Short Incubation Methylaminolevulinate Photodynamic Therapy Without Occlusion

NCT00926952 | Completed Phase 3 Results

• 1 other identifier: Inno-6010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Actinic keratoses on the face are often numerous and widespread. The application of Methylaminolevulinate (MAL) on individual lesions followed by the application of a plastic film on each lesion is difficult and takes time for subjects with many actinic keratoses. The waiting period of 3 hours between MAL cream application and red light exposure is also long for patients. The goal of this study is to evaluate the safety and efficacy of photodynamic therapy (PDT) with MAL with a shorter cream application time (90 minutes) and when MAL is applied on the entire face without the plastic film.

Conditions

Actinic Keratosis

Keywords

Actinic keratoses; actinic keratosis; methylamonolevulinate; photodynamic therapy; without occlusion; short incubation

Outcome Measures

Primary Outcomes (1)

• Mean Number of Facial Actinic Keratoses at Week 12

  12 weeks

Secondary Outcomes (8)

• Number of Patients With Complete Clinical Response of All Actinic Keratoses at Week 12

  12 weeks

• Number of Actinic Keratosis Lesions With Complete Clinical Response at Day 0 and Week 12

  0, 12 weeks

• Mean Griffiths Photonumeric Scale for Photodamage Score at Week 12

  12 weeks

• Mean Fine Wrinkling Score at Week 12

  12 weeks

• Mean Coarse Wrinkling Score at Week 12

  12 weeks

Study Arms (1)

MAL-PDT 90 min incubation, no occlusion

EXPERIMENTAL

Patients had 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and waited 90 minutes prior to photodynamic therapy (PDT) using red light.

Drug: Methylaminolevulinate (Metvix, Metvixia); Device: Photodynamic Therapy (Aktilite)

Interventions

Methylaminolevulinate (Metvix, Metvixia) DRUG

2-4 g of cream applied to entire face at Day 0 for 90 minutes without occlusion prior to light treatment. If any actinic keratoses remained after 4 weeks the treatment was repeated at Week 4.

Also known as: Metvix, Metvixia

MAL-PDT 90 min incubation, no occlusion

Photodynamic Therapy (Aktilite) DEVICE

Device set to 37 J/cm². Red light wavelength is approximately 630 nm.

Also known as: Aktilite

MAL-PDT 90 min incubation, no occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older.
• Patient with at least 5 actinic keratoses of the face at Day 0.
• Patient was willing to use an adequate contraceptive method or was surgically sterile, post menopausal, abstinent or with a same sex partner. Adequate means of contraception included oral contraceptives, IUD in use for 30 days before Day 0, barrier methods and spermicide in use at least 14 days before Day 0.
• Patient capable of giving informed consent.

You may not qualify if:

• Patient with allergy to methylaminolevulinate or any component of the vehicle which includes peanut and almond oil.
• Patient with clinically significant sensitivity to visible light, porphyria or porphyrin sensitivity.
• Patient used any topical treatment for actinic keratoses (including imiquimod and 5-fluouracil), on the face within 4 weeks preceding Day 0.
• Patient had cryotherapy or surgery on the face within 4 weeks preceding Day 0.
• Patient with any malignant skin lesion (such as basal cell carcinoma, invasive squamous cell carcinoma or Bowen's disease) on the face at Day 0.
• Patient used photodynamic therapy, with any topical or systemic photosensitizer within 8 weeks preceding Day 0.
• Patient was exposed to excessive ultraviolet radiation (UVB phototherapy, sun tanning salons) within the 4 weeks preceding Day 0.
• Patient used any investigational drug within 4 weeks preceding Day 0.
• Patient with problems of alcoholism or drug abuse in the past year.
• Patient with any unstable or serious uncontrolled medical condition.
• Current pregnancy or lactation.
• Patient with any serious dermatological disorder, including malignancies that would either put the patient at risk or interfere with efficacy or safety evaluations.
• Patient with Fitzpatrick phototype IV, V or VI (inadequate penetration of red light in dark skinned subjects.
• Patients with extensive facial hair (e.g., beard) that would either impair red light exposure or interfere with lesion evaluation.

Sponsors & Collaborators

• Innovaderm Research Inc.: lead
• Galderma Canada: collaborator

Study Sites (1)

Innovaderm Research Inc

Montreal, Quebec, H2K 4L5, Canada

Location

Related Publications (1)

• Griffiths CE, Wang TS, Hamilton TA, Voorhees JJ, Ellis CN. A photonumeric scale for the assessment of cutaneous photodamage. Arch Dermatol. 1992 Mar;128(3):347-51.

  PMID: 1550366 BACKGROUND

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

methyl 5-aminolevulinate; Photochemotherapy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Results Point of Contact

• Title: Annie Levesque
• Organization: Innovaderm Research Inc.

alevesque@innovaderm.ca

514-521-4285

Study Officials

• Robert Bissonnette, MD, FRCPC

  Innovaderm Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2009
• First Posted: June 24, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: September 9, 2011
• Results First Posted: February 17, 2011

Record last verified: 2011-09

Locations

CA (1)