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

NCT ID: NCT01347879

Last Updated: 2014-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-05-31

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Visonac cream with PDT

active treatment with light dose of 37 Joule/cm2

Group Type: EXPERIMENTAL

Visonac PDT

Intervention Type: DRUG

cream application prior to illumination with red light

Vehicle cream with PDT

Placebo treatment, Light dose 37 Joule/cm2

Group Type: PLACEBO_COMPARATOR

Vehicle cream with PDT

Intervention Type: DRUG

placebo/vehicle cream application prior to illumination with red light

Interventions

Visonac PDT

cream application prior to illumination with red light

Intervention Type: DRUG

Vehicle cream with PDT

placebo/vehicle cream application prior to illumination with red light

Intervention Type: DRUG

Other Intervention Names

red light; red light

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.

• 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.

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).

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Photocure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Pariser, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Clinical Research, Inc.

Locations

Dermatology Specialists Inc

Oceanside, California, 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

Dermatology Institute, DuPage Medical Group

Naperville, Illinois, United States

Deaconess Clinic Inc

Evansville, Indiana, United States

ActivMed Practices & Research Inc

Haverhill, Massachusetts, United States

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Somerset Skin Centre

Troy, Michigan, United States

Penn State Hershey Medical Center

Hershey, Pennsylvania, 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

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Premier Clinical Research

Spokane, Washington, United States

Countries

United States

Other Identifiers

PCTA206/11

Identifier Type: -

Identifier Source: org_study_id