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Completed

NCT Number: NCT06451237

Acne Remission Maintenance by Weekend Systemic Isotretinoin

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alexandria University

Alexandria, 2500, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isotretinoin capsules

Drug

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

Other names: Adapalene gel

Primary outcomes

  1. Incidence of acne relapse during maintenance phase

    Time frame: one year

    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

  2. Timing of acne relapse after initiating maintenance

    Time frame: one year

    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

  3. Maximum severity of acne relapse during follow up

    Time frame: One year

    Maximum investigator global assessment score reached by the the patient during the follow up year

  4. Incidence of adverse effects

    Time frame: One year

    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, ...

Secondary outcomes

  1. subjective patient satisfaction by maintenance regimen

    Time frame: one year

    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.

  2. Subjective convenience of maintenance regimen to patient

    Time frame: one year

    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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Weekend Systemic Isotretinoin for Maintaining Acne Remission: A Novel Approach

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Jun 11, 2024
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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