Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face

Dusa Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Actinic Keratosis

Treatments: Drug: Topical Solution Vehicle; Device: IBL 20 mW; Device: IBL 10 mW; Drug: ALA; Procedure: Microneedle lesion preparation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02632110

CP0112

Details and patient eligibility

About

The purpose of this study is to determine the viability of microneedle lesion preparation (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis (AK) field on the face.

Enrollment: 137 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Four to eight AKs on the face

Exclusion criteria

• Pregnancy

• history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis

• lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area

• skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy

• Subject is immunosuppressed

• currently enrolled in an investigational drug or device study

• has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment

• known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)

• has an active herpes simplex infection OR a history of 2 or more outbreaks within the past 12 months, on the face

• use of the following topical preparations on the extremity to be treated:

  • Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days
  • Curettage or Cryotherapy within 2 weeks of initiation of treatment
  • Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks
  • Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5 fluorouracil, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks

• use of systemic retinoid therapy within 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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137 participants in 10 patient groups, including a placebo group

ALA 25 min 10 Milliwatts (mW)

Experimental group

Description:

ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.

Treatment:

Drug: ALA

Device: IBL 10 mW

MN + ALA 25 min 10 mW

Experimental group

Description:

Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.

Treatment:

Drug: ALA

Device: IBL 10 mW

Procedure: Microneedle lesion preparation

ALA 25 min 20 mW

Experimental group

Description:

ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.

Treatment:

Drug: ALA

Device: IBL 20 mW

MN + ALA 25 min 20 mW

Experimental group

Description:

Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.

Treatment:

Drug: ALA

Procedure: Microneedle lesion preparation

Device: IBL 20 mW

ALA 60 min 10 mW

Experimental group

Description:

ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.

Treatment:

Drug: ALA

Device: IBL 10 mW

MN + ALA 60 min 10 mW

Experimental group

Description:

Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.

Treatment:

Drug: ALA

Device: IBL 10 mW

Procedure: Microneedle lesion preparation

ALA 60 min 20 mW

Experimental group

Description:

ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.

Treatment:

Drug: ALA

Device: IBL 20 mW

MN + ALA 60 min 20 mW

Experimental group

Description:

Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment.

Treatment:

Drug: ALA

Procedure: Microneedle lesion preparation

Device: IBL 20 mW

VEH

Placebo Comparator group

Description:

Vehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.

Treatment:

Device: IBL 10 mW

Drug: Topical Solution Vehicle

MN + VEH

Placebo Comparator group

Description:

Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.

Treatment:

Device: IBL 10 mW

Drug: Topical Solution Vehicle

Procedure: Microneedle lesion preparation