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

Phase 2

Completed

Conditions: Acne Vulgaris

Interventions: Drug: Vehicle cream with PDT
Drug: Visonac PDT

Registration Number: NCT01347879

Lead Sponsor: Photocure

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 153

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle cream with PDT	Vehicle cream with PDT	Placebo treatment, Light dose 37 Joule/cm2
Visonac cream with PDT	Visonac PDT	active treatment with light dose of 37 Joule/cm2

Primary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).	From baseline to 12 weeks after first treatment

Secondary Outcome Measures

Name	Time	Method
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.	From baseline to 12 weeks after first treatment	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.
Pain During Illumination.	Immediately after first treatment	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.
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	2 days after first treatment	Clinical assessment using a 4 point scale; none, mild, moderate, severe
Clear and Almost Clear Scarring According to Scarring Score	at week 12 after first treatment	Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
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	2 days after first treatment	Clinical assessment using a 4 point scale; none, mild, moderate, severe
Mild and Moderate Scarring According to Scarring Score	at week 12 after first treatment	Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe
Severe and Very Severe Scarring According to Scarring Score	at week 12 after first treatment	Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe

Trial Locations

Locations (15): Dermatology Specialists Inc
🇺🇸
Oceanside, California, United States
Dermatology Institute, DuPage Medical Group
🇺🇸
Naperville, Illinois, United States
Virginia Clinical Research, Inc.
🇺🇸
Norfolk, Virginia, United States
Rady Children's Hospital
🇺🇸
San Diego, California, United States
North Florida Dermatology Associates
🇺🇸
Jacksonville, Florida, United States
Altman Dermatology Associates
🇺🇸
Arlington Heights, Illinois, United States
Deaconess Clinic Inc
🇺🇸
Evansville, Indiana, United States
Hamzavi Dermatology
🇺🇸
Fort Gratiot, Michigan, United States
Somerset Skin Centre
🇺🇸
Troy, Michigan, United States
Clinical Partners LLC
🇺🇸
Johnston, Rhode Island, United States
DermResearch Inc
🇺🇸
Austin, Texas, United States
Clinical Trials of Texas
🇺🇸
San Antonio, Texas, United States
Premier Clinical Research
🇺🇸
Spokane, Washington, United States
Penn State Hershey Medical Center
🇺🇸
Hershey, Pennsylvania, United States
ActivMed Practices & Research Inc
🇺🇸
Haverhill, Massachusetts, United States