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

NCT00673933 | Completed Phase 2 Results

• 1 other identifier: PC TA203/08
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

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

  4 weeks after last treatment, 6 weeks after baseline

Secondary Outcomes (5)

• Erythema Score (Mild and Moderate)Immediately After First PDT

  Immediately after treatment at baseline

• Change in Inflammatory Lesion Counts From Baseline

  4 weeks after last treatment, 6 weeks after baseline

• Change in Noninflammatory Lesion Counts From Baseline

  4 weeks after last treatment, 6 weeks after baseline

• Erythema Score (Mild and Moderate)Immediately After Second Treatment

  Immediately after second treatment, 2 weeks after baseline

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

  1 day after 1st treatment and baseline

Study Arms (2)

1

EXPERIMENTAL

PDT using MAL crem

Drug: Methyl aminolevulinate (MAL) PDT

2

PLACEBO COMPARATOR

PDT using Placebo cream

Drug: Methyl aminolevulinate (MAL) PDT

Interventions

Methyl aminolevulinate (MAL) PDT DRUG

Cream application followed by illumination with red light

1; 2

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Photocure: lead

Study Sites (2)

DuPage Medical Group

Naperville, Illinois, 60563, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

methyl 5-aminolevulinate; 1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Dr Ashish Bhatia
• Organization: Dermatology Institute

acbhatia@gmail.com

630-942-5040

Study Officials

• Ashish C Bhatia, MD

  Dermatology Institute of DuPage Medical Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 7, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 12, 2013
• Results First Posted: July 12, 2013

Record last verified: 2013-07

Locations

US (2)