Acne Vulgaris
Conditions
Keywords
Acne Vulgaris, Moderate to severe
Brief summary
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)
Detailed description
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.
Interventions
DRUGVisonac PDT (MAL PDT)
Cream application followed by illumination with red light.
Cream application followed by illumination with red light.
PROCEDUREPDT
Photodynamic Therapy - Light dose 37 J/cm2
Sponsors
Photocure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Female and male patients, above 9 years of age with moderate to severe facial acne vulgaris (IGA score 3-4). * Female patients who are surgically sterile, pre-menstrual, postmenopausal, abstinent, or willing to use an adequate means of contraception including birth control pills, or barrier methods and spermicide for at least 14 days prior to T1. Patients using birth control pills must have used the same product and dose for at least 6 months and must agree to stay with the same product and dose for an additional 6 months. * Fitzpatrick skin type I through VI. * Patients with 20 to 100 inflammatory lesions (papules, pustules, and nodules) on the face. * Patients with 30 to 120 non-inflammatory lesions (open and closed comedones) on the face. * Patients with no more than 2 nodular lesions on the face. * Signed and verified informed consent form. For subjects under age of 18, an assent form in conjunction with an informed consent form, signed and verified by parent/guardian.
Exclusion criteria
Patients presenting with any of the following will not be included in the study: * Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol. * Patients unlikely to comply with the protocol, e.g., mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the clinical study, uncooperative attitude or unlikelihood of completing the study (e.g., drug or alcohol abuse). * Female patients using oral contraceptives, that have not used the same product or dose within the last 6 months and do not agree to stay with the same product and dose for the duration of the study. * Pregnancy * Patients undergoing testosterone or any other systemic hormonal treatment. * Patients using hormonal contraceptives solely for the control of acne. * Known allergy to MAL, to a similar PDT compound, or to excipients of the cream. * Patients with porphyria. * Patients with cutaneous photosensitivity. * Participation in other clinical studies either concurrently or within the last 30 days, before T1. * Patients with a washout period for topical treatments e.g., topical BPOs, retinoids and antibiotics, for their acne of less than 14 days, before T1. Medicated cleansers may be used during the washout period and stopped before the treatment. * Patients with a washout period for oral antibiotics for treatment of their acne of less than 1 month, before T1. * Patients with a washout period for oral isotretinoin of less than 6 months, before T1. * Patients with a beard or other facial hair that might interfere with study assessments. * Patients with melanoma or dysplastic nevi in the treatment area. * Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within the last 30 days. * Exposure to PDT within 12 weeks before T1.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | directly after first treatment | Facial pain was assessed on a visual analogue scale ranging from 0-10cm. |
| Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count | 6 weeks after the 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 | — |
| Proportion of Patients With Mild and Moderate Hyperpigmentation | at 12 weeks after first treatment | — |
| Percent Change From Baseline in Facial Non Inflammatory Lesion Count | 6 weeks after first treatment | — |
| Percent Change From Baseline in Facial Total Lesion Count | 6 weeks after the first treatment | — |
Countries
Canada, United States
Participant flow
Recruitment details
Recruitment from September-December 2009. Dermatology clinics, with pediatric patients
Participants by arm
| Arm | Count |
|---|---|
| Visonac Cream With PDT Active treatment, Light dose 37 J/cm2. | 54 |
| Vehicle Cream With PDT Placebo treatment, Light dose 37 J/cm2. | 53 |
| Total | 107 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lack of Efficacy | 0 | 3 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Other | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Vehicle Cream With PDT | Visonac Cream With PDT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 34 Participants | 35 Participants | 69 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 19 Participants | 38 Participants |
| Fitzpatrick Skin type Skin type I | 6 participants | 5 participants | 11 participants |
| Fitzpatrick Skin type Skin type II | 15 participants | 14 participants | 29 participants |
| Fitzpatrick Skin type Skin type III | 21 participants | 24 participants | 45 participants |
| Fitzpatrick Skin type Skin type IV | 6 participants | 4 participants | 10 participants |
| Fitzpatrick Skin type Skin type V | 2 participants | 5 participants | 7 participants |
| Fitzpatrick Skin type Skin type VI | 3 participants | 2 participants | 5 participants |
| Investigator Global Assessment (IGA) Score IGA 3 (Moderate acne) | 45 participants | 44 participants | 89 participants |
| Investigator Global Assessment (IGA) Score IGA 4 (Severe acne) | 8 participants | 10 participants | 18 participants |
| Patients with dryness Mild dryness | 7 Number of patients | 9 Number of patients | 16 Number of patients |
| Patients with dryness No dryness | 46 Number of patients | 45 Number of patients | 91 Number of patients |
| Patients with mild and moderate hyperpigmentation Mild hyperpigmentation | 10 number of patients | 5 number of patients | 15 number of patients |
