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

This study has been completed.
Sponsor:
Information provided by:
PhotoCure
ClinicalTrials.gov Identifier:
NCT00673933
First received: May 5, 2008
Last updated: January 14, 2010
Last verified: August 2008
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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
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
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PDT using MAL crem
 Drug: Methyl aminolevulinate (MAL) PDT
Cream application followed by illumination with red light
Placebo Comparator: 2
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:

  1. Female and male patients, age 15 to 40 years with acne vulgaris.
  2. Patients with skin type V or VI (Fitzpatrick).
  3. 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.
  4. Patients with no more than 2 nodular lesions in any of the two areas of each 8x8 cm2 on the back.
  5. 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.
  6. Patients must be willing and capable of following study instructions to the extent and degree required by the protocol.
  7. Patients must sign the approved informed consent form prior to any study procedures.
  8. Patients must be willing to be photographed. Patients must be willing to sign a photography consent form.

Exclusion Criteria:

  1. Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.
  2. Participation in other clinical studies either concurrently or within the last 30 days.
  3. 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.
  4. Clinically significant sensitivity to visible light, or has porphyria or porphyrin sensitivity.
  5. Exposure to ultraviolet radiation (UVB phototherapy) within the last 30 days.
  6. 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.
  7. Patients with a washout period for oral antibiotics for treatment of their acne of less than 1 month.
  8. 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

Locations
United States, Illinois
DuPage Medical Group
Naperville, Illinois, United States, 60563
Sponsors and Collaborators
PhotoCure
Investigators
Principal Investigator: Ashish C Bhatia, MD
  More Information

No publications provided

Responsible Party: Sylvia Vetrhus, Photocure
ClinicalTrials.gov Identifier: NCT00673933     History of Changes
Other Study ID Numbers: PC TA203/08
Study First Received: May 5, 2008
Last Updated: January 14, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Aminolevulinic Acid
Methyl 5-aminolevulinate
 Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013