Randomized clinical trial to compare the efficacy of different doses of oral isotretinoin 10 mg/day, 20 mg/day and 30 mg/day during 12 weeks for the treatment of facial recalcitrant flat warts. The primary endpoint will be the proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial.
The investigators will recruit 162 participants with facial recalcitrant flat warts and randomize to the following three arms of intervention: Arm 1: nne capsule of isotretinoin 10 mg plus one capsule of placebo, per day during 12 weeks; Arm 2: one capsule of isotretinoin 20 mg plus one capsule of placebo, per day during 12 weeks; and Arm 3: one capsule of isotretinoin 10 mg plus one capsule of isotretinoin 20 mg, per day during 12 weeks. The primary endpoints will be the proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial; and the incidence of side effects related to oral isotretinoin treatment among the 3 arms of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
162
Jelly capsules of isotretinoin
Centro Dermatológico "Dr. Ladislao de la Pascua"
Mexico City, Mexico
Complete clearance
Proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial.
Time frame: 12 weeks
Incidence of serious adverse events
Proportion of participants that developed a serious side effect in the three arms during the clinical trial.
Time frame: 12 weeks
Quality of life index
Difference in the Dermatology Life Quality Index score at the end of the study, comparing with the basal score. The minimum score is 0 points and the maximum 30 points. A score higher than 10 points means that the patient's life is severely affected by melasma.
Time frame: 12 weeks
Adherence to intervention
Percentage of taken-doses of oral isotretinoin during the 12 weeks of the study.
Time frame: 12 weeks
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