Clinical trial NCT04290572: Efficacy and Safety of Oral Isotretinoin for the Treatment of Facial Recalcitrant Flat Warts
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Flat Wart
Keywords: flat wart
isotretinoin
facial warts
Lead sponsor: Centro Dermatológico Dr. Ladislao de la Pascua
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial of three-arms
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete clearance
timeFrame: 12 weeks
measure: Incidence of serious adverse events
timeFrame: 12 weeks
Secondary outcomes:
measure: Quality of life index
timeFrame: 12 weeks
measure: Adherence to intervention
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Centro Dermatológico "Dr. Ladislao de la Pascua"
Study officials:
affiliation: Centro Dermatológico Dr. Ladislao de la Pascua
name: María Guadalupe Olguín-García, M.D.,MSc.
role: PRINCIPAL_INVESTIGATOR
References: