in Aged/Photoaged Human Skin
Topical therapy with retinoids is the only proven medical therapy for aged/photoaged human skin. However, topical therapy with retinoids often result in unwanted cutaneous dermatitis, including erythema and scaling. The reseachers intend to investigate the dose, frequency of use, and time dependence of topical retinol-induced dermatitis. The researchers intend to evaluate retinoid-induced dermatitis biochemically, including retinol regulation of retinoid responsive genes that control retinoid metabolism and serve as markers for retinoid bioactivity. The researchers will also investigate the role of EGF receptor pathway in retinoid-induced dermatitis.
- Conditions
- Aged Skin, Photoaged Skin
- Keywords
- Aged skin, Photoaged skin, Retinol, Topical retinoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Subjects using 0.1% retinol one day per week | |
| 2 | Subjects using 0.1% retinol three days per week | |
| 3 | Subjects using 0.1% retinol seven days per week | |
| 4 | Subjects using 0.5% retinol one day per week | |
| 5 | Subjects using 0.5% retinol three days per week | |
| 6 | Subjects using 0.5% retinol seven times per week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinoid-induced dermatitis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study start20 Jul 2009
- Primary completion29 Aug 2014
- Study completion29 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aged SkinStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dana L. Sachs, MD, University of Michigan
- Investigators
- Dana Sachs, MD, Principal investigator, University of Michigan Professor of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857610
- Sponsor's protocol ID
- HUM00026851/ Derm 604
- Status last verified
- Mar 2020
- First submitted
- 5 Mar 2009
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Analyses of Retinoid-induced Dermatitis in Aged/Photoaged Human Skin
- ClinicalTrials.gov ID
- NCT00857610
- Acronym / sponsor ID
- HUM00026851/ Derm 604
- Conditions
- Aged Skin, Photoaged Skin
- Keywords
- Aged skin, Photoaged skin, Retinol, Topical retinoids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 20 Jul 2009 (actual)
- Primary completion
- 29 Aug 2014 (actual)
- Study completion
- 29 Aug 2014 (actual)
- First posted
- 6 Mar 2009 (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.
Topical therapy with retinoids is the only proven medical therapy for aged/photoaged human skin. However, topical therapy with retinoids often result in unwanted cutaneous dermatitis, including erythema and scaling. The reseachers intend to investigate the dose, frequency of use, and time dependence of topical retinol-induced dermatitis. The researchers intend to evaluate retinoid-induced dermatitis biochemically, including retinol regulation of retinoid responsive genes that control retinoid metabolism and serve as markers for retinoid bioactivity. The researchers will also investigate the role of EGF receptor pathway in retinoid-induced dermatitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Subjects using 0.1% retinol one day per week |
| 2 | – | –Subjects using 0.1% retinol three days per week |
| 3 | – | –Subjects using 0.1% retinol seven days per week |
| 4 | – | –Subjects using 0.5% retinol one day per week |
| 5 | – | –Subjects using 0.5% retinol three days per week |
| 6 | – | –Subjects using 0.5% retinol seven times per week |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects will be between the ages of 21-60 years of age, with moderate clinical photodamage, and either gender.
Key inclusion criteria (8 listed)
- Male or female
- Subject is at least 21 years of age
- Good general health
- No disease states, physical conditions or medications that would impair evaluation of the test sites
- Willingness and ability to follow protocol
Key exclusion criteria (6 listed)
- Has received an experimental drug or used and experimental device in the 14 days prior to admission to the study
- History of keloids
- History of hypersensitivity to lidocaine or epinephrine
- Pregnant or nursing women
- Disease states or physical condition that would impair evaluation of the test sites or compliance with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retinoid-induced dermatitis
Time frame: 6 months
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 13 Mar 2020.
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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.
Dana Sachs, MD principal investigator
University of Michigan Professor of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aged Skin and Photoaged Skin, run by University of Michigan 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 8 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 13 Mar 2020. 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.
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?
Retinoid-induced dermatitis (time frame: 6 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 13 Mar 2020; AzTrials last refreshed its copy on 3 Nov 2026.