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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: Methyl aminolevulinate (MAL) PDT	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	150 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Study Start Date :	February 2007
Actual Primary Completion Date :	July 2008
Actual Study Completion Date :	September 2008

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1; PDT using MAL concentration A	Drug: Methyl aminolevulinate (MAL) PDT; Cream application followed by illumination with red light
Experimental: 2; PDT using MAL concentration B	Drug: Methyl aminolevulinate (MAL) PDT; Cream application followed by illumination with red light
Placebo Comparator: 3; PDT using Placebo cream	Drug: Methyl aminolevulinate (MAL) PDT; Cream application followed by illumination with red light

Outcome Measures

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Primary Outcome Measures :

1. 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 ]
2. Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts [ Time Frame: 12 weeks after last treatment ]
3. Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline [ Time Frame: 3 weeks after last treatment ]
2. Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline [ Time Frame: 6 weeks after last treatment ]
3. Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline [ Time Frame: 6 weeks after last treatment ]
4. Percent Reduction in Total Lesion Counts From Baseline [ Time Frame: 6 weeks after last treatment ]
5. 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 ]
6. The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment [ Time Frame: 12 weeks after last treatment ]
7. 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
8. 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
9. 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
10. 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
11. Proportion of Patients With Mild and Moderate Erythema After First Treatment [ Time Frame: immediately after first treatment ]
12. Proportion of Patients With Mild and Moderate Erythema After First Treatment [ Time Frame: 2 days after first treatment ]
13. Proportion of Patients With Mild and Moderate Erythema After Second Treatment [ Time Frame: immediately after second treatment ]
14. Proportion of Patients With Mild and Moderate Erythema After Third Treatment [ Time Frame: immediately after third treatment ]
15. Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment [ Time Frame: immediately after fourth treatment ]
16. Proportion of Patients With Severe Erythema After First Treatment [ Time Frame: immediately after first treatment ]
17. Proportion of Patients With Severe Erythema 2 Days After First Treatment [ Time Frame: 2 days after first treatment ]
18. Proportion of Patients With Severe Erythema 7 Days After First Treatment [ Time Frame: 7 days after first treatment ]
19. Proportion of Patients With Severe Erythema After Second Treatment [ Time Frame: immediately after second treatment ]
20. Proportion of Patients With Severe Erythema After Third Treatment [ Time Frame: immediately after third treatment ]
21. Proportion of Patients With Severe Erythema After Fourth Treatment [ Time Frame: immediately after fourth treatment ]
22. Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment [ Time Frame: 2 days after treatment ]
23. Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment [ Time Frame: 2 weeks after first treatment ]
24. Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment [ Time Frame: 2 weeks after last treatment ]
25. Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment [ Time Frame: 6 weeks after last treatment ]
26. Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment [ Time Frame: 12 weeks after last treatment ]
27. Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment [ Time Frame: 2 days after first treatment ]
28. Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment [ Time Frame: 2 weeks after last treatment ]
29. Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment [ Time Frame: 2 weeks after first treatment ]
30. Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment [ Time Frame: 6 weeks after last treatment ]
31. Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment [ Time Frame: 12 weeks after last treatment ]

Eligibility Criteria

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Ages Eligible for Study:	15 Years to 40 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
Solano Clinical Research
Vallejo, California, United States, 94589
United States, Illinois
DuPage Medical Group
Naperville, Illinois, United States, 60563
United States, Michigan
Michigan Center for Research Corp
Clinton Twp, Michigan, United States, 48038
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, New York
Dermatology Associates of Rochester
Rochester, New York, United States, 14623
United States, Oklahoma
Central Sooner Research
Norman, Oklahoma, United States, 73069
United States, Oregon
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
United States, Texas
Dermatology Treatment & Research
Dallas, Texas, United States, 75230
Suzanne Bruce and Associates, PA
Houston, Texas, United States, 77056
The Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States, 84124
United States, Virginia
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States, 24501-1604
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Photocure

Investigators

Principal Investigator:	David Pariser, MD	AAD

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Photocure
ClinicalTrials.gov Identifier:	NCT00594425 History of Changes
Other Study ID Numbers:	PC TA202B/06
First Posted:	January 15, 2008
Results First Posted:	August 8, 2013
Last Update Posted:	August 8, 2013
Last Verified:	August 2013

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases	Aminolevulinic Acid; Methyl 5-aminolevulinate; Photosensitizing Agents; Dermatologic Agents