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The purpose of this trial is to study the efficacy and safety of Visonac PDT in patients from 9 to 35 years old with Aktilite® CL512. Patients was randomized to Visonac or vehicle cream without occlusion and red light(dose: 37J/cm2)
Double blinded, prospective, randomized, stratified, placebo-controlled, multi-center study in patients with moderate to severe acne vulgaris. Patients with facial severity grades 3 to 4 on the Investigator's Global Assessment (IGA) scale will be included. Each patient will be classified according to age in the two age groups 9 to 12 years and 13 to 35 years and randomized to either Visonac or vehicle cream within each age group. All patients will receive 4 treatments 2 weeks apart (at week 0, 2 ,4 and 6 week). Efficacy evaluation will be done after each treatment and at 12 weeks after the first treatment. Safety evaluations will be performed at each treatment visit and at 12 weeks after the first treatment.
Photographs of patients will be taken before and after treatment at first and last treatment visit, and at 12 weeks after first treatment.
Blood samples will be drawn at 3 visits; pre-treatment visit, one week after first treatment and at one week after last treatment visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visonac cream with PDT | Experimental | Active treatment, Light dose 37 J/cm2. |
|
| Vehicle cream with PDT | Placebo Comparator | Placebo treatment, Light dose 37 J/cm2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visonac PDT (MAL PDT) | Drug | Cream application followed by illumination with red light. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score. | 12 weeks after the first treatment | |
| Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules) | 12 weeks after the first treatment | |
| Absolute Change From Baseline in Facial Non Inflammatory Lesion Count | 12 weeks after first treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count | 6 weeks after the first treatment | |
| Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count | 12 weeks after the first treatment |
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Inclusion Criteria:
Exclusion Criteria:
Patients presenting with any of the following will not be included in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence F. Eichenfield, M.D | Children's Specialists of San Diego / Rady Children's Hospital San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Specialists of San Diego / Rady Children's Hospital San Diego | San Diego | California | 92123 | United States | ||
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Recruitment from September-December 2009. Dermatology clinics, with pediatric patients
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| ID | Title | Description |
|---|---|---|
| FG000 | Visonac Cream With PDT | Active treatment, Light dose 37 J/cm2. |
| FG001 | Vehicle Cream With PDT | Placebo treatment, Light dose 37 J/cm2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Visonac Cream With PDT | Active treatment, Light dose 37 J/cm2. |
| BG001 | Vehicle Cream With PDT | Placebo treatment, Light dose 37 J/cm2. |
| 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 Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score. | ITT | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the first treatment |
|
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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 | Active treatment, Light dose 37 J/cm2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project director Per Fuglerud | Photocure | +47 22 06 16 54 | pf@photocure.no |
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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 |
|---|---|
| D000095742 | Red Light |
| C008848 | 1-phenyl-3,3-dimethyltriazene |
| ID | Term |
|---|---|
| D008027 | Light |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
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| Vehicle cream (placebo) | Drug | Cream application followed by illumination with red light. |
|
|
| PDT | Procedure | Photodynamic Therapy - Light dose 37 J/cm2 |
|
|
| Percent Change From Baseline in Facial Non Inflammatory Lesion Count | 6 weeks after first treatment |
| Percent Change From Baseline in Facial Non Inflammatory Lesion Count | 12 weeks after first treatment |
| Percent Change From Baseline in Facial Total Lesion Count | 6 weeks after the first treatment |
| Percent Change From Baseline in Facial Total Lesion Count | 12 weeks after the first treatment |
| Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Non-inflammatory Lesion Count | 12 weeks after last treatment |
| Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Inflammatory Lesion Count From Baseline | 12 weeks after first treatment |
| Absolute Change From Baseline in Facial Inflammatory Lesion Count | 6 weeks after the first treatment |
| Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count | 6 weeks after the first treatment |
| Absolute Change From Baseline in Facial Total Lesion Count | 6 weeks after the first treatment |
| Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score. | 6 weeks after the first treatment |
| Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable | Facial pain was assessed on a visual analogue scale ranging from 0-10cm. | directly after first treatment |
| Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable | Facial pain was assessed on a visual analogue scale ranging from 0-10cm. | directly after second treatment |
| Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable | Facial pain was assessed on a visual analogue scale ranging from 0-10cm. | directly after third treatment |
| Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable | Facial pain was assessed on a visual analogue scale ranging from 0-10cm. | directly after fourth treatment |
| Proportion of Patients With Mild and Moderate Hyperpigmentation | at 12 weeks after first treatment |
| Proportion of Patients With Severe Hyperpigmentation | at 12 weeks after first treatment |
| Proportion of Patients With Mild or Moderate Scarring at End of Study | week 12 |
| Proportion of Patients With Clear or Almost Clear Scarring at End of Study | week 12 |
| Proportion of Patients With Severe and Very Severe Scarring at End of Study | week 12 |
| Proportion of Patients With Hypopigmentation (Mild Moderate, Severe) | at 12 weeks after first treatment |
| Proportion of Patients With Dryness (Mild) | at 12 weeks after first treatment |
| DeNova Research |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Dermatology Institute of DuPage Medical Group | Naperville | Illinois | 60563 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Dermatology Associates of Rochester | Rochester | New York | 14623 | United States |
| Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | United States |
| Madison Skin & Research, Inc | Madison | Wisconsin | 53719 | United States |
| Windsor Clinical Research, Inc. | Windsor, Ontario N8W 5L7 | Ontario | N8W 5L7 | Canada |
| INNOVADERM Research Inc. | Montreal | Quebec | Canada |
| Centre de Recherche Dermatologique | Québec | Quebec | 2880 | Canada |
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Other |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Patients with mild and moderate hyperpigmentation | Number | number of patients |
|
| Investigator Global Assessment (IGA) Score | Number | participants |
|
| Fitzpatrick Skin type | I: White; very fair; red or blond hair; blue eyes; freckles Always burns, never tans II: White; fair; red or blond hair; blue, hazel or green eyes Usually burns, tans with difficulty III: Cream white; fair with any eye or hair color; very common Sometimes mild burn, gradually tans IV: Brown; typical Mediterranean Caucasian skin Rarely burns, tans with ease V: Dark brown; Middle Eastern skin types Very rarely burns, tans very easily VI: Black Never burns, tans very easily | Number | participants |
|
| Scarring | The investigator assess the scarring using a scale called SCAR-S. Clear 0: No visible scars from acne. Almost clear 1: Hardly visible scars from 2.5 meters away. Mild 2: Easily recognizable, less than ½ the affected area (eg. face, back or chest) involved. Moderate 3: More than ½ affected area (eg. face, back or chest) involved. Severe 4: Entire area involved. Very severe 5: Entire area with prominent atrophic or hypertrophic scars. | Number | number of patients |
|
| Patients with dryness | The investigator assess the dryness using a scale from 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). | Number | Number of patients |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count | ITT | Posted | Mean | Standard Deviation | percent change from baseline | 6 weeks after the first treatment |
|
|
|
| Primary | Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules) | ITT | Posted | Mean | Standard Deviation | lesions | 12 weeks after the first treatment |
|
|
|
|
| Primary | Absolute Change From Baseline in Facial Non Inflammatory Lesion Count | ITT | Posted | Mean | Standard Deviation | lesions | 12 weeks after first treatment |
|
|
|
|
| Secondary | Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count | ITT | Posted | Mean | Standard Deviation | Percent change from baseline | 12 weeks after the first treatment |
