Acne CysticPhase 4NCT07228481
Study of Two Dosages of Roaccutane in Cystic Acne
A Phase 4 study testing isotretinoin (Roaccutane) in people with Acne Cystic, run by Premier Specialists, Australia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acne Cystic
- What is being tested?
- isotretinoin (Roaccutane)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- 26 Jun 2001to 10 May 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Randomised Controlled Trial of Two Different Cumulative Dosages of Roaccutane for 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.
- Conditions
- Acne Cystic
- Being tested
- isotretinoin (Roaccutane)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
isotretinoin (Roaccutane)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Roaccutane 120 mg/kg Group | Experimental | 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. Receives: Drug: isotretinoin (Roaccutane) |
| Roaccutane 150 mg/kg Group | Experimental | 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. Receives: Drug: isotretinoin (Roaccutane) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Acne Lesion Count During Isotretinoin Treatment
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.
Measured: 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 During Isotretinoin Treatment
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.
Measured: 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)
Secondary outcomes (3)
Rate of Acne Relapse at 3 Months After End of 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.
Measured: 3 months after completion of isotretinoin treatment
Rate of Acne Relapse at 12 Months After End of 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.
Measured: 12 months after completion of isotretinoin treatment
Change in Acne Scarring Over Time
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start26 Jun 2001
- Primary completion1 Mar 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne CysticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two treatment groups receiving different cumulative doses of Roaccutane (120 mg/kg or 150 mg/kg). Outcome assessments were performed by blinded evaluators.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Premier Specialists, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Principal investigator, Dedee Murrell, Premier Specialists, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228481
- Sponsor's protocol ID
- ROC-ACNE
- Status last verified
- Dec 2025
- First submitted
- 7 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The study was conducted before data sharing requirements were established, and participants did not provide consent for their data to be publicly released. No data-sharing infrastructure or plan was created at the time of the study.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Two Different Cumulative Dosages of Roaccutane for Cystic Acne
- ClinicalTrials.gov ID
- NCT07228481
- Acronym / sponsor ID
- ROC-ACNE
- Conditions
- Acne Cystic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Premier Specialists, AustraliaUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- 26 Jun 2001 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two treatment groups receiving different cumulative doses of Roaccutane (120 mg/kg or 150 mg/kg). Outcome assessments were performed by blinded evaluators.
| Arm | Type | Receives |
|---|---|---|
| Roaccutane 120 mg/kg Group | Experimental | Drug: isotretinoin (Roaccutane)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. |
| Roaccutane 150 mg/kg Group | Experimental | Drug: isotretinoin (Roaccutane)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Roaccutane 120 mg/kg Group |
| 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. | Drug | Roaccutane 150 mg/kg Group |
Primary outcome
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.
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.
3 secondary outcomes
Rate of Acne Relapse at 3 Months After End of Treatment
Time frame: 3 months after completion of isotretinoin treatment
Rate of Acne Relapse at 12 Months After End of Treatment
Time frame: 12 months after completion of isotretinoin treatment
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The study was conducted before data sharing requirements were established, and participants did not provide consent for their data to be publicly released. No data-sharing infrastructure or plan was created at the time of the study.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing isotretinoin (Roaccutane) in people with Acne Cystic, run by Premier Specialists, Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.