Acne Remission Maintenance by Weekend Systemic Isotretinoin

Acne Vulgaris Clinical Trial

Official title:

Weekend Systemic Isotretinoin for Maintaining Acne Remission: A Novel Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06451237
• Other study ID #: 0107396
• Status: Completed
• Phase: Phase 3
• Start date: January 20, 2018
• Est. completion date: September 20, 2023

Study information

• Verified date: June 2024
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to learn if isotretinoin oral tablets as a weekend regimen are safe and effective to maintain freedom from acne lesions in young adults who have completed a full course of isotretinoin on daily basis and achieved total control of the acne activity.

Description:

Three groups of adult acne patients will be given a full course of isotretinoin with a cumulative dose of 120-150 mg/Kg weight in the 1st two groups, and till lesional clearance in the 3rd group with an additional month of maintenance. Afterwards, the 1st group will use adapalene gel every other day for maintenance, the 2nd and 3rd groups will use weekend oral isotretinoin. Patients will be followed for a year for reappearance of acne lesions, and safety of maintenance regimens. Patients opinion will be also sought.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 20, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (= 18 years) with moderate to severe facial acne, as per the Investigator Global Assessment (IGA) scale

Exclusion Criteria:

• patients on systemic acne medications in the past 3 months or topicals in the last month, pregnant or breastfeeding females, those with evidence of endocrine disturbances or using medications for comorbidities

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Isotretinoin capsules
A one year follow up for patients on three maintenance regimens after acne clearance, including weekend isotretinoin and adapalene gel.

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acne relapse during maintenance phase	percent of patients having one grade worsening of their acne investigator global assessment scale achieved by end of treatment phase as assessed by the physician during follow up	one year
Primary	Timing of acne relapse after initiating maintenance	The time interval between initiating maintenance and the occurrence of one grade worsening of the patient's investigator global assessment scale achieved by the end of treatment phase as assessed by the physician during follow up	one year
Primary	Maximum severity of acne relapse during follow up	Maximum investigator global assessment score reached by the the patient during the follow up year	One year
Primary	Incidence of adverse effects	Percent of patients reporting adverse effects in general, percent of patients reporting each category of side effects, including disturbed lipid profile, raised transaminases, psychological changes, dryness, hair shedding, ...	One year
Secondary	subjective patient satisfaction by maintenance regimen	A patient oriented outcome, in which the patients are asked by the end of maintenance year to report their degree of satisfaction by the efficacy of maintenance regimen to prevent acne relapse on a visual analogue scale of 1-10, in which 1 is lowest satisfaction and 10 is highest satisfaction.	one year
Secondary	Subjective convenience of maintenance regimen to patient	A patient oriented outcome to assess the degree of convenience of the maintenance regimen for the patient as reported on a visual analogue scale of 1-10, where 1 is the lowest convenience, and 10 is the highest convenience.	one year