Clinical trial NCT00926952: Short Incubation Methylaminolevulinate Photodynamic Therapy Without Occlusion
Official title: Safety and Efficacy of Photodynamic Therapy With Short Incubation Methylaminolevulinate Without Occlusion in the Treatment of Actinic Keratoses.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Keywords: Actinic keratoses
actinic keratosis
methylamonolevulinate
photodynamic therapy
without occlusion
short incubation
Lead sponsor: Innovaderm Research Inc.
Sponsor class: OTHER
Collaborators: name: Galderma Canada
First posted: 2009-06-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: A total of 20 patients with at least 5 non-hypertrophic actinic keratoses (AK) of the face were included in this open-label study. All AKs were mapped on a transparent template before the first PDT treatment. At Day 0, all patients received methylaminolevulinate (MAL) applied on the entire face (except the nose and peri-ocular area of 1-2 cm) without any skin preparation. One to two 2 g MAL tubes was used for the entire face. MAL was applied without occlusion. After a total of 90 +/- 5 minutes the skin was rinsed and exposed to 37 J/cm² of red light from an Aktilite™ device. Patients were seen at Week 4; if all facial AKs did not show a complete response to treatment, the MAL-PDT procedure was repeated at Week 4. Patients were seen again at Week 12 and 24.

The primary endpoint was at Week 12. Patients came back at Week 24 for a final safety evaluation and to verify the recurrence of AK.

Efficacy is evaluated by assessing the mean number of facial AK at Week 12 as compared to Day 0.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mean Number of Facial Actinic Keratoses at Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Patients With Complete Clinical Response of All Actinic Keratoses at Week 12
timeFrame: 12 weeks
measure: Number of Actinic Keratosis Lesions With Complete Clinical Response at Day 0 and Week 12
timeFrame: 0, 12 weeks
measure: Mean Griffiths Photonumeric Scale for Photodamage Score at Week 12
timeFrame: 12 weeks
measure: Mean Fine Wrinkling Score at Week 12
timeFrame: 12 weeks
measure: Mean Coarse Wrinkling Score at Week 12
timeFrame: 12 weeks
measure: Mean Sallowness Score at Week 12
timeFrame: 12 weeks
measure: Mean Mottled Hyperpigmentation at Week 12
timeFrame: 12 weeks
measure: Number of Adverse Events
timeFrame: 12, 24 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Innovaderm Research Inc
state: Quebec
Study officials:
affiliation: Innovaderm Research
name: Robert Bissonnette, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.