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This is a randomized, comparative, single evaluator-blinded trial to evaluate clinical, histological and immunohistochemical effects of oral isotretinoin plus moisturizer sunscreen as compared to the use of 0,05% tretinoin cream plus moisturizer sunscreen for the treatment of photodamage on face and forearms. Main oral isotretinoin safety parameters will also be analyzed, as well as adverse events related to topical products.
A 24-week study, with 7 or 9 monthly visits, comprising healthy adult volunteers, aged 50 to 75 years will be carried out. The patients should present advanced to severe photodamage on face and forearms. Written informed consent will be obtained from each subject prior to enrollment.
Eligible patients will be randomly divided in two groups:
A- 10 patients will be treated with oral isotretinoin, 20.0 mg/day, every other day, 15 capsules per month, for 24 weeks, associated with the use of moisturizer broad spectrum sunscreen twice a day.
B- 10 patients (controls) will be treated with 0,05% tretinoin cream applied on face and forearms at night and the same moisturizer broad-spectrum sunscreen twice a day.
After randomization, laboratory tests will be requested for patients from group A and will be repeated on weeks 4 and 24.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral isotretinoin | Active Comparator | Twelve subjects will be treated with oral isotretinoin 20.0 mg, once a day, every other day, for 24 weeks. |
|
| tretinoin | Active Comparator | Twelve patients will be treated with 0,05% tretinoin cream applied on face and forearms at night and moisturizer broad-spectrum sunscreen twice a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral isotretinoin | Drug | one 20.0 mg capsule, once a day, every other day, during 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical, histological and immunohistochemical features before and after treatments | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edileia Bagatin, MD, PhD | Federal University of Sao Paulo, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Sao Paulo | São Paulo | São Paulo | 04022000 | Brazil |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 16, 2011 | |
| Reset | Jun 14, 2011 | |
| Release | Jun 22, 2011 | |
| Reset | Jul 20, 2011 | |
| Release | Aug 2, 2011 | |
| Reset | Aug 31, 2011 | |
| Release | Sep 9, 2011 | |
| Reset | Oct 12, 2011 | |
| Release | Jan 16, 2012 | |
| Reset | Feb 17, 2012 | |
| Release | Feb 25, 2012 | |
| Reset | Mar 30, 2012 | |
| Release | Aug 7, 2017 | |
| Reset | Feb 16, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 16, 2011 | Jun 14, 2011 | |||
| Jun 22, 2011 |
| ID | Term |
|---|---|
| D015474 | Isotretinoin |
| D012176 | Retinoids |
| D014212 | Tretinoin |
| ID | Term |
|---|---|
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
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| Tretinoin | Drug | 0.05% tretinoin cream applied on face and forearms, once a day, in the night, during 24 weeks |
|
|
| Jul 20, 2011 |
| Aug 2, 2011 | Aug 31, 2011 |
| Sep 9, 2011 | Oct 12, 2011 |
| Jan 16, 2012 | Feb 17, 2012 |
| Feb 25, 2012 | Mar 30, 2012 |
| Aug 7, 2017 | Feb 16, 2018 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D014801 | Vitamin A |
| D004224 | Diterpenes |