Acne Remission Maintenance by Weekend Systemic Isotretinoin

Weekend Systemic Isotretinoin for Maintaining Acne Remission: A Novel Approach

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Isotretinoin capsules

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 2500
    • Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

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
Active Comparator: Adapalene group; Patients received full Isotretinoin course for treatment, and maintained on every other day adapalene gel.	Drug: Isotretinoin capsules; A one year follow up for patients on three maintenance regimens after acne clearance, including weekend isotretinoin and adapalene gel.; Other Names: Adapalene gel
Active Comparator: Full Iso group; Patients received full isotretinoin course for treatment, and maintained on weekend isotretinoin.	Drug: Isotretinoin capsules; A one year follow up for patients on three maintenance regimens after acne clearance, including weekend isotretinoin and adapalene gel.; Other Names: Adapalene gel
Active Comparator: Clearance Iso; Patients treated by systemic isotretinoin till full clearance and for a month thereafter, and maintained on weekend isotretinoin.	Drug: Isotretinoin capsules; A one year follow up for patients on three maintenance regimens after acne clearance, including weekend isotretinoin and adapalene gel.; Other Names: Adapalene gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Carmen Farid, MD, Professor of Dermatology

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2018
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): September 20, 2023

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: June 9, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 9, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Isotretinoin; Adapalene
• Other Study ID Numbers: 0107396

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