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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06451237
Other study ID # 0107396
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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