| Patients with mild and moderate hyperpigmentation Moderate hyperpigmentation | 8 number of patients | 8 number of patients | 16 number of patients |
| Patients with mild and moderate hyperpigmentation No hyperpigmentation | 34 number of patients | 39 number of patients | 73 number of patients |
| Patients with mild and moderate hyperpigmentation Severe hyperpigmentation | 1 number of patients | 2 number of patients | 3 number of patients |
| Region of Enrollment Canada | 16 participants | 17 participants | 33 participants |
| Region of Enrollment United States | 37 participants | 37 participants | 74 participants |
| Scarring Patients with almost clear scarring | 10 number of patients | 9 number of patients | 19 number of patients |
| Scarring Patients with mild scarring | 9 number of patients | 15 number of patients | 24 number of patients |
| Scarring Patients with moderate scarring | 6 number of patients | 6 number of patients | 12 number of patients |
| Scarring Patients with no scarring | 26 number of patients | 21 number of patients | 47 number of patients |
| Scarring Patients with severe scarring | 1 number of patients | 3 number of patients | 4 number of patients |
| Scarring Patients with very severe scarring | 1 number of patients | 0 number of patients | 1 number of patients |
| Sex: Female, Male Female | 27 Participants | 32 Participants | 59 Participants |
| Sex: Female, Male Male | 26 Participants | 22 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 46 / 54 | 32 / 53 |
| serious Total, serious adverse events | 0 / 54 | 0 / 53 |
Outcome results
Primary
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules)
Time frame: 12 weeks after the first treatment
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visonac Cream With PDT | Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules) | -14.0 lesions | Standard Deviation 17.94 |
| Vehicle Cream With PDT | Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules) | -13.8 lesions | Standard Deviation 23.76 |
Comparison: H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)p-value: 0.296995% CI: [-11.35, 3.5]ANCOVA
Primary
Absolute Change From Baseline in Facial Non Inflammatory Lesion Count
Time frame: 12 weeks after first treatment
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visonac Cream With PDT | Absolute Change From Baseline in Facial Non Inflammatory Lesion Count | -14.3 lesions | Standard Deviation 26.54 |
| Vehicle Cream With PDT | Absolute Change From Baseline in Facial Non Inflammatory Lesion Count | -17.1 lesions | Standard Deviation 25.84 |
Comparison: H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)p-value: 0.891395% CI: [-9.09, 10.43]ANCOVA
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.
Time frame: 12 weeks after the first treatment
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Visonac Cream With PDT | 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. | 9.26 percentage of participants |
| Vehicle Cream With PDT | 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. | 1.89 percentage of participants |
Comparison: H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)p-value: 0.070395% CI: [0.65, 63.18]Cochran-Mantel-Haenszel
Secondary
Absolute Change From Baseline in Facial Inflammatory Lesion Count
Time frame: 6 weeks after the first treatment
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visonac Cream With PDT | Absolute Change From Baseline in Facial Inflammatory Lesion Count | -17.5 lesions | Standard Deviation 9 |
| Vehicle Cream With PDT | Absolute Change From Baseline in Facial Inflammatory Lesion Count | -10.8 lesions | Standard Deviation 22.41 |
Secondary
Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count
Time frame: 6 weeks after the first treatment
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visonac Cream With PDT | Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count | 12.9 lesions | Standard Deviation 21.41 |
| Vehicle Cream With PDT | Absolute Change From Baseline in Facial Non- Inflammatory Lesion Count | 11.3 lesions | Standard Deviation 28.24 |
Secondary
Absolute Change From Baseline in Facial Total Lesion Count
Time frame: 6 weeks after the first treatment
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visonac Cream With PDT | Absolute Change From Baseline in Facial Total Lesion Count | -27.2 lesions | Standard Deviation 26.19 |
| Vehicle Cream With PDT | Absolute Change From Baseline in Facial Total Lesion Count | -20.6 lesions | Standard Deviation 36.68 |
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.
Time frame: directly after second treatment
Population: Safety population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Visonac Cream With PDT | Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable | 1.37 cm |
| Vehicle Cream With PDT | Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable | 0.15 cm |
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.
Time frame: directly after fourth treatment
Population: Safety population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Visonac Cream With PDT | Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable | 1.39 cm |
| Vehicle Cream With PDT | Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable | 0.19 cm |
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.
Time frame: directly after third treatment
Population: Safety population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Visonac Cream With PDT | Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable | 1.53 cm |
| Vehicle Cream With PDT | Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable | 0.17 cm |
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.
