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Completed

NCT Number: NCT07228481

Study of Two Dosages of Roaccutane in Cystic Acne

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.

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Key information

Conditions

Acne Cystic

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female subjects, of any age and any race
  • Clinical diagnosis of nodulo-cystic acne as well as patients who have been unresponsive to standard acne vulgaris treatments

Exclusion criteria

  • Pregnant or lactating female patients
  • Female patients with polycystic ovarian syndrome, insulin resistance syndrome, previous use of Roaccutane, patients with congenital adrenal hyperplasia, patients with any internal malignancy (excluding skin cancer)
  • Females of reproductive potential who refuse to take the oral contraceptive pill to take Roaccutane; patients who in the investigator's opinion would be unlikely to be compliant

Treatment and study plan

isotretinoin (Roaccutane)

Drug

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.

Primary outcomes

  1. Change in Total Acne Lesion Count During Isotretinoin Treatment

    Time frame: Baseline, Week 16, and end of treatment (defined as the visit at which the assigned cumulative dose of 120 mg/kg or 150 mg/kg was reached)

    Change in the total number of acne lesions (whiteheads, blackheads, papules, pustules, nodules, and deep pustules) measured on the face, chest, and back from baseline to week 16, and to the cumulative doses of 120 mg/kg and 150 mg/kg isotretinoin (Roaccutane).

    Results will be reported as the mean number of lesions at each time point. Lower counts indicate better clinical response.

  2. Change in Acne Severity Grade During Isotretinoin Treatment

    Time frame: Baseline, Week 16, and end of treatment (defined as the visit at which the assigned cumulative dose of 120 mg/kg or 150 mg/kg was reached)

    Change in acne severity grade, ranging from 1 (least severe) to 8 (most severe), according to the classification described in Dermatology 1999;198:278-283 (Karger).

    Assessments are performed at baseline, week 16, and at cumulative isotretinoin doses of 120 mg/kg and 150 mg/kg.

    Results will be reported as mean acne grade (1-8 scale); lower scores indicate better outcome.

Secondary outcomes

  1. Rate of Acne Relapse at 3 Months After End of Treatment

    Time frame: 3 months after completion of isotretinoin treatment

    Proportion of participants experiencing recurrence of inflammatory acne lesions requiring further systemic or topical therapy within 3 months following completion of isotretinoin treatment (at either 120 mg/kg or 150 mg/kg cumulative dose).

    Results will be expressed as percentage of participants with relapse.

  2. Rate of Acne Relapse at 12 Months After End of Treatment

    Time frame: 12 months after completion of isotretinoin treatment

    Proportion of participants experiencing recurrence of inflammatory acne lesions requiring further systemic or topical therapy within 12 months following completion of isotretinoin treatment (at either 120 mg/kg or 150 mg/kg cumulative dose).

    Results will be expressed as percentage of participants with relapse.

  3. Change in Acne Scarring Over Time

    Time frame: Baseline, end of treatment (defined as the visit at which the assigned cumulative dose of 120 mg/kg or 150 mg/kg was reached) and 12 months after completion of treatment

    Change in the number of atrophic and hypertrophic scars on the face, chest, and back from baseline to end of treatment and to 12-month follow-up. Results will be reported as mean scar counts at each time point.

Sponsors and collaborators

Lead sponsor

Premier Specialists, Australia

Other

Collaborators

  • Roche Products Limited

Registry information

Official study title

Randomised Controlled Trial of Two Different Cumulative Dosages of Roaccutane for Cystic Acne

Important dates

Study start
2001
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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