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

Phase 3

• Conditions: Flat Wart
• Interventions: Drug: Isotretinoin capsules

• Registration Number: NCT04290572
• Lead Sponsor: Centro Dermatológico Dr. Ladislao de la Pascua

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.

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-02-28
• Last Update Submitted: 2020-02-28
• Study First Posted: 2020-03-02
• Last Update Posted: 2020-03-03
• Study Start: 2020-03-15
• Primary Completion: 2023-02-28
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 162

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isotretinoin 10 mg/day	Isotretinoin capsules	One capsule of isotretinoin 10 mg plus one capsule of placebo, per day during 12 weeks.
Isotretinoin 20 mg/day	Isotretinoin capsules	One capsule of isotretinoin 20 mg plus one capsule of placebo, per day during 12 weeks.
Isotretinoin 30 mg/day	Isotretinoin capsules	One capsule of isotretinoin 10 mg plus one capsule of isotretinoin 20 mg, per day during 12 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Centro Dermatológico "Dr. Ladislao de la Pascua"; 🇲🇽 Mexico City, Mexico