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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-15

Study Completion Date

2023-12-31

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.

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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.

Conditions

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Flat Wart

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial of three-arms

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

All the interventions will be similar in appearance and all the participants will take the same quantity of capsules.

Study Groups

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Isotretinoin 10 mg/day

One capsule of isotretinoin 10 mg plus one capsule of placebo, per day during 12 weeks.

Group Type EXPERIMENTAL

Isotretinoin capsules

Intervention Type DRUG

Jelly capsules of isotretinoin

Isotretinoin 20 mg/day

One capsule of isotretinoin 20 mg plus one capsule of placebo, per day during 12 weeks.

Group Type EXPERIMENTAL

Isotretinoin capsules

Intervention Type DRUG

Jelly capsules of isotretinoin

Isotretinoin 30 mg/day

One capsule of isotretinoin 10 mg plus one capsule of isotretinoin 20 mg, per day during 12 weeks.

Group Type ACTIVE_COMPARATOR

Isotretinoin capsules

Intervention Type DRUG

Jelly capsules of isotretinoin

Interventions

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Isotretinoin capsules

Jelly capsules of isotretinoin

Intervention Type DRUG

Other Intervention Names

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Oral retinoid

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:

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No