|
|
|
| Secondary | Percent Change From Baseline in Facial Non Inflammatory Lesion Count | ITT | Posted | Mean | Standard Deviation | percentage change from baseline | 6 weeks after first treatment |
|
|
|
| Secondary | Percent Change From Baseline in Facial Non Inflammatory Lesion Count | ITT | Posted | Mean | Standard Deviation | percentage change from baseline | 12 weeks after first treatment |
|
|
|
| Secondary | Percent Change From Baseline in Facial Total Lesion Count | ITT | Posted | Mean | Standard Deviation | Percent change from baseline | 6 weeks after the first treatment |
|
|
|
| Secondary | Percent Change From Baseline in Facial Total Lesion Count | ITT | Posted | Mean | Standard Deviation | Percent change from baseline | 12 weeks after the first treatment |
|
|
|
| Secondary | Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Non-inflammatory Lesion Count | ITT | Posted | Number | participants | 12 weeks after last treatment |
|
|
|
| Secondary | Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Inflammatory Lesion Count From Baseline | Posted | Number | participants | 12 weeks after first treatment |
|
|
|
| Secondary | Absolute Change From Baseline in Facial Inflammatory Lesion Count | ITT | Posted | Mean | Standard Deviation | lesions | 6 weeks after the first treatment |
|
|
|
| Secondary | Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count | ITT | Posted | Mean | Standard Deviation | lesions | 6 weeks after the first treatment |
|
|
|
| Secondary | Absolute Change From Baseline in Facial Total Lesion Count | ITT | Posted | Mean | Standard Deviation | lesions | 6 weeks after the first treatment |
|
|
|
| Secondary | Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score. | ITT | Posted | Number | Participants | 6 weeks after the first treatment |
|
|
|
| Secondary | Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable | Facial pain was assessed on a visual analogue scale ranging from 0-10cm. | Safety population | Posted | Mean | Full Range | cm | directly after first treatment |
|
|
|
| Secondary | Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable | Facial pain was assessed on a visual analogue scale ranging from 0-10cm. | Safety population | Posted | Mean | Full Range | cm | directly after second treatment |
|
|
|
| Secondary | Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable | Facial pain was assessed on a visual analogue scale ranging from 0-10cm. | Safety population | Posted | Mean | Full Range | cm | directly after third treatment |
|
|
|
| Secondary | Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable | Facial pain was assessed on a visual analogue scale ranging from 0-10cm. | Safety population | Posted | Mean | Full Range | cm | directly after fourth treatment |
|
|
|
| Secondary | Proportion of Patients With Mild and Moderate Hyperpigmentation | Safety | Posted | Number | participants | at 12 weeks after first treatment |
|
|
|
| Secondary | Proportion of Patients With Severe Hyperpigmentation | Safety | Posted | Number | participants | at 12 weeks after first treatment |
|
|
|
| Secondary | Proportion of Patients With Mild or Moderate Scarring at End of Study | Posted | Number | participants | week 12 |
|
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|
| Secondary | Proportion of Patients With Clear or Almost Clear Scarring at End of Study | Posted | Number | participants | week 12 |
|
|
|
| Secondary | Proportion of Patients With Severe and Very Severe Scarring at End of Study | Posted | Number | participants | week 12 |
|
|
|
| Secondary | Proportion of Patients With Hypopigmentation (Mild Moderate, Severe) | Safety | Posted | Number | participants | at 12 weeks after first treatment |
|
|
|
| Secondary | Proportion of Patients With Dryness (Mild) | Safety | Posted | Number | participants | at 12 weeks after first treatment |
|
|
|
| 0 |
| 54 |
| 46 |
| 54 |
| EG001 | Vehicle Cream With PDT | Placebo treatment, Light dose 37 J/cm2. | 0 | 53 | 32 | 53 |
| Pruritus | Skin and subcutaneous tissue disorders |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders |
|
| Skin irritation | Skin and subcutaneous tissue disorders |
|
| Pain | General disorders |
|
| Facial pain | General disorders |
|
| Feeling hot | General disorders |
|
| Nasopharyngitis | Infections and infestations |
|
| Paraestehesia | Nervous system disorders |
|
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| D055585 |
| Physical Phenomena |
| D055620 | Optical Phenomena |
| D011827 | Radiation |
| D011840 | Radiation, Nonionizing |