Phase 3 Study of Levulan With New Blue Light for AK on the Face or Scalp

Dusa Pharmaceuticals

Status and phase: Withdrawn; Phase 3

Conditions: Actinic Keratosis

Treatments: Device: IBL 10 mW; Device: IBL 20 mW; Drug: ALA; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT03024060

CP0114

Details and patient eligibility

About

The purpose of this study is to prove the safety and efficacy of Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the face or balding scalp (the Treatment Area), utilizing a 14-18 hour incubation period.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on the face OR balding scalp

Exclusion criteria

• Pregnancy

• grade 3 and/or atypical >1cm AKs within Treatment Area and/or more than 15 AKs of any Grade within the Treatment Area

• 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

• unsuccessful outcome from previous ALA-PDT therapy

• 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 active herpes simplex infection in the Treatment Area OR a history of 2 or more outbreaks within past 12 months, in the Treatment Area

• 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 of initiation of treatment.
  • Curettage or Cryotherapy within 2 weeks of initiation of treatment
  • Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks of initiation of treatment.
  • Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.

• use of systemic retinoid therapy within 6 months of initiation of treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups, including a placebo group

ALA 20 mW

Experimental group

Description:

ALA + IBL 10J at 20 mW (8min 20 sec)

Treatment:

Drug: ALA

Device: IBL 20 mW

ALA 10 mW

Experimental group

Description:

ALA + IBL 10J at 10 mW (16 min 40 sec)

Treatment:

Drug: ALA

Device: IBL 10 mW

Vehicle

Placebo Comparator group

Description:

Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving light treatment delivered at 20 mW/cm2 OR 10 mW/cm2. Subjects receiving VEH will be considered a single treatment group

Treatment:

Drug: Vehicle

Device: IBL 20 mW

Device: IBL 10 mW