Acne Vulgaris
Conditions
Brief summary
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.
Detailed description
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
Interventions
Cream application followed by illumination with red light
Sponsors
Photocure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Female and male patients, age 15 to 40 years with acne vulgaris. 2. Patients with skin type V or VI (Fitzpatrick). 3. Patients with two areas of each 8x8 cm2 on the back that include at least 5 inflammatory lesions (papules, pustules, and nodules) each. The minimum distance between the two areas should be at least 4 cm. 4. Patients with no more than 2 nodular lesions in any of the two areas of each 8x8 cm2 on the back. 5. Patients who are surgically sterile, 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 Day 0. Patients using birth control pills must have used the same product and dose for at least 3 months and must agree to stay with the same product and dose for an additional 3 months. 6. Patients must be willing and capable of following study instructions to the extent and degree required by the protocol. 7. Patients must sign the approved informed consent form prior to any study procedures. 8. Patients must be willing to be photographed. Patients must be willing to sign a photography consent form.
Exclusion criteria
1. Known allergy to MAL, to a similar PDT compound, or to excipients of the cream. 2. Participation in other clinical studies either concurrently or within the last 30 days. 3. Patients who have a condition or who are in a situation, which, in the investigator's opinion, may put the patient at risk, may confound the study results, or may interfere with the patient's participation in the study. 4. Clinically significant sensitivity to visible light, or has porphyria or porphyrin sensitivity. 5. Exposure to ultraviolet radiation (UVB phototherapy) within the last 30 days. 6. Patients with a washout period for topical treatments for their acne in the two treatment areas of less than 14 days. Any topical treatment on the face or other areas outside the two treatment areas will be allowed. 7. Patients with a washout period for oral antibiotics for treatment of their acne of less than 1 month. 8. Patients with a washout period for oral isotretinoin of less than 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment | 4 weeks after last treatment, 6 weeks after baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erythema Score (Mild and Moderate)Immediately After First PDT | Immediately after treatment at baseline | Patients with mild or moderate erythema after first treatment at baseline. |
| Change in Inflammatory Lesion Counts From Baseline | 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 | Immediately after second treatment, 2 weeks after baseline | Patients with mild or moderate erythema after second treatment. |
| Erythema Score (Mild and Moderate)1 Day After First Treatment | 1 day after 1st treatment and baseline | Patients with mild or moderate erythema 1 day after first treatment. |
Countries
United States
Participant flow
Pre-assignment details
Two areas on the back per patient was treated, one area with Visonac and one with vehicle
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Visonac and Vehicle Cream With PDT |
|---|---|
| Age, Categorical <=18 years | 4 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Inflammatory lesions vehicle treated area | 6.0 lesion |
| Inflammatory lesions Visonac treated area | 5.9 lesion |
| Non inflammatory lesions vehicle treated area | 5.4 Lesion |
| Non inflammatory lesions Visonac treated area | 6.5 Lesion |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 11 Participants |
| Skin type Skin type V | 18 participants |
| Skin type Skin type VI | 2 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 20 | 12 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment
Time frame: 4 weeks after last treatment, 6 weeks after baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Visonac Cream With PDT | Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment | 0 participants |
| Vehicle Cream With PDT | Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment | 0 participants |
Secondary
Change in Inflammatory Lesion Counts From Baseline
Time frame: 4 weeks after last treatment, 6 weeks after baseline
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visonac Cream With PDT | Change in Inflammatory Lesion Counts From Baseline | -3.70 lesion count | Standard Deviation 2.43 |
| Vehicle Cream With PDT | Change in Inflammatory Lesion Counts From Baseline | -3.90 lesion count | Standard Deviation 2.07 |
Secondary
Change in Noninflammatory Lesion Counts From Baseline
Time frame: 4 weeks after last treatment, 6 weeks after baseline
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Visonac Cream With PDT | Change in Noninflammatory Lesion Counts From Baseline | -2.95 lesion count | Standard Deviation 4.84 |
| Vehicle Cream With PDT | Change in Noninflammatory Lesion Counts From Baseline | -2.50 lesion count | Standard Deviation 2.65 |
Secondary
Erythema Score (Mild and Moderate)1 Day After First Treatment
Patients with mild or moderate erythema 1 day after first treatment.
Time frame: 1 day after 1st treatment and baseline
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Visonac Cream With PDT | Erythema Score (Mild and Moderate)1 Day After First Treatment | 0 percentage of participants |
| Vehicle Cream With PDT | Erythema Score (Mild and Moderate)1 Day After First Treatment | 0 percentage of participants |
Secondary
Erythema Score (Mild and Moderate)Immediately After First PDT
Patients with mild or moderate erythema after first treatment at baseline.
Time frame: Immediately after treatment at baseline
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Visonac Cream With PDT | Erythema Score (Mild and Moderate)Immediately After First PDT | 10.5 percentage of participants |
| Vehicle Cream With PDT | Erythema Score (Mild and Moderate)Immediately After First PDT | 0.0 percentage of participants |
Secondary
Erythema Score (Mild and Moderate)Immediately After Second Treatment
Patients with mild or moderate erythema after second treatment.
Time frame: Immediately after second treatment, 2 weeks after baseline
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Visonac Cream With PDT | Erythema Score (Mild and Moderate)Immediately After Second Treatment | 11.1 percentage of participants |
| Vehicle Cream With PDT | Erythema Score (Mild and Moderate)Immediately After Second Treatment | 0 percentage of participants |