Trial · NCT07228481
Study of Two Dosages of Roaccutane in Cystic Acne
NCT07228481, Phase 4, Completed, Premier Specialists, Australia
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Two Dosages of Roaccutane in Cystic Acne. Trials, record NCT07228481. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07228481
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Two Dosages of Roaccutane in Cystic Acne
- NCT number
- NCT07228481
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 91 participants, actual
- Lead sponsor
- Premier Specialists, Australia
- Conditions
- Acne Cystic
- Interventions
- isotretinoin (Roaccutane), isotretinoin (Roaccutane)
- First posted
- 2025-11-14
- Last updated
- 2025-12-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Total Acne Lesion Count During Isotretinoin Treatment | 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. |
| Primary | Change in Acne Severity Grade During Isotretinoin Treatment | 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 | Rate of Acne Relapse at 3 Months After End of Treatment | 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. |
| Secondary | Rate of Acne Relapse at 12 Months After End of Treatment | 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. |
| Secondary | Change in Acne Scarring Over Time | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07228481
GET https://conductscience.org/api/trials/v1/NCT07228481/registered