Study of Two Dosages of Roaccutane in Cystic Acne

Premier Specialists, Australia

Status and phase: Completed; Phase 4

Conditions: Acne Cystic

Treatments: Drug: isotretinoin (Roaccutane)

Study type: Interventional

Funder types: Other

Identifiers

NCT07228481

ROC-ACNE

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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91 participants in 2 patient groups

Roaccutane 120 mg/kg Group

Experimental group

Description:

Participants in this arm received a cumulative dose of approximately 120 mg/kg of Roaccutane (isotretinoin) administered over the treatment period. Dosing was adjusted according to body weight and clinical response, following standard isotretinoin treatment protocols. The outcomes in this group were compared with those in the 150 mg/kg group to assess differences in efficacy, relapse rate, and adverse effects.

Treatment:

Drug: isotretinoin (Roaccutane)

Drug: isotretinoin (Roaccutane)

Roaccutane 150 mg/kg Group

Experimental group

Description:

Participants in this arm received a cumulative dose of approximately 150 mg/kg of Roaccutane (isotretinoin) administered over the treatment period. Dosing was adjusted according to body weight and standard clinical guidelines for isotretinoin therapy. The outcomes for this group were compared with those of the 120 mg/kg group to evaluate differences in efficacy, relapse rates, and adverse effects.

Treatment:

Drug: isotretinoin (Roaccutane)

Drug: isotretinoin (Roaccutane)