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| Name | Class |
|---|---|
| Roche Products Limited | UNKNOWN |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months after completion of isotretinoin treatment |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 23, 2005 | Oct 21, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: For Minors | Oct 17, 2000 | Oct 21, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: For Adults | Oct 17, 2000 | Oct 21, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D015474 | Isotretinoin |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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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.
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|
| 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. |
|
| 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. | 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. | 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 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |