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In this multicenter study, patients with dark skin and acne vulgaris will be included. The patients will receive treatment with MAL PDT and placebo PDT.
The treatment period started within 2 weeks of the study screen. Patients received two treatments (MAL PDT and vehicle PDT) to each of the treatment areas, 2 weeks apart, and were followed-up 4 weeks after last treatment. The total duration of the study was 6-8 weeks.
Methyl aminolevulinate 80 mg/g cream (MAL cream 8%)and vehicle was applied for 1.5 hours before illumination (Aktilite® CL128), total light dose 37 J/cm2
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | PDT using MAL crem |
|
| 2 | Placebo Comparator | PDT using Placebo cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methyl aminolevulinate (MAL) PDT | Drug | Cream application followed by illumination with red light |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment | 4 weeks after last treatment, 6 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Erythema Score (Mild and Moderate)Immediately After First PDT | Patients with mild or moderate erythema after first treatment at baseline. | Immediately after treatment at baseline |
| Change in Inflammatory Lesion Counts From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashish C Bhatia, MD | Dermatology Institute of DuPage Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DuPage Medical Group | Naperville | Illinois | 60563 | United States | ||
| Academic Dermatology Associates |
Two areas on the back per patient was treated, one area with Visonac and one with vehicle
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| ID | Title | Description |
|---|---|---|
| FG000 | Visonac Cream With PDT and Vehicle and PDT | Two areas on the back per patient was treated, one area with Visonac and one with vehicle. Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Visonac and Vehicle Cream With PDT | Two areas on the back per patient was treated, one area with Visonac (Methyl aminolevulinate) and one with vehicle followed by red light illumination. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment | Posted | Number | participants | 4 weeks after last treatment, 6 weeks after baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Visonac Cream With PDT | PDT using MAL cream Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paraesthesia | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ashish Bhatia | Dermatology Institute | 630-942-5040 | acbhatia@gmail.com |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C475457 | methyl 5-aminolevulinate |
| C008848 | 1-phenyl-3,3-dimethyltriazene |
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| 4 weeks after last treatment, 6 weeks after baseline |
| Change in Noninflammatory Lesion Counts From Baseline | 4 weeks after last treatment, 6 weeks after baseline |
| Erythema Score (Mild and Moderate)Immediately After Second Treatment | Patients with mild or moderate erythema after second treatment. | Immediately after second treatment, 2 weeks after baseline |
| Erythema Score (Mild and Moderate)1 Day After First Treatment | Patients with mild or moderate erythema 1 day after first treatment. | 1 day after 1st treatment and baseline |
| Albuquerque |
| New Mexico |
| 87106 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Skin type | Skin type according to the Fitzpatrick Classification Scale. Skin type V: Brown, dark brown.Very rarely burns, tans very easily Skin type VI: Black, very dark brown to black. Never burns, tans very easily, deeply pigmented | Number | participants |
|
| Inflammatory lesions | Mean | Full Range | lesion |
|
| Non inflammatory lesions | Mean | Full Range | Lesion |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Erythema Score (Mild and Moderate)Immediately After First PDT | Patients with mild or moderate erythema after first treatment at baseline. | ITT | Posted | Number | percentage of participants | Immediately after treatment at baseline |
|
|
|
| Secondary | Change in Inflammatory Lesion Counts From Baseline | ITT | Posted | Mean | Standard Deviation | lesion count | 4 weeks after last treatment, 6 weeks after baseline |
|
|
|
| Secondary | Change in Noninflammatory Lesion Counts From Baseline | ITT | Posted | Mean | Standard Deviation | lesion count | 4 weeks after last treatment, 6 weeks after baseline |
|
|
|
| Secondary | Erythema Score (Mild and Moderate)Immediately After Second Treatment | Patients with mild or moderate erythema after second treatment. | ITT | Posted | Number | percentage of participants | Immediately after second treatment, 2 weeks after baseline |
|
|
|
| Secondary | Erythema Score (Mild and Moderate)1 Day After First Treatment | Patients with mild or moderate erythema 1 day after first treatment. | ITT | Posted | Number | percentage of participants | 1 day after 1st treatment and baseline |
|
|
|
| 0 |
| 20 |
| 12 |
| 20 |
| EG001 | Vehicle Cream With PDT | PDT using Placebo cream Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light | 0 | 20 | 12 | 20 |
| Erythema | Skin and subcutaneous tissue disorders |
|
| Pain of skin | Skin and subcutaneous tissue disorders |
|
| Pruritus nos | Skin and subcutaneous tissue disorders |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders |
|
| Skin warm | Skin and subcutaneous tissue disorders |
|
| Hematoma Nos | Vascular disorders | Non treatment site, included under both Visonac and vehicle arm |
|
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