Retinol in Aged Skin
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 5, 2009 | ||||||||
| Last Updated Date | March 5, 2009 | ||||||||
| Start Date ICMJE | April 2009 | ||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Retinoid-induced dermatitis [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Retinol in Aged Skin | ||||||||
| Official Title ICMJE | Molecular Analyses of Retinoid-Induced Dermatitis in Aged/Photoaged Human Skin | ||||||||
| Brief 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. 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Skin biopsies will be taken; however, they are not intended to be used for DNA extraction. |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Subjects will be between the ages of 50-60 years of age, with moderate clinical photodamage, and either gender. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 250 | ||||||||
| Estimated Completion Date | June 2012 | ||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 50 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Not Provided | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00857610 | ||||||||
| Other Study ID Numbers ICMJE | Ret-1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Mandy Harting, MD, University of Michigan | ||||||||
| Study Sponsor ICMJE | University of Michigan | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | University of Michigan | ||||||||
| Verification Date | March 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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