Acne Remission Maintenance by Weekend Systemic Isotretinoin

Alexandria University

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Isotretinoin capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT06451237

0107396

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Adapalene group

Active Comparator group

Description:

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

Treatment:

Drug: Isotretinoin capsules

Full Iso group

Active Comparator group

Description:

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

Treatment:

Drug: Isotretinoin capsules

Clearance Iso

Active Comparator group

Description:

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

Treatment:

Drug: Isotretinoin capsules