Efficacy and Safety of Oral Isotretinoin for the Treatment of Facial Recalcitrant Flat Warts
1 other identifier
interventional
162
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2020
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2020
CompletedFirst Posted
Study publicly available on registry
March 2, 2020
CompletedStudy Start
First participant enrolled
March 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 3, 2020
February 1, 2020
3 years
February 27, 2020
February 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Quality of life index
12 weeks
Adherence to intervention
12 weeks
Study Arms (3)
Isotretinoin 10 mg/day
EXPERIMENTALOne capsule of isotretinoin 10 mg plus one capsule of placebo, per day during 12 weeks.
Isotretinoin 20 mg/day
EXPERIMENTALOne capsule of isotretinoin 20 mg plus one capsule of placebo, per day during 12 weeks.
Isotretinoin 30 mg/day
ACTIVE COMPARATOROne capsule of isotretinoin 10 mg plus one capsule of isotretinoin 20 mg, per day during 12 weeks.
Interventions
Jelly capsules of isotretinoin
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Have the following conditions:
- Hypercholesterolemia
- Hypertriglyceridemia
- Liver disease
- Renal disease
- Sjögren syndrome
- Pregnancy
- Lactation
- Depressive disorder
- Body mass index less than 18 points or higher than 25 points
- Contraindications for hormonal contraception or intrauterine device.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro Dermatológico "Dr. Ladislao de la Pascua"
Mexico City, 06780, Mexico
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
María Guadalupe Olguín-García, M.D.,MSc.
Centro Dermatológico Dr. Ladislao de la Pascua
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- All the interventions will be similar in appearance and all the participants will take the same quantity of capsules.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2020
First Posted
March 2, 2020
Study Start
March 15, 2020
Primary Completion
February 28, 2023
Study Completion
December 31, 2023
Last Updated
March 3, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share