Acne Remission Maintenance by Weekend Systemic Isotretinoin

NCT06451237 | Completed Phase 3 DMC

• 1 other identifier: 0107396
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• subjective patient satisfaction by maintenance regimen

  one year

• Subjective convenience of maintenance regimen to patient

  one year

Study Arms (3)

Adapalene group

ACTIVE COMPARATOR

Patients received full Isotretinoin course for treatment, and maintained on every other day adapalene gel.

Drug: Isotretinoin capsules

Full Iso group

ACTIVE COMPARATOR

Patients received full isotretinoin course for treatment, and maintained on weekend isotretinoin.

Drug: Isotretinoin capsules

Clearance Iso

ACTIVE COMPARATOR

Patients treated by systemic isotretinoin till full clearance and for a month thereafter, and maintained on weekend isotretinoin.

Drug: Isotretinoin capsules

Interventions

Isotretinoin capsules DRUG

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

Also known as: Adapalene gel

Adapalene group; Clearance Iso; Full Iso group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, 2500, Egypt

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Isotretinoin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Carmen Farid, MD

  Professor of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The assessor responsible for the follow up (assessing primary and secondary measures) during the treatment and maintenance phases was blinded to the line of treatment used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology, Venereology and Andrology

Model Details: Interventional study on 3 parallel groups, with random assignment and longitudinal follow up, conducted in two phases (treatment and maintenance).

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: June 11, 2024
• Study Start: January 20, 2018
• Primary Completion: December 20, 2022
• Study Completion: September 20, 2023
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)