Time frame: directly after first treatment
Population: Safety population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visonac Cream With PDT | Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable | 1.5 cm | Full Range 2.2 |
| Vehicle Cream With PDT | Facial Pain Assessed Using a Visual Analogue Scale From 0 to 10, Where 0 Indicates no Pain and 10 Indicates Worst Pain Imaginable | 0.28 cm | Full Range 0.64 |
Secondary
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count
Time frame: 6 weeks after the first treatment
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visonac Cream With PDT | Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count | -35.4 percent change from baseline | Standard Deviation 30.85 |
| Vehicle Cream With PDT | Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count | -20.3 percent change from baseline | Standard Deviation 38.72 |
Secondary
Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count
Time frame: 12 weeks after the first treatment
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visonac Cream With PDT | Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count | -33.1 Percent change from baseline | Standard Deviation 39.34 |
| Vehicle Cream With PDT | Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count | -27.5 Percent change from baseline | Standard Deviation 44.38 |
Secondary
Percent Change From Baseline in Facial Non Inflammatory Lesion Count
Time frame: 6 weeks after first treatment
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visonac Cream With PDT | Percent Change From Baseline in Facial Non Inflammatory Lesion Count | -25.3 percentage change from baseline | Standard Deviation 39.72 |
| Vehicle Cream With PDT | Percent Change From Baseline in Facial Non Inflammatory Lesion Count | -15.8 percentage change from baseline | Standard Deviation 47.11 |
Secondary
Percent Change From Baseline in Facial Non Inflammatory Lesion Count
Time frame: 12 weeks after first treatment
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visonac Cream With PDT | Percent Change From Baseline in Facial Non Inflammatory Lesion Count | -26.0 percentage change from baseline | Standard Deviation 52.23 |
| Vehicle Cream With PDT | Percent Change From Baseline in Facial Non Inflammatory Lesion Count | -24.4 percentage change from baseline | Standard Deviation 37.66 |
Secondary
Percent Change From Baseline in Facial Total Lesion Count
Time frame: 6 weeks after the first treatment
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visonac Cream With PDT | Percent Change From Baseline in Facial Total Lesion Count | -29.5 Percent change from baseline | Standard Deviation 27.72 |
| Vehicle Cream With PDT | Percent Change From Baseline in Facial Total Lesion Count | -18.0 Percent change from baseline | Standard Deviation 35.39 |
Secondary
Percent Change From Baseline in Facial Total Lesion Count
Time frame: 12 weeks after the first treatment
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visonac Cream With PDT | Percent Change From Baseline in Facial Total Lesion Count | -29.8 Percent change from baseline | Standard Deviation 36.04 |
| Vehicle Cream With PDT | Percent Change From Baseline in Facial Total Lesion Count | -26.8 Percent change from baseline | Standard Deviation 29.61 |
Secondary
Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Inflammatory Lesion Count From Baseline
Time frame: 12 weeks after first treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Visonac Cream With PDT | Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Inflammatory Lesion Count From Baseline | 20 participants |
| Vehicle Cream With PDT | Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Inflammatory Lesion Count From Baseline | 19 participants |
Secondary
Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Non-inflammatory Lesion Count
Time frame: 12 weeks after last treatment
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Visonac Cream With PDT | Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Non-inflammatory Lesion Count | 17 participants |
| Vehicle Cream With PDT | Proportion of Patients With a Reduction of at Least 50% From Baseline in Facial Non-inflammatory Lesion Count | 10 participants |
Secondary
Proportion of Patients With Clear or Almost Clear Scarring at End of Study
Time frame: week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Visonac Cream With PDT | Proportion of Patients With Clear or Almost Clear Scarring at End of Study | 59 participants |
| Vehicle Cream With PDT | Proportion of Patients With Clear or Almost Clear Scarring at End of Study | 63 participants |
Secondary
Proportion of Patients With Dryness (Mild)
Time frame: at 12 weeks after first treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Visonac Cream With PDT | Proportion of Patients With Dryness (Mild) | 20 participants |
| Vehicle Cream With PDT | Proportion of Patients With Dryness (Mild) | 16 participants |
Secondary
Proportion of Patients With Hypopigmentation (Mild Moderate, Severe)
Time frame: at 12 weeks after first treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Visonac Cream With PDT | Proportion of Patients With Hypopigmentation (Mild Moderate, Severe) | 0 participants |
| Vehicle Cream With PDT | Proportion of Patients With Hypopigmentation (Mild Moderate, Severe) | 0 participants |
Secondary
Proportion of Patients With Mild and Moderate Hyperpigmentation
Time frame: at 12 weeks after first treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Visonac Cream With PDT | Proportion of Patients With Mild and Moderate Hyperpigmentation | 26 participants |
| Vehicle Cream With PDT | Proportion of Patients With Mild and Moderate Hyperpigmentation | 32 participants |
Secondary
Proportion of Patients With Mild or Moderate Scarring at End of Study
Time frame: week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Visonac Cream With PDT | Proportion of Patients With Mild or Moderate Scarring at End of Study | 36 participants |
| Vehicle Cream With PDT | Proportion of Patients With Mild or Moderate Scarring at End of Study | 34 participants |
Secondary
Proportion of Patients With Severe and Very Severe Scarring at End of Study
Time frame: week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Visonac Cream With PDT | Proportion of Patients With Severe and Very Severe Scarring at End of Study | 6 participants |
| Vehicle Cream With PDT | Proportion of Patients With Severe and Very Severe Scarring at End of Study | 2 participants |
Secondary
Proportion of Patients With Severe Hyperpigmentation
Time frame: at 12 weeks after first treatment
Population: Safety
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Visonac Cream With PDT | Proportion of Patients With Severe Hyperpigmentation | 1 participants |
| Vehicle Cream With PDT | Proportion of Patients With Severe Hyperpigmentation | 0 participants |
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.
Time frame: 6 weeks after the first treatment
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Visonac Cream With PDT | 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. | 3 Participants |
| Vehicle Cream With PDT | 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. | 1 Participants |