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Study of Two Dosages of Roaccutane in Cystic Acne

NCT07228481 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2025-12-23

No results posted yet for this study

Summary

This randomized, single-blind, controlled trial was initiated in 2001 to compare two cumulative isotretinoin doses (120 mg/kg vs 150 mg/kg) in patients with moderate-to-severe nodulo-cystic acne. Participants were assigned to receive a cumulative dose of either 120 mg/kg or 150 mg/kg, administered according to body weight and clinical response.

The primary objectives were to evaluate changes in total acne lesion counts and global acne severity grade from baseline through mid-treatment and end of treatment. Secondary objectives included assessing acne recurrence within 12 months after treatment completion and evaluating changes in acne scarring on the face, chest, and back over follow-up.

A small post-hoc extension cohort included patients who had not achieved satisfactory improvement after reaching their assigned cumulative dose and continued isotretinoin beyond standard targets. These patients were analysed descriptively.

Conditions

  • Acne Cystic

Interventions

DRUG

isotretinoin (Roaccutane)

Oral administration of isotretinoin (Roaccutane) in capsule form, with cumulative dosage of 120 mg/kg. Dosing was adjusted according to body weight and administered over a period consistent with standard clinical protocols. The intervention was conducted as part of a randomized, single-blind controlled trial with blinded outcome assessment evaluating efficacy, relapse rates, and adverse events in patients with cystic acne.

DRUG

isotretinoin (Roaccutane)

Oral administration of isotretinoin (Roaccutane) in capsule form, with cumulative dosage of 150 mg/kg. Dosing was adjusted according to body weight and administered over a period consistent with standard clinical protocols. The intervention was conducted as part of a randomized, single-blind controlled trial with blinded outcome assessment evaluating efficacy, relapse rates, and adverse events in patients with cystic acne.

Sponsors & Collaborators

  • Roche Products Limited

    collaborator UNKNOWN

  • Premier Specialists, Australia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-06-26
Primary Completion
2025-03-01
Completion
2025-05-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07228481 on ClinicalTrials.gov