Clinical trial NCT01347879: A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi-center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: Acne vulgaris
PDT
Lead sponsor: Photocure
Sponsor class: INDUSTRY
First posted: 2011-05-04
Enrollment: 153
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).
timeFrame: From baseline to 12 weeks after first treatment
Secondary outcomes:
measure: Absolute Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)
timeFrame: From baseline to 12 weeks after the first treatment
measure: Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts.
timeFrame: From baseline to 12 weeks after the first treatment
measure: Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment.
timeFrame: From baseline to 12 weeks after first treatment
measure: Pain During Illumination.
timeFrame: Immediately after first treatment
measure: Number of Patients With Adverse Events.
timeFrame: From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration
measure: Erythema Score of Mild and Moderate
timeFrame: Immediately after first treatment
measure: Clear and Almost Clear Scarring According to Scarring Score
timeFrame: at week 12 after first treatment
measure: Percent Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)
timeFrame: From baseline to 12 weeks after first treatment
measure: Erythema Score of Severe
timeFrame: Immediately after first treatment
measure: Erythema Score of Mild and Moderate
timeFrame: 2 days after first treatment
measure: Erythema Score of Severe
timeFrame: 2 days after first treatment
measure: Mild and Moderate Scarring According to Scarring Score
timeFrame: at week 12 after first treatment
measure: Severe and Very Severe Scarring According to Scarring Score
timeFrame: at week 12 after first treatment
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Dermatology Specialists Inc
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates
state: Florida
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Naperville
country: United States
facility: Dermatology Institute, DuPage Medical Group
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic Inc
state: Indiana
city: Haverhill
country: United States
facility: ActivMed Practices & Research Inc
state: Massachusetts
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners LLC
state: Rhode Island
city: Austin
country: United States
facility: DermResearch Inc
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
affiliation: Virginia Clinical Research, Inc.
name: David Pariser, MD
role: PRINCIPAL_INVESTIGATOR
References: