Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Patients With Skin Type V or IV With Acne Vulgaris

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673933
• Other study ID #: PC TA203/08
• Status: Completed
• Phase: Phase 2
• First received: May 5, 2008
• Last updated: July 11, 2013
• Start date: May 2008
• Est. completion date: December 2008

Study information

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

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2008
• Est. primary completion date: December 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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), 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	DuPage Medical Group	Naperville	Illinois

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 Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment		4 weeks after last treatment, 6 weeks after baseline	Yes
Secondary	Erythema Score (Mild and Moderate)Immediately After First PDT	Patients with mild or moderate erythema after first treatment at baseline.	Immediately after treatment at baseline	Yes
Secondary	Change in Inflammatory Lesion Counts From Baseline		4 weeks after last treatment, 6 weeks after baseline	No
Secondary	Change in Noninflammatory Lesion Counts From Baseline		4 weeks after last treatment, 6 weeks after baseline	No
Secondary	Erythema Score (Mild and Moderate)Immediately After Second Treatment	Patients with mild or moderate erythema after second treatment.	Immediately after second treatment, 2 weeks after baseline	Yes
Secondary	Erythema Score (Mild and Moderate)1 Day After First Treatment	Patients with mild or moderate erythema 1 day after first treatment.	1 day after 1st treatment and baseline	Yes