Oral Isotretinoin Versus Topical Tretinoin for Actinic Keratosis (ARISOAK)
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ClinicalTrials.gov Identifier: NCT02278861 |
Recruitment Status :
Completed
First Posted : October 30, 2014
Last Update Posted : October 30, 2014
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Condition or disease | Intervention/treatment | Phase |
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Actinic Keratosis | Drug: Oral isotretinoin Drug: Tretinoin 0,05% cream Drug: Sunscreen FPS 60 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Low Dose Oral Isotretinoin Versus Topical Tretinoin for Prevention of Actinic Keratosis in Immunocompetent Patients: a Randomized, Comparative Trial |
Study Start Date : | November 2011 |
Actual Primary Completion Date : | April 2014 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
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Active Comparator: Oral isotretinoin 10mg/day
Oral isotretinoin 10mg/day for 6 months The dose could be reduced if there were any significant laboratory alterations or clinical adverse events, along with sunscreen FPS 60 every 3 hours during the day.
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Drug: Oral isotretinoin
Oral isotretinoin - 10mg/day (one pill) after lunch for six months
Other Name: Acnova Drug: Sunscreen FPS 60 Sunscreen FPS 60 applied on sun exposed areas every 3 hours daily
Other Name: Skin Block 60 Fluide Extreme |
Active Comparator: Tretinoin 0,05% cream
An every other night application of tretinoin 0,05% cream in the face and forearms for 6 months, along with sunscreen FPS 60 every 3 hours during the day. If there were any clinical adverse events the drug could be reduced to twice a week. |
Drug: Tretinoin 0,05% cream
Topical tretinoin 0,05% cream - applied every other night in the face and forearms for six months
Other Name: Vitacid 0,05% cream Drug: Sunscreen FPS 60 Sunscreen FPS 60 applied on sun exposed areas every 3 hours daily
Other Name: Skin Block 60 Fluide Extreme |
- Reduction in the counting of actinic keratosis in the face and forearms [ Time Frame: at the beginning (T0), 120 days (T120) and 300 days (T300) ]The actinic keratosis (AKs) will be counted by the same evaluator twice, in different moments at the same day, at the beginning of the study, after 4 months and at the end (10 months)
- Reduction in the thickness of the stratum corneum [ Time Frame: 4 months (T120) and 10 months (T300) of the study ]Skin biopsies will be taken from patients at the time of randomization (T120) and after the treatment with retinoids (T300) and stained with hematoxilin-eosin (HE)
- Increase in the epithelium thickness [ Time Frame: 4 months (T120) and 10 months (T300) of the study ]Skin biopsies will be taken from patients at the time of randomization (T120) and after the treatment with retinoids (T300) and stained with hematoxilin-eosin (HE)
- Reduction in the expression of p53 protein [ Time Frame: 4 months (T120) and 10 months (T300) of the study ]Skin biopsies will be taken from patients at the time of randomization (T120) and after the treatment with retinoids (T300). Retinoids are known to reduce the expression of this marker of carcinogenesis.
- Reduction in the expression of the Bcl-2 protein [ Time Frame: 4 months (T120) and 10 months (T300) of the study ]Skin biopsies will be taken from patients at the time of randomization (T120) and after the treatment with retinoids (T300). Retinoids are known to reduce the expression of this marker of carcinogenesis.
- Increase in the expression of Bax protein [ Time Frame: 4 months (T120) and 10 months (T300) of the study ]Skin biopsies will be taken from patients at the time of randomization (T120) and after the treatment with retinoids (T300). Retinoids are known to increase the expression of this marker of carcinogenesis.
- Reduction in the Dermatology Life Quality Index (DLQI) [ Time Frame: at the beginning, with 4 months (T120) and 10 months (T300) of the study ]The Dermatology Life Quality Index (DLQI) questionnaire is performed for every patient at the time frames specified. With the reduction of actinic keratosis and use of retinoids it is expected for retinoids to reduce points of the questionnaire.
- Clinical adverse events of tretinoin [ Time Frame: 4 months (T120) and 10 months (T300) of the study ]The clinical adverse events with tretinoin 0,05% cream are: erythema, burning sensation, desquamation, irritation The clinical adverse events with oral isotretinoin are: cheilitis, xerophthalmia, xerostomia, dry skin, epistaxis, and other mucocutaneous side effects
- Laboratory alterations in patients treated with low dose oral isotretinoin (10mg/day) [ Time Frame: 4 months (T120), 6 months (T180) and 10 months (T300). If there were alterations, the laboratory tests were done monthly ]
At day 120 (4 months) the patients of isotretinoin group (ISO) were submitted to laboratory tests: complete blood count, alanine and aspartate aminotransferase, fasting plasma glucose test and lipid profile tests.
At day 180 (6 months) the laboratory tests were repeated, except fasting plasma glucose test At day 300 (10 months) the laboratory tests were asked and repeated after 1 month, except fasting plasma glucose test

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Ages Eligible for Study: | 50 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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;
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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 Criteria:
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 ;
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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;
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278861
Brazil | |
Dermatology Outpatient Clinic - Hospital das Clínicas - Federal University of Goias (UFG) | |
Goiânia, Goiás, Brazil, 74605-020 |
Study Chair: | Edileia Bagatin, MD, PhD | Federal University of São Paulo UNIFESP | |
Study Chair: | Hélio A Miot, MD, PhD | University of Paulista State - Julio de Mesquita Filho, UNESP |
Responsible Party: | Mayra Ianhez, Assistant Professor, MD, MsC, Universidade Federal de Goias |
ClinicalTrials.gov Identifier: | NCT02278861 |
Other Study ID Numbers: |
UFG 133/11 |
First Posted: | October 30, 2014 Key Record Dates |
Last Update Posted: | October 30, 2014 |
Last Verified: | October 2014 |
actinic keratosis tretinoin isotretinoin |
cryotherapy sun protection factor clinical clearance |
Keratosis, Actinic Keratosis Skin Diseases Precancerous Conditions Neoplasms Tretinoin Isotretinoin |
Sunscreening Agents Dermatologic Agents Antineoplastic Agents Keratolytic Agents Radiation-Protective Agents Protective Agents Physiological Effects of Drugs |