A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi-center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
This study is intended to evaluate the efficacy and safety of Visonac Photodynamic Therapy (PDT) in patients with severe acne, score 4 on global IGA scale. The null hypothesis is that Visonac PDT is equal to vehicle PDT against the alternative hypothesis that Visonac PDT is different compared to vehicle PDT at week 12.

Official Title
-----------------
PCTA206/11 A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi Center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris.

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Visonac PDT
* Drug: Vehicle cream with PDT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and male patients, from 12-35 years of age with severe facial acne vulgaris (IGA score 4 on IGA scale) Signed and verified informed consent form and photo consent form. For subjects under age of 18, an assent form in conjunction with an informed consent form, signed and verified by parent/guardian. 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 3 months and must agree to stay with the same product and dose for an additional 3 months. Fitzpatrick skin type I through VI, Patients with 25 to 75 inflammatory lesions (papules, pustules, and nodules) on the face. Patients with 20 to 100 non-inflammatory lesions (open and closed comedones) on the face. Exclusion Criteria: Patients with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) Patients with more than 3 nodules on the face. 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 study. 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 with childbearing potential (i.e. ovulation, pre-menopausal, not surgically sterilized) and sexually active, not willing to use a medically accepted contraceptive regimen (as described under inclusion criteria) while on treatment. Pregnancy. Nursing. Participation in other clinical studies either currently or within the last 30 days. Patients with porphyria. Patients with cutaneous photosensitivity. Known allergy to MAL, to a similar PDT compound, or to excipients of the cream Patients using testosterone, any other systemic hormonal treatment or hormonal contraceptives solely for control of acne. Patients who have received topical treatments for their facial acne within the last 14 days (e.g steroids, retinoids, glycolic acid, benzoyl peroxide, anti inflammatory agents, antibiotics). Medicated cleansers may be used during the washout period and stopped before the treatment. Patients who have received oral antibiotics for treatment of their acne within the last month. Patients who have received oral isotretinoin within the last 6 months. Patient who have received facial procedures like dermabrasion, chemical or laser peels within the last 1 month. Patients using testosterone, any systemic hormonal treatment for other reasons than acne treatment and has not been on the same product and dose for at least 3 months Patients with moderate, severe or very severe facial acne scarring according to scarring scale described in section 10.4.3. Patients with a beard 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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visonac cream with PDT<br>active treatment with light dose of 37 Joule/cm2 | Drug: Visonac PDT<br>* cream application prior to illumination with red light<br>* Other names: red light;|
| Placebo Comparator: Vehicle cream with PDT<br>Placebo treatment, Light dose 37 Joule/cm2 | Drug: Vehicle cream with PDT<br>* placebo/vehicle cream application prior to illumination with red light<br>* Other names: red light;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules). |  | From baseline to 12 weeks after first treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones) |  | From baseline to 12 weeks after the first treatment | 
| Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts. |  | From baseline to 12 weeks after the first treatment | 
| Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment. | One Investigator Global Assessment (IGA) scale was used including inflammatory and non-inflammatory lesions. The investigator qualitatively graded the overall acne severity on a scale from 0 to 4, with 4 being the most severe. Success was defined as an improvement of at least 2 grades from the baseline score. | From baseline to 12 weeks after first treatment | 
| Pain During Illumination. | Pain during illumination was assessed by patient using a Visual Analogue Scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. | Immediately after first treatment | 
| Number of Patients With Adverse Events. |  | From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration | 
| Erythema Score of Mild and Moderate | Clinical assessment using a 4 point scale; none, mild, moderate, severe | Immediately after first treatment | 
| Clear and Almost Clear Scarring According to Scarring Score | Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe | at week 12 after first treatment | 
| Percent Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones) |  | From baseline to 12 weeks after first treatment | 
| Erythema Score of Severe | Clinical assessment using a 4 point scale; none, mild, moderate, severe | Immediately after first treatment | 
| Erythema Score of Mild and Moderate | Clinical assessment using a 4 point scale; none, mild, moderate, severe | 2 days after first treatment | 
| Erythema Score of Severe | Clinical assessment using a 4 point scale; none, mild, moderate, severe | 2 days after first treatment | 
| Mild and Moderate Scarring According to Scarring Score | Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe | at week 12 after first treatment | 
| Severe and Very Severe Scarring According to Scarring Score | Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe | at week 12 after first treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acne vulgaris, PDT