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 (Responsible Party):
PhotoCure
ClinicalTrials.gov Identifier:
NCT00673933
First received: May 5, 2008
Last updated: July 11, 2013
Last verified: July 2013
  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:


Further study details as provided by PhotoCure:

Primary Outcome Measures:
  • Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment [ Time Frame: 4 weeks after last treatment, 6 weeks after baseline ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Erythema Score (Mild and Moderate)Immediately After First PDT [ Time Frame: Immediately after treatment at baseline ] [ Designated as safety issue: Yes ]
    Patients with mild or moderate erythema after first treatment at baseline.

  • Change in Inflammatory Lesion Counts From Baseline [ Time Frame: 4 weeks after last treatment, 6 weeks after baseline ] [ Designated as safety issue: No ]
  • Change in Noninflammatory Lesion Counts From Baseline [ Time Frame: 4 weeks after last treatment, 6 weeks after baseline ] [ Designated as safety issue: No ]
  • Erythema Score (Mild and Moderate)Immediately After Second Treatment [ Time Frame: Immediately after second treatment, 2 weeks after baseline ] [ Designated as safety issue: Yes ]
    Patients with mild or moderate erythema after second treatment.

  • Erythema Score (Mild and Moderate)1 Day After First Treatment [ Time Frame: 1 day after 1st treatment and baseline ] [ Designated as safety issue: Yes ]
    Patients with mild or moderate erythema 1 day after first treatment.


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

Detailed Description:

The treatment period started within 2 weeks of the study screen. Patients received two treatments (MAL PDT and vehicle PDT) to each of the treatment areas, 2 weeks apart, and were followed-up 4 weeks after last treatment. The total duration of the study was 6-8 weeks.

Methyl aminolevulinate 80 mg/g cream (MAL cream 8%)and vehicle was applied for 1.5 hours before illumination (Aktilite® CL128), total light dose 37 J/cm2

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Illinois
DuPage Medical Group
Naperville, Illinois, United States, 60563
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
PhotoCure
Investigators
Principal Investigator: Ashish C Bhatia, MD Dermatology Institute of DuPage Medical Group
  More Information

No publications provided

Responsible Party: PhotoCure
ClinicalTrials.gov Identifier: NCT00673933     History of Changes
Other Study ID Numbers: PC TA203/08
Study First Received: May 5, 2008
Results First Received: February 14, 2013
Last Updated: July 11, 2013
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
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 26, 2014