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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Methyl aminolevulinate (MAL) PDT
Sponsored by
Photocure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Therapeutics Clinical Research
  • Solano Clinical Research
  • DuPage Medical Group
  • Michigan Center for Research Corp
  • Academic Dermatology Associates
  • Dermatology Associates of Rochester
  • Central Sooner Research
  • Oregon Dermatology and Research Center
  • Dermatology Treatment & Research
  • Suzanne Bruce and Associates, PA
  • The Dermatology Clinical Research Center of San Antonio
  • Dermatology Research Center, Inc.
  • The Education & Research Foundation, Inc.
  • Virginia Clinical Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

PDT using MAL concentration A

PDT using MAL concentration B

PDT using Placebo cream

Outcomes

Primary Outcome Measures

Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline

Secondary Outcome Measures

Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline
Percent Reduction in Total Lesion Counts From Baseline
Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment
The Proportion of Patients Rated as Clear or Almost Clear at 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.
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
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.
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.
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Proportion of Patients With Mild and Moderate Erythema After First Treatment
Proportion of Patients With Mild and Moderate Erythema After First Treatment
Proportion of Patients With Mild and Moderate Erythema After Second Treatment
Proportion of Patients With Mild and Moderate Erythema After Third Treatment
Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment
Proportion of Patients With Severe Erythema After First Treatment
Proportion of Patients With Severe Erythema 2 Days After First Treatment
Proportion of Patients With Severe Erythema 7 Days After First Treatment
Proportion of Patients With Severe Erythema After Second Treatment
Proportion of Patients With Severe Erythema After Third Treatment
Proportion of Patients With Severe Erythema After Fourth Treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment

Full Information

First Posted
January 3, 2008
Last Updated
August 7, 2013
Sponsor
Photocure
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1. Study Identification

Unique Protocol Identification Number
NCT00594425
Brief Title
Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Moderate to Severe Acne
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Photocure

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
PDT using MAL concentration A
Arm Title
2
Arm Type
Experimental
Arm Description
PDT using MAL concentration B
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
PDT using Placebo cream
Intervention Type
Drug
Intervention Name(s)
Methyl aminolevulinate (MAL) PDT
Intervention Description
Cream application followed by illumination with red light
Primary Outcome Measure Information:
Title
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
Title
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts
Time Frame
12 weeks after last treatment
Title
Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Time Frame
3 weeks after last treatment
Title
Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
Time Frame
6 weeks after last treatment
Title
Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline
Time Frame
6 weeks after last treatment
Title
Percent Reduction in Total Lesion Counts From Baseline
Time Frame
6 weeks after last treatment
Title
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
Title
The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment
Time Frame
12 weeks after last treatment
Title
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
Description
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Time Frame
immediately after illumination-first treatment
Title
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain
Description
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Time Frame
immediately after second treatment
Title
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
Description
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Time Frame
immediately after third treatment
Title
Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
Description
Measure was assessed on a Visual Analogue Scale from 0 to 10 cm
Time Frame
immediately after illumination-fourth treatment treatment
Title
Proportion of Patients With Mild and Moderate Erythema After First Treatment
Time Frame
immediately after first treatment
Title
Proportion of Patients With Mild and Moderate Erythema After First Treatment
Time Frame
2 days after first treatment
Title
Proportion of Patients With Mild and Moderate Erythema After Second Treatment
Time Frame
immediately after second treatment
Title
Proportion of Patients With Mild and Moderate Erythema After Third Treatment
Time Frame
immediately after third treatment
Title
Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment
Time Frame
immediately after fourth treatment
Title
Proportion of Patients With Severe Erythema After First Treatment
Time Frame
immediately after first treatment
Title
Proportion of Patients With Severe Erythema 2 Days After First Treatment
Time Frame
2 days after first treatment
Title
Proportion of Patients With Severe Erythema 7 Days After First Treatment
Time Frame
7 days after first treatment
Title
Proportion of Patients With Severe Erythema After Second Treatment
Time Frame
immediately after second treatment
Title
Proportion of Patients With Severe Erythema After Third Treatment
Time Frame
immediately after third treatment
Title
Proportion of Patients With Severe Erythema After Fourth Treatment
Time Frame
immediately after fourth treatment
Title
Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
Time Frame
2 days after treatment
Title
Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
Time Frame
2 weeks after first treatment
Title
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Time Frame
2 weeks after last treatment
Title
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Time Frame
6 weeks after last treatment
Title
Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
Time Frame
12 weeks after last treatment
Title
Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
Time Frame
2 days after first treatment
Title
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Time Frame
2 weeks after last treatment
Title
Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
Time Frame
2 weeks after first treatment
Title
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Time Frame
6 weeks after last treatment
Title
Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
Time Frame
12 weeks after last treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Pariser, MD
Organizational Affiliation
AAD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Solano Clinical Research
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
DuPage Medical Group
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Michigan Center for Research Corp
City
Clinton Twp
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Dermatology Associates of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Dermatology Treatment & Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Suzanne Bruce and Associates, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
The Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dermatology Research Center, Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
The Education & Research Foundation, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501-1604
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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