Efficacy and Safety of Oral Isotretinoin for the Treatment of Facial Recalcitrant Flat Warts

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety of Oral Isotretinoin 10 mg, 20 mg and 30 mg for the Treatment of Facial Recalcitrant Flat Warts at Centro Dermatológico Dr. Ladislao de la Pascua: Randomized Double-blinded Clinical Trial of Three Arms

Conditions
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Flat Wart

Intervention / Treatment
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* Drug: Isotretinoin capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical and histological diagnosis of facial flats warts More than 2 years with facial flat warts Without response to 2 or more topical interventions (tretinoin, imiquimod, cryosurgery and 5-fluorouracil) or oral interventions (cimetidine or zinc sulfate) Exclusion Criteria: Have the following conditions: Hypercholesterolemia Hypertriglyceridemia Liver disease Renal disease Sjögren syndrome Pregnancy Lactation Depressive disorder Body mass index less than 18 points or higher than 25 points Contraindications for hormonal contraception or intrauterine device.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial of three-arms
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isotretinoin 10 mg/day<br>One capsule of isotretinoin 10 mg plus one capsule of placebo, per day during 12 weeks. | Drug: Isotretinoin capsules<br>* Jelly capsules of isotretinoin<br>* Other names: Oral retinoid;|
| Experimental: Isotretinoin 20 mg/day<br>One capsule of isotretinoin 20 mg plus one capsule of placebo, per day during 12 weeks. | Drug: Isotretinoin capsules<br>* Jelly capsules of isotretinoin<br>* Other names: Oral retinoid;|
| Active Comparator: Isotretinoin 30 mg/day<br>One capsule of isotretinoin 10 mg plus one capsule of isotretinoin 20 mg, per day during 12 weeks. | Drug: Isotretinoin capsules<br>* Jelly capsules of isotretinoin<br>* Other names: Oral retinoid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| Incidence of serious adverse events | Proportion of participants that developed a serious side effect in the three arms during the clinical trial. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| Adherence to intervention | Percentage of taken-doses of oral isotretinoin during the 12 weeks of the study. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flat wart, isotretinoin, facial warts