Light Dose Ranging Study of Photodynamic Therapy (PDT) With Levulan + Blue Light Versus Vehicle + Blue Light in Severe Facial Acne

NCT00706433 | Completed Phase 2 Results

• 1 other identifier: DUSA-CP0103
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to determine and compare the safety and efficacy of multiple broad area photodynamic therapy treatments with aminolevulinic acid (ALA-PDT) and vehicle (VEH-PDT) in subjects with moderate to severe facial acne vulgaris.

Conditions

Acne Vulgaris

Keywords

Photodynamic Therapy

Outcome Measures

Primary Outcomes (2)

• Change in Inflammatory Lesion Counts Relative to Baseline

  Baseline and 3 weeks after final treatment

• Investigator Global Assessment of Acne Severity Successes

  Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline.

  Baseline and 3 weeks after final treatment

Secondary Outcomes (75)

• Percent Change in Inflammatory Lesion Counts Relative to Baseline

  Baseline and 3 weeks after final treatment

• Percent Change in Inflammatory Lesion Counts Relative to Baseline

  Baseline and 6 weeks after final treatment

• Subject Satisfaction Score

  6 weeks after final treatment

• Change in Inflammatory Lesion Counts Relative to Baseline

  Baseline and 6 weeks after final treatment

• Investigator Global Assessment of Acne Severity Successes

  Baesline and 6 weeks after final treatment

Study Arms (4)

ALA 1000 seconds

ACTIVE COMPARATOR

Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)

Drug: aminolevulinic acid HCL (ALA)

ALA 500 seconds

ACTIVE COMPARATOR

Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds)

Drug: aminolevulinic acid HCL (ALA)

Vehicle 1000 seconds

PLACEBO COMPARATOR

Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds)

Other: Vehicle (VEH)

Vehicle 500 seconds

PLACEBO COMPARATOR

Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)

Other: Vehicle (VEH)

Interventions

aminolevulinic acid HCL (ALA) DRUG

Levulan Kerastick containing 20% aminolevulinic acid HCL (ALA). Up to 4 treatments will be given at 3 week intervals.

Also known as: Levulan, Levulan Kerastick

ALA 1000 seconds; ALA 500 seconds

Vehicle (VEH) OTHER

Levulan Kerastick containing vehicle ingredients only (VEH). Up to 4 treatments will be given at 3 week intervals.

Vehicle 1000 seconds; Vehicle 500 seconds

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or non-pregnant female 12 years of age or older.
• Females must be post-menopausal, surgically sterile or using a medically acceptable form of birth control, with a negative urine pregnancy test at the Baseline visit.
• Subject has provided written and verbal informed consent. A subject under 18 years of age must be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must also provide informed consent for the subject.
• Subject has moderate to severe facial acne vulgaris (including the nose), with at least 20 inflammatory lesions (papules, pustules, nodules).
• Subject has moderate to severe acne as defined by an Investigator Global Assessment of 3 or 4 \[0 (clear) to 4 (severe) scale\].
• Subject has a history of recurrent herpes simplex labialis infection in the treatment area AND has had an outbreak within the last 12 months must be placed on antiviral prophylaxis as specified in the protocol.
• Subject is willing to comply with study instructions and return to the clinic for required visits.
• Subject must have used the same type and brand of make-up, other facial products and hair products (e.g. shampoo, gel, hair spray, mousse, etc.) for at least 1 month prior to the Baseline Visit (General Skin \& Hair Care). Upon enrollment, all subjects must a) use exclusively an Investigator approved facial cleanser and b) agree to continue their other General Skin \& Hair Care for the entire study.

You may not qualify if:

• Subject is pregnant, lactating, or is planning to become pregnant during the study.
• Subject has a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis.
• Subject has any skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy.
• Subject has greater than 4 facial nodules (nodule = lesion greater than or equal 0.5 cm in diameter)
• Subject has an uncorrected coagulation defect or concurrently uses anticoagulants (except aspirin).
• Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
• Subject is currently enrolled in an investigational drug or device study.
• Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment (baseline).
• Subject has facial hair that could interfere with the study assessments in the opinion of the investigator.
• Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
• Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
• Subject has a known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol).
• Subject has used photosensitizing drugs, e.g. declomycin, tetracycline, sulfa antibiotics, phenothiazines, etc. within a timeframe where photosensitization from these drugs may still be present.
• Subject has used OTC acne medicated cleansers or soaps within 2 weeks of the initiation of treatment.
• Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.

Sponsors & Collaborators

• DUSA Pharmaceuticals, Inc.: lead

Study Sites (14)

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Cherry Creek Research, Inc.

Denver, Colorado, 80209, United States

Location

Kenneth R. Beer, M.D. P.A.

West Palm Beach, Florida, 33401, United States

Location

Gwinnett Clinical Research Center, Inc.

Snellville, Georgia, 30078, United States

Location

Laser and Skin Surger Center of Indiana

Carmel, Indiana, 46032, United States

Location

Derm Research PLLC

Louisville, Kentucky, 40217, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Downstate Med Ctr

Brooklyn, New York, 11203, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Derm Research Inc

Austin, Texas, 78759, United States

Location

Baylor Research Institute

Dallas, Texas, 75246, United States

Location

Dermatology Research Center, Inc.

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Anna Houlihan
• Organization: Dusa Pharmaceuticals, Inc.

houlihana@dusapharma.com

Study Officials

• Stuart Marcus, M.D., PhD

  Sponsor GmbH

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 27, 2008
• Study Start: March 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: October 24, 2011
• Results First Posted: August 21, 2009

Record last verified: 2011-10

Locations

US (14)