Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Patients With Skin Type V or IV With Acne Vulgaris - Full Text View

Sponsor:	PhotoCure
Information provided by:	PhotoCure
ClinicalTrials.gov Identifier:	NCT00673933

Purpose

In this multicenter study, patients with dark skin and acne vulgaris will be included. The patients will receive treatment with MAL PDT and placebo PDT.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Blinded, Randomized, Intra-Individual, Vehicle-Controlled and Multi-Centre Study of Photodynamic Therapy With MAL Cream in Patients With Skin Type V or VI With Acne Vulgaris

Resource links provided by NLM:

MedlinePlus related topics: Acne

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

U.S. FDA Resources

Further study details as provided by PhotoCure:

Primary Outcome Measures:

Hypopigmentation and hyperpigmentation score assessed after treatment [ Time Frame: 4 weeks after last treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Erythema score and other local and non-local adverse events [ Time Frame: After treatment ] [ Designated as safety issue: Yes ]
The reduction in inflammatory lesion counts from baseline [ Time Frame: 4 weeks after last treatment ] [ Designated as safety issue: No ]
The reduction in noninflammatory lesion counts from baseline [ Time Frame: 4 weeks after last treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental PDT using MAL crem	Drug: Methyl aminolevulinate (MAL) PDT Cream application followed by illumination with red light
2: 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 acne vulgaris.
Patients with skin type V or VI (Fitzpatrick).
Patients with two areas of each 8x8 cm2 on the back that include at least 5 inflammatory lesions (papules, pustules, and nodules) each. The minimum distance between the two areas should be at least 4 cm.
Patients with no more than 2 nodular lesions in any of the two areas of each 8x8 cm2 on the back.
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 3 months and must agree to stay with the same product and dose for an additional 3 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) within the last 30 days.
Patients with a washout period for topical treatments for their acne in the two treatment areas of less than 14 days. Any topical treatment on the face or other areas outside the two treatment areas will be allowed.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673933

Contacts

Contact: Sylvia Vetrhus, MSc.Pharm	+47 22061646	sv@photocure.no
Contact: Per Fuglerud, Msc	+47 22061654	pf@photocure.no

Locations

United States, Illinois
DuPage Medical Group	Recruiting
Naperville, Illinois, United States, 60563
Principal Investigator: Ashish C Bhatia, MD

Sponsors and Collaborators

PhotoCure

Investigators

Principal Investigator:

Ashish C Bhatia, MD

More Information

No publications provided

Responsible Party:	Photocure ( Sylvia Vetrhus )
Study ID Numbers:	PC TA203/08
Study First Received:	May 5, 2008
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00673933 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Facial Dermatoses
Skin Diseases
Physiological Effects of Drugs
Methyl 5-aminolevulinate
Sebaceous Gland Diseases
Acne Vulgaris
Pharmacologic Actions

Aminolevulinic Acid
Photosensitizing Agents
Radiation-Sensitizing Agents
Acneiform Eruptions
Therapeutic Uses
Dermatologic Agents

ClinicalTrials.gov processed this record on November 27, 2009