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Safety and Efficacy of Photodynamic Therapy With Short Incubation Methylaminolevulinate Without Occlusion in the Treatment of Actinic Keratoses.


Phase 3
18 Years
N/A
Not Enrolling
Both
Actinic Keratosis

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Trial Information

Safety and Efficacy of Photodynamic Therapy With Short Incubation Methylaminolevulinate Without Occlusion in the Treatment of Actinic Keratoses.


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Mean Number of Facial Actinic Keratoses at Week 12

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Robert Bissonnette, MD, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Innovaderm Research

Authority:

Canada: Health Canada

Study ID:

Inno-6010

NCT ID:

NCT00926952

Start Date:

July 2009

Completion Date:

January 2011

Related Keywords:

  • Actinic Keratosis
  • Actinic keratoses
  • actinic keratosis
  • methylamonolevulinate
  • photodynamic therapy
  • without occlusion
  • short incubation
  • Keratosis
  • Keratosis, Actinic

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