Status:
COMPLETED
Oral Isotretinoin Versus Topical Tretinoin for Actinic Keratosis
Lead Sponsor:
Universidade Federal de Goias
Collaborating Sponsors:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Theraskin
Conditions:
Actinic Keratosis
Eligibility:
All Genders
50-75 years
Phase:
PHASE2
Brief Summary
Actinic keratosis (AKs) are premalignant disorders that can evolve into skin cancer. To prevent their development, a study is being conducted with oral isotretinoin and topical tretinoin to verify wha...
Detailed Description
This study is a randomized controlled trial with 60 men and women (already in menopause for at least one year), aged 50-75 years. At the beginning, the number of actinic keratosis (AKs) of face and fo...
Eligibility Criteria
Inclusion
- Signature of the Free and Clarified Consent Term before any procedure of the study;
- Men and women, aged 50-75 years, in good health;
- Women in menopause for 1 year or more;
- Phototypes I-IV by Fitzpatrick classification;
- Glogau photodamage classification scale from moderate to severe
- At least 10 and maximum 60 visible and/or palpable actinic keratosis, in the face and forearms, in a standardized distribution;
- Absence of topical treatment in the face and forearms, except sunscreens, with:
- tretinoin in the last 6 months;
- alphahydroxyacids, polyhydroxyacids, betahydroxyacids and ascorbic acid in the last 3 months;
- drugs or procedures that may change the natural evolution of actinic keratosis, such as imiquimod 5% cream, diclofenac 3% in hyauronic acid gel, photodynamic therapy, 5-FU, in the last 6 months;
- Absence of previous treatment in the face and forearms with chemical peels and microdermabrasion, in the last 6 months;
- Absence of previous treatment with oral retinoids in the last 6 months;
- Absence of anti-cancer chemotherapy in the last 3 months;
- Absence of hypersensitivity to parabens (present in the majority of drugs as a preserving agent);
- Absence of infectious or inflammatory diseases in the face and forearms;
- Absence of immunossupression;
- Absence of photodermatosis;
- Agreement in avoiding sun exposure during the research;
- Agreement in not performing any other kind of treatment that could change the natural history of actinic keratosis; and
- Agreement with the study conditions, ability to understand and follow strictly the given orientations, availability to attend the periodical evaluations.
- For the isotretinoin group (ISO):
- Absence of history of isotretinoin hypersensitivity;
- Avoid alcohol intake and;
- Absence of previous and actual history of rheumatologic diseases.
- For the tretinoin group (AR):
- 1\. Absence of history of tretinoin hypersensitivity;
Exclusion
- For all patients:
- Men and women who dón't agree with the terms of the research or without ability to understand and/or follow strictly the conditions of the study, without availability to understand and attend the periodical evaluations or who decline to sign the Free and Clarified Consent Term;
- Patients with less than 10 and more than 60 actinic keratosis in the face and forearms;
- Fertile, pregnant or lactating women;
- Fitzpatrick phototypes V e VI ;
- Topical treatment in the face and forearms, except sunscreens, with:
- tretinoin in the last 6 months;
- alphahydroxyacids, polyhydroxyacids, betahydroxyacids and ascorbic acid in the last 3 months;
- drugs or procedures that may change the natural evolution of actinic keratosis, such as imiquimod 5% cream, diclofenac 3% in hyauronic acid gel, photodynamic therapy, 5-FU, in the last 6 months;
- Previous treatment in the face and forearms with chemical peels and microdermabrasion, in the last 6 months;
- 8\. Previous treatment with oral retinoids in the last 6 months
- For the isotretinoin group (ISO):
- Presence of significative hepatic laboratory alterations (elevated liver enzymes twice ashigh as the upper normal limit;
- Diabetic patients, with fast glucose values superior to 110mg/dl;
- Significant lipid profile alterations (triglycerides \> 300 mg/dl; total cholesterol\> 250 mg/dl);
- Low count of white blood cells (leukocytes \< 3000/mm3);
- History of hypersensitivity to isotretinoin and parabens;
- Alcohol intake;
- Previous or actual history of rheumatologic diseases;
- Anticancer chemotherapy in the last 3 months;
- Previous history of hypervitaminosis A;
- Previous history of bone or muscular diseases;
- Patients who are in use or may use the following drugs (risk of drug interaction):
- tetracyclines and derivatives - in the last 7 days;
- vitamin A - in the last 30 days;
- carbamazepine - in the last 7 days.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02278861
Start Date
November 1 2011
End Date
May 1 2014
Last Update
October 30 2014
Active Locations (1)
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1
Dermatology Outpatient Clinic - Hospital das Clínicas - Federal University of Goias (UFG)
Goiânia, Goiás, Brazil, 74605-020