Acne Remission Maintenance by Weekend Systemic Isotretinoin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-20

Study Completion Date

2023-09-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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Adapalene group

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

Group Type ACTIVE_COMPARATOR

Isotretinoin capsules

Intervention Type DRUG

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

Full Iso group

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

Group Type ACTIVE_COMPARATOR

Isotretinoin capsules

Intervention Type DRUG

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

Clearance Iso

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

Group Type ACTIVE_COMPARATOR

Isotretinoin capsules

Intervention Type DRUG

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

Interventions

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Isotretinoin capsules

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

Intervention Type DRUG

Other Intervention Names

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Adapalene gel

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No