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

Flat Wart Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04290572
• Other study ID #: 176/2019
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 15, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2020
• Source: Centro Dermatológico Dr. Ladislao de la Pascua
• Contact: María Guadalupe Olguín-García, M.D., MSc.
• Phone: 55387033
• Email: olguingog[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: December 31, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Flat Wart
• Warts

Intervention

Drug:
• Isotretinoin capsules
Jelly capsules of isotretinoin

Locations

Country	Name	City	State
Mexico	Centro Dermatológico "Dr. Ladislao de la Pascua"	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Centro Dermatológico Dr. Ladislao de la Pascua

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Adherence to intervention	Percentage of taken-doses of oral isotretinoin during the 12 weeks of the study.	12 weeks