A Phase 2 interventional study of oral isotretinoin and Tretinoin in Photodamage and Photoaging, sponsored by Federal University of São Paulo. Status unknown at 1 site in Brazil. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-06-08.
Sponsored by Federal University of São Paulo · Phase 2, Interventional, and Treatment
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.
Federal University of São Paulo is the lead sponsor of 438 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Twelve subjects will be treated with oral isotretinoin 20.0 mg, once a day, every other day, for 24 weeks.
Drug: oral isotretinoin
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.
Drug: Tretinoin
one 20.0 mg capsule, once a day, every other day, during 24 weeks
Also known as: oral retinoid
0.05% tretinoin cream applied on face and forearms, once a day, in the night, during 24 weeks
Also known as: topical retinoid, topical tretinoin, topical retinoic acid
Clinical, histological and immunohistochemical features before and after treatments
Time frame: 24 weeks
Quality of life
Time frame: 24 weeks
The record gives a start of May 2009, a primary completion of Dec 2009 and a completion of Aug 2010. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Isotretinoin · Tretinoin
Federal University of São Paulo →