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Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne

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ClinicalTrials.gov Identifier: NCT00594425
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : August 8, 2013
Last Update Posted : August 8, 2013
Sponsor:
Information provided by (Responsible Party):
Photocure

Tracking Information
First Submitted Date  ICMJE January 3, 2008
First Posted Date  ICMJE January 15, 2008
Results First Submitted Date  ICMJE March 14, 2013
Results First Posted Date  ICMJE August 8, 2013
Last Update Posted Date August 8, 2013
Study Start Date  ICMJE February 2007
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2013)
  • Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment [ Time Frame: 12 weeks after last treatment ]
  • Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts [ Time Frame: 12 weeks after last treatment ]
  • Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2008)
The reduction in facial inflammatory (nodules, papules, and pustules) lesion counts from Baseline [ Time Frame: 3,6,12 and 24 weeks after last treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2013)
  • Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline [ Time Frame: 3 weeks after last treatment ]
  • Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline [ Time Frame: 6 weeks after last treatment ]
  • Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline [ Time Frame: 6 weeks after last treatment ]
  • Percent Reduction in Total Lesion Counts From Baseline [ Time Frame: 6 weeks after last treatment ]
  • Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment [ Time Frame: 6 weeks after last treatment ]
  • The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment [ Time Frame: 12 weeks after last treatment ]
  • Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain. [ Time Frame: immediately after illumination-first treatment ]
    Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
  • Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain [ Time Frame: immediately after second treatment ]
    Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
  • Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain. [ Time Frame: immediately after third treatment ]
    Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
  • Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain. [ Time Frame: immediately after illumination-fourth treatment treatment ]
    Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
  • Proportion of Patients With Mild and Moderate Erythema After First Treatment [ Time Frame: immediately after first treatment ]
  • Proportion of Patients With Mild and Moderate Erythema After First Treatment [ Time Frame: 2 days after first treatment ]
  • Proportion of Patients With Mild and Moderate Erythema After Second Treatment [ Time Frame: immediately after second treatment ]
  • Proportion of Patients With Mild and Moderate Erythema After Third Treatment [ Time Frame: immediately after third treatment ]
  • Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment [ Time Frame: immediately after fourth treatment ]
  • Proportion of Patients With Severe Erythema After First Treatment [ Time Frame: immediately after first treatment ]
  • Proportion of Patients With Severe Erythema 2 Days After First Treatment [ Time Frame: 2 days after first treatment ]
  • Proportion of Patients With Severe Erythema 7 Days After First Treatment [ Time Frame: 7 days after first treatment ]
  • Proportion of Patients With Severe Erythema After Second Treatment [ Time Frame: immediately after second treatment ]
  • Proportion of Patients With Severe Erythema After Third Treatment [ Time Frame: immediately after third treatment ]
  • Proportion of Patients With Severe Erythema After Fourth Treatment [ Time Frame: immediately after fourth treatment ]
  • Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment [ Time Frame: 2 days after treatment ]
  • Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment [ Time Frame: 2 weeks after first treatment ]
  • Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment [ Time Frame: 2 weeks after last treatment ]
  • Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment [ Time Frame: 6 weeks after last treatment ]
  • Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment [ Time Frame: 12 weeks after last treatment ]
  • Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment [ Time Frame: 2 days after first treatment ]
  • Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment [ Time Frame: 2 weeks after last treatment ]
  • Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment [ Time Frame: 2 weeks after first treatment ]
  • Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment [ Time Frame: 6 weeks after last treatment ]
  • Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment [ Time Frame: 12 weeks after last treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2008)
  • The reduction in nonfacial inflammatory lesion counts [ Time Frame: 3, 6, 12 and 24 weeks after last treatment ]
  • The reduction in total lesion counts for facial and nonfacial assessments [ Time Frame: 3,6,12 and 24 weeks after last treatment ]
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne
Official Title  ICMJE Not Provided
Brief Summary 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.The results from part 2 has been presented in the result section.
Detailed Description For the second part: All patients will receive 4 PDT sessions 2 weeks apart using a light dose of 37 J/cm2. One treatment group will receive vehicle cream, while the other 2 groups will receive MAL cream with a concentration of 40 mg/g and 80 mg/g, respectively. The MAL and vehicle cream will be applied in a thin layer on clean skin and left for 1.5 hours under occlusion before illumination.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE Drug: Methyl aminolevulinate (MAL) PDT
Cream application followed by illumination with red light
Study Arms  ICMJE
  • Experimental: 1
    PDT using MAL concentration A
    Intervention: Drug: Methyl aminolevulinate (MAL) PDT
  • Experimental: 2
    PDT using MAL concentration B
    Intervention: Drug: Methyl aminolevulinate (MAL) PDT
  • Placebo Comparator: 3
    PDT using Placebo cream
    Intervention: Drug: Methyl aminolevulinate (MAL) PDT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2013)
150
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2008)
190
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female and male patients, age 15 to 40 years with moderate to severe facial acne vulgaris (IGA score 3-4).
  2. Patients with skin type I to IV (Fitzpatrick).
  3. 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.
  4. Patients with up to 200 noninflammatory lesions (open and closed comedones) on the face.
  5. Patients with no more than 2 nodular lesions on the face.
  6. 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.
  7. Patients must be willing and capable of following study instructions to the extent and degree required by the protocol.
  8. Patients must sign the approved informed consent form prior to any study procedures.
  9. 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, sun tanning salons) within the last 30 days.
  6. 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.
  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.
  9. Patients with a beard or other facial hair that might interfere with study assessments.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00594425
Other Study ID Numbers  ICMJE PC TA202B/06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Photocure
Study Sponsor  ICMJE Photocure
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Pariser, MD AAD
PRS Account Photocure
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP