Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT)

NCT00933543 | Completed Phase 2 Results

• 1 other identifier: PC TA204/09
• Study Type: interventional
• Target: 107
• Locations: 2 countries
• Sites: 11

Brief Summary

The purpose of this trial is to study the efficacy and safety of Visonac PDT in patients from 9 to 35 years old with Aktilite® CL512. Patients was randomized to Visonac or vehicle cream without occlusion and red light(dose: 37J/cm2)

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris; Moderate to severe

Outcome Measures

Primary Outcomes (3)

• Proportion of Patients With Success According to the Dichotomized IGA Scale Based on Facial Assessments 12 Weeks After the First Treatment. Success is Defined as an Improvement of at Least 2 Grades From the Baseline Score.

  12 weeks after the first treatment

• Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules)

  12 weeks after the first treatment

• Absolute Change From Baseline in Facial Non Inflammatory Lesion Count

  12 weeks after first treatment

Secondary Outcomes (23)

• Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count

  6 weeks after the first treatment

• Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Count

  12 weeks after the first treatment

• Percent Change From Baseline in Facial Non Inflammatory Lesion Count

  6 weeks after first treatment

• Percent Change From Baseline in Facial Non Inflammatory Lesion Count

  12 weeks after first treatment

• Percent Change From Baseline in Facial Total Lesion Count

  6 weeks after the first treatment

Study Arms (2)

Visonac cream with PDT

EXPERIMENTAL

Active treatment, Light dose 37 J/cm2.

Drug: Visonac PDT (MAL PDT); Procedure: PDT

Vehicle cream with PDT

PLACEBO COMPARATOR

Placebo treatment, Light dose 37 J/cm2.

Drug: Vehicle cream (placebo); Procedure: PDT

Interventions

Visonac PDT (MAL PDT) DRUG

Cream application followed by illumination with red light.

Also known as: Visonac, MAL PDT, red light

Visonac cream with PDT

Vehicle cream (placebo) DRUG

Cream application followed by illumination with red light.

Also known as: Vehicle cream, MAL PDT, red light

Vehicle cream with PDT

PDT PROCEDURE

Photodynamic Therapy - Light dose 37 J/cm2

Also known as: Red light

Vehicle cream with PDT; Visonac cream with PDT

Eligibility Criteria

• Age: 9 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female and male patients, above 9 years of age with moderate to severe facial acne vulgaris (IGA score 3-4).
• 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 6 months and must agree to stay with the same product and dose for an additional 6 months.
• Fitzpatrick skin type I through VI.
• Patients with 20 to 100 inflammatory lesions (papules, pustules, and nodules) on the face.
• Patients with 30 to 120 non-inflammatory lesions (open and closed comedones) on the face.
• Patients with no more than 2 nodular lesions on the face.
• Signed and verified informed consent form. For subjects under age of 18, an assent form in conjunction with an informed consent form, signed and verified by parent/guardian.

You may not qualify if:

• Patients presenting with any of the following will not be included in the study:
• 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 protocol.
• 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 using oral contraceptives, that have not used the same product or dose within the last 6 months and do not agree to stay with the same product and dose for the duration of the study.
• Pregnancy
• Patients undergoing testosterone or any other systemic hormonal treatment.
• Patients using hormonal contraceptives solely for the control of acne.
• Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.
• Patients with porphyria.
• Patients with cutaneous photosensitivity.
• Participation in other clinical studies either concurrently or within the last 30 days, before T1.
• Patients with a washout period for topical treatments e.g., topical BPOs, retinoids and antibiotics, for their acne of less than 14 days, before T1. Medicated cleansers may be used during the washout period and stopped before the treatment.
• Patients with a washout period for oral antibiotics for treatment of their acne of less than 1 month, before T1.
• Patients with a washout period for oral isotretinoin of less than 6 months, before T1.
• Patients with a beard or other facial hair that might interfere with study assessments.

Sponsors & Collaborators

• Photocure: lead

Study Sites (11)

Children's Specialists of San Diego / Rady Children's Hospital San Diego

San Diego, California, 92123, United States

Location

DeNova Research

Chicago, Illinois, 60611, United States

Location

Dermatology Institute of DuPage Medical Group

Naperville, Illinois, 60563, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Dermatology Associates of Rochester

Rochester, New York, 14623, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23507, United States

Location

Madison Skin & Research, Inc

Madison, Wisconsin, 53719, United States

Location

Windsor Clinical Research, Inc.

Windsor, Ontario N8W 5L7, Ontario, N8W 5L7, Canada

Location

INNOVADERM Research Inc.

Montreal, Quebec, Canada

Location

Centre de Recherche Dermatologique

Québec, Quebec, 2880, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Red Light; 1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Results Point of Contact

• Title: Project director Per Fuglerud
• Organization: Photocure

pf@photocure.no

+47 22 06 16 54

Study Officials

• Lawrence F. Eichenfield, M.D

  Children's Specialists of San Diego / Rady Children's Hospital San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 7, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: December 11, 2013
• Results First Posted: November 15, 2013

Record last verified: 2013-11

Locations

US (8); CA (3)