Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne - Full Text View

Sponsored by:	PhotoCure
Information provided by:	PhotoCure
ClinicalTrials.gov Identifier:	NCT00594425

Purpose

This multicenter study will be divided into 2 phases. The first phase will be an open label, dose-escalation phase, while the second will be a blinded, randomized, vehicle-controlled, parallel-group, dose-response phase. The second phase will only start if the first phase succeeds in establishing well tolerated dose(s). Patients with moderate to severe acne vulgaris in the face will be included.

Condition	Intervention	Phase
Acne Vulgaris	Drug: Methyl aminolevulinate (MAL) PDT	Phase II

MedlinePlus related topics: Acne

Drug Information available for: Aminolevulinic acid Aminolevulinic acid hydrochloride Methyl aminolevulinate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by PhotoCure:

Primary Outcome Measures:

The reduction in facial inflammatory (nodules, papules, and pustules) lesion counts from Baseline [ Time Frame: 3,6,12 and 24 weeks after last treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The reduction in nonfacial inflammatory lesion counts [ Time Frame: 3, 6, 12 and 24 weeks after last treatment ] [ Designated as safety issue: No ]
The reduction in total lesion counts for facial and nonfacial assessments [ Time Frame: 3,6,12 and 24 weeks after last treatment ] [ Designated as safety issue: No ]
The reduction in noninflammatory (whiteheads and blackheads) lesion counts for facial and nonfacial assessments [ Time Frame: 3,6,12 and 24 weeks after last treatment ] [ Designated as safety issue: No ]
Secondary endpoints include erythema score, hyperpigmentation score, hypopigmentation score, other local and nonlocal adverse events, and standard clinical chemistry parameters [ Time Frame: From baseline up to 24 weeks after the last treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	190
Study Start Date:	February 2007
Estimated Study Completion Date:	August 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental PDT using MAL concentration A	Drug: Methyl aminolevulinate (MAL) PDT Cream application followed by illumination with red light
2: Experimental PDT using MAL concentration B	Drug: Methyl aminolevulinate (MAL) PDT Cream application followed by illumination with red light
3: Placebo Comparator PDT using Placebo cream	Drug: Methyl aminolevulinate (MAL) PDT Cream application followed by illumination with red light

Eligibility

Ages Eligible for Study:	15 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female and male patients, age 15 to 40 years with moderate to severe facial acne vulgaris (IGA score 3-4).
Patients with skin type I to IV (Fitzpatrick).
Patients with 20 to 100 inflammatory lesions (papules, pustules, and nodules) on the face excluding lesions on the nose and in the peri-ocular area.
Patients with up to 200 noninflammatory lesions (open and closed comedones) on the face.
Patients with no more than 2 nodular lesions on the face.
Patients who are surgically sterile, 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 Day 0. 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.
Patients must be willing and capable of following study instructions to the extent and degree required by the protocol.
Patients must sign the approved informed consent form prior to any study procedures.
Patients must be willing to be photographed. Patients must be willing to sign a photography consent form.

Exclusion Criteria:

Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.
Participation in other clinical studies either concurrently or within the last 30 days.
Patients who have a condition or who are in a situation, which, in the investigator's opinion, may put the patient at risk, may confound the study results, or may interfere with the patient's participation in the study.
Clinically significant sensitivity to visible light, or has porphyria or porphyrin sensitivity.
Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within the last 30 days.
Patients with a washout period for topical treatments for their acne of less than 14 days. 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.
Patients with a washout period for oral isotretinoin of less than 6 months.
Patients with a beard or other facial hair that might interfere with study assessments.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594425

Locations

United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

PhotoCure

Investigators

Principal Investigator:

David Pariser, MD

AAD

More Information

Responsible Party:	Photocure ( Sylvia Vetrhus, Clinical Trial Manager )
Study ID Numbers:	PC TA202B/06
Study First Received:	January 3, 2008
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00594425
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Exanthema
Facial Dermatoses
Facies
Skin Diseases

Methyl 5-aminolevulinate
Sebaceous Gland Diseases
Acne Vulgaris
Aminolevulinic Acid

Additional relevant MeSH terms:

Photosensitizing Agents
Radiation-Sensitizing Agents
Acneiform Eruptions
Therapeutic Uses

Physiological Effects of Drugs
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009