Study of Two Dosages of Roaccutane in Cystic Acne (NCT07228481) | Clinical Trial Compass
CompletedPhase 4
Study of Two Dosages of Roaccutane in Cystic Acne
91 participantsStarted 2001-06-26
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared two different doses of Roaccutane (isotretinoin) for cystic acne — since the study is now completed, has the data been published, and would the findings change how you'd decide on my starting dose?
2The trial measured changes in total acne lesion count and severity grade — based on those kinds of outcomes, how would you personally track whether my treatment is working, and at what point would we consider adjusting my dose?
3Since this was a Phase 4 study, meaning isotretinoin was already approved before this trial ran, does that give you more confidence in its safety profile, or are there still side effects I should be especially watchful for at different dose levels?
4Cystic acne can sometimes be managed with other treatments before jumping to isotretinoin — given what this trial was studying about dosing, do you think I should try any alternative approaches first, or is isotretinoin the right path for my situation now?
5If my doctor were to prescribe isotretinoin, how would they decide which dose is right for me specifically, and is that decision influenced by research like this trial comparing two dosage levels?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Total Acne Lesion Count During Isotretinoin Treatment
Timeframe: 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)
2
Change in Acne Severity Grade During Isotretinoin Treatment
Timeframe: 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)