Flat Wart
Conditions
Keywords
flat wart, isotretinoin, facial warts
Brief summary
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
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.
Interventions
Jelly capsules of isotretinoin
Sponsors
Centro Dermatológico Dr. Ladislao de la Pascua
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
All the interventions will be similar in appearance and all the participants will take the same quantity of capsules.
Intervention model description
Randomized clinical trial of three-arms
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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: 1. Hypercholesterolemia 2. Hypertriglyceridemia 3. Liver disease 4. Renal disease 5. Sjögren syndrome 6. Pregnancy 7. Lactation 8. Depressive disorder 9. Body mass index less than 18 points or higher than 25 points 10. Contraindications for hormonal contraception or intrauterine device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete clearance | 12 weeks | Proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial. |
| Incidence of serious adverse events | 12 weeks | Proportion of participants that developed a serious side effect in the three arms during the clinical trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life index | 12 weeks | 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. |
| Adherence to intervention | 12 weeks | Percentage of taken-doses of oral isotretinoin during the 12 weeks of the study. |
Countries
Mexico
Contacts
Primary ContactMaría Guadalupe Olguín-García, M.D., MSc.
Backup ContactMartha Alejandra Morales-Sánchez, M.D., MSc.
Outcome results
None listed