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

Acne Vulgaris Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594425
• Other study ID #: PC TA202B/06
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2008
• Last updated: August 7, 2013
• Start date: February 2007
• Est. completion date: September 2008

Study information

• Verified date: August 2013
• Source: Photocure
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Methyl aminolevulinate (MAL) PDT
Cream application followed by illumination with red light

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Michigan Center for Research Corp	Clinton Twp	Michigan
United States	Dermatology Treatment & Research	Dallas	Texas
United States	Suzanne Bruce and Associates, PA	Houston	Texas
United States	The Education & Research Foundation, Inc.	Lynchburg	Virginia
United States	DuPage Medical Group	Naperville	Illinois
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Central Sooner Research	Norman	Oklahoma
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Dermatology Associates of Rochester	Rochester	New York
United States	Dermatology Research Center, Inc.	Salt Lake City	Utah
United States	The Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	Therapeutics Clinical Research	San Diego	California
United States	Solano Clinical Research	Vallejo	California

Sponsors (1)

Lead Sponsor	Collaborator
Photocure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment		12 weeks after last treatment	No
Primary	Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts		12 weeks after last treatment	No
Primary	Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline		12 weeks	No
Secondary	Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline		3 weeks after last treatment	No
Secondary	Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline		6 weeks after last treatment	No
Secondary	Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline		6 weeks after last treatment	No
Secondary	Percent Reduction in Total Lesion Counts From Baseline		6 weeks after last treatment	No
Secondary	Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment		6 weeks after last treatment	No
Secondary	The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment		12 weeks after last treatment	No
Secondary	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	immediately after illumination-first treatment	Yes
Secondary	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	immediately after second treatment	Yes
Secondary	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	immediately after third treatment	Yes
Secondary	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	immediately after illumination-fourth treatment treatment	Yes
Secondary	Proportion of Patients With Mild and Moderate Erythema After First Treatment		immediately after first treatment	Yes
Secondary	Proportion of Patients With Mild and Moderate Erythema After First Treatment		2 days after first treatment	Yes
Secondary	Proportion of Patients With Mild and Moderate Erythema After Second Treatment		immediately after second treatment	Yes
Secondary	Proportion of Patients With Mild and Moderate Erythema After Third Treatment		immediately after third treatment	Yes
Secondary	Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment		immediately after fourth treatment	Yes
Secondary	Proportion of Patients With Severe Erythema After First Treatment		immediately after first treatment	Yes
Secondary	Proportion of Patients With Severe Erythema 2 Days After First Treatment		2 days after first treatment	Yes
Secondary	Proportion of Patients With Severe Erythema 7 Days After First Treatment		7 days after first treatment	Yes
Secondary	Proportion of Patients With Severe Erythema After Second Treatment		immediately after second treatment	Yes
Secondary	Proportion of Patients With Severe Erythema After Third Treatment		immediately after third treatment	Yes
Secondary	Proportion of Patients With Severe Erythema After Fourth Treatment		immediately after fourth treatment	Yes
Secondary	Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment		2 days after treatment	Yes
Secondary	Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment		2 weeks after first treatment	Yes
Secondary	Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment		2 weeks after last treatment	Yes
Secondary	Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment		6 weeks after last treatment	Yes
Secondary	Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment		12 weeks after last treatment	Yes
Secondary	Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment		2 days after first treatment	Yes
Secondary	Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment		2 weeks after last treatment	Yes
Secondary	Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment		2 weeks after first treatment	Yes
Secondary	Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment		6 weeks after last treatment	Yes
Secondary	Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment		12 weeks after last treatment	Yes