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

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Methyl aminolevulinate (MAL) PDT

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:

Female and male patients, age 15 to 40 years with acne vulgaris.
Patients with skin type V or VI (Fitzpatrick).
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.
Patients with no more than 2 nodular lesions in any of the two areas of each 8x8 cm2 on the back.
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.
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) within the last 30 days.
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.
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.

Sites / Locations

DuPage Medical Group
Academic Dermatology Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

PDT using MAL crem

PDT using Placebo cream

Outcomes

Primary Outcome Measures

Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment

Secondary Outcome Measures

Erythema Score (Mild and Moderate)Immediately After First PDT

Patients with mild or moderate erythema after first treatment at baseline.

Change in Inflammatory Lesion Counts From Baseline

Change in Noninflammatory Lesion Counts From Baseline

Erythema Score (Mild and Moderate)Immediately After Second Treatment

Patients with mild or moderate erythema after second treatment.

Erythema Score (Mild and Moderate)1 Day After First Treatment

Patients with mild or moderate erythema 1 day after first treatment.

Full Information

NCT ID

NCT00673933

First Posted

May 5, 2008

Last Updated

July 11, 2013

Sponsor

Photocure

1. Study Identification

Unique Protocol Identification Number

NCT00673933

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Photocure

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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

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

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

PDT using MAL crem

Arm Title

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 Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment

Time Frame

4 weeks after last treatment, 6 weeks after baseline

Secondary Outcome Measure Information:

Title

Erythema Score (Mild and Moderate)Immediately After First PDT

Description

Patients with mild or moderate erythema after first treatment at baseline.

Time Frame

Immediately after treatment at baseline

Title

Change in Inflammatory Lesion Counts From Baseline

Time Frame

4 weeks after last treatment, 6 weeks after baseline

Title

Change in Noninflammatory Lesion Counts From Baseline

Time Frame

4 weeks after last treatment, 6 weeks after baseline

Title

Erythema Score (Mild and Moderate)Immediately After Second Treatment

Description

Patients with mild or moderate erythema after second treatment.

Time Frame

Immediately after second treatment, 2 weeks after baseline

Title

Erythema Score (Mild and Moderate)1 Day After First Treatment

Description

Patients with mild or moderate erythema 1 day after first treatment.

Time Frame

1 day after 1st treatment and baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female and male patients, age 15 to 40 years with acne vulgaris. Patients with skin type V or VI (Fitzpatrick). 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. Patients with no more than 2 nodular lesions in any of the two areas of each 8x8 cm2 on the back. 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. 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) within the last 30 days. 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ashish C Bhatia, MD

Organizational Affiliation

Dermatology Institute of DuPage Medical Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

DuPage Medical Group

City

Naperville

State/Province

Illinois

ZIP/Postal Code

60563

Country

United States

Facility Name

Academic Dermatology Associates

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

12. IPD Sharing Statement

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

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