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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Flat Wart
• Intervention / Treatment: Drug: Isotretinoin capsules

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 Type: Interventional
• Enrollment (Anticipated): 162
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: María Guadalupe Olguín-García, M.D., MSc.; Phone Number: 312 55387033; Email: olguingog@gmail.com
• Study Contact Backup: Name: Martha Alejandra Morales-Sánchez, M.D., MSc.; Phone Number: 312 55387033; Email: mmoraless@sersalud.cdmx.gob.mx

Study Locations

• Mexico
  • Mexico City, Mexico, 06780
    • Centro Dermatológico "Dr. Ladislao de la Pascua"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centro Dermatológico Dr. Ladislao de la Pascua
• Investigators: Principal Investigator: María Guadalupe Olguín-García, M.D.,MSc., Centro Dermatológico Dr. Ladislao de la Pascua

Study record dates

Study Major Dates

• Study Start (Anticipated): March 15, 2020
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: February 28, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: isotretinoin; flat wart; facial warts
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts; Dermatologic Agents; Isotretinoin
• Other Study ID Numbers: 176/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No