Study Results
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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COMPLETED
PHASE4
91 participants
INTERVENTIONAL
2001-06-26
2025-05-10
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Roaccutane 120 mg/kg Group
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.
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.
Roaccutane 150 mg/kg Group
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of nodulo-cystic acne as well as patients who have been unresponsive to standard acne vulgaris treatments
Exclusion Criteria
* 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
ALL
No
Sponsors
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Roche Products Limited
UNKNOWN
Premier Specialists, Australia
OTHER
Responsible Party
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Dedee Murrell
Professor, Director of Premier Specialists
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form: For Minors
Document Type: Informed Consent Form: For Adults
Other Identifiers
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ROC-ACNE
Identifier Type: -
Identifier Source: org_study_id