Clinical trial NCT03024060: Phase 3 Study of Levulan With New Blue Light for AK on the Face or Scalp
Official title: A RANDOMIZED, VEHICLE-CONTROLLED PHASE 3 STUDY TO PROVE THE SAFETY AND EFFICACY OF LEVULAN KERASTICK (AMINOLEVULINIC ACID HCl) FOR TOPICAL SOLUTION, 20% AND 10 J/CM2 OF BLUE LIGHT DELIVERED AT 10 MW/CM2 OR 20 MW/CM2 BY A NEW LIGHT SOURCE FOR THE TREATMENT OF ACTINIC KERATOSES ON THE FACE OR SCALP
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Lead sponsor: DUSA Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Complete Clearance Rate
timeFrame: Week 12
Secondary outcomes:
measure: Baseline AK Clearance Rate
timeFrame: Baseline and Week 12
measure: Baseline AK Clearance Rate
timeFrame: Baseline and Week 8
measure: Complete Clearance Rate
timeFrame: Week 8
measure: Baseline AK Clearance Rate
timeFrame: Baseline and Week 4
measure: Complete Clearance Rate
timeFrame: Week 4
Other outcomes:
measure: Hyperpigmentation
timeFrame: Baseline
measure: Hyperpigmentation
timeFrame: 14-18 hours after Baseline - prior to light treatment
measure: Hyperpigmentation
timeFrame: 24 hours after PDT #1
measure: Hyperpigmentation
timeFrame: 2 Weeks after PDT #1
measure: Hyperpigmentation
timeFrame: 4 Weeks after PDT #1
measure: Hyperpigmentation
timeFrame: 8 Weeks after PDT #1
measure: Hyperpigmentation
timeFrame: 14-18 hours post Visit 6 (8 Weeks after PDT #1) prior to light treatment
measure: Hyperpigmentation
timeFrame: 12 Weeks after PDT #1
measure: Hypopigmentation
timeFrame: Baseline
measure: Hypopigmentation
timeFrame: 14-18 hours after Baseline - prior to light treatment
measure: Hypopigmentation
timeFrame: 24 hours after PDT #1
measure: Hypopigmentation
timeFrame: 2 Weeks after PDT #1
measure: Hypopigmentation
timeFrame: 4 Weeks after PDT #1
measure: Hypopigmentation
timeFrame: 8 Weeks after PDT #1
measure: Hypopigmentation
timeFrame: 14-18 hours post Visit 6 (8 Weeks after PDT #1) prior to light treatment
measure: Hypopigmentation
timeFrame: 12 Weeks after PDT #1
measure: Erythema
timeFrame: Baseline
measure: Erythema
timeFrame: 14-18 hours after Baseline - prior to light treatment
measure: Erythema
timeFrame: 5 minutes after PDT #1
measure: Erythema
timeFrame: 24 hours after PDT #1
measure: Erythema
timeFrame: 2 Weeks after PDT #1
measure: Erythema
timeFrame: 4 Weeks after PDT #1
measure: Erythema
timeFrame: 8 Weeks after PDT #1
measure: Erythema
timeFrame: 14-18 hours post Visit 6 (8 Weeks after PDT #1) prior to light treatment
measure: Erythema
timeFrame: 5 minutes after PDT #2
measure: Erythema
timeFrame: 12 Weeks after PDT #1
measure: Edema
timeFrame: Baseline
measure: Edema
timeFrame: 14-18 hours after Baseline - prior to light treatment
measure: Edema
timeFrame: 5 minutes after PDT #1
measure: Edema
timeFrame: 24 hours after PDT #1
measure: Edema
timeFrame: 2 weeks after PDT #1
measure: Edema
timeFrame: 4 Weeks after PDT #1
measure: Edema
timeFrame: 8 Weeks after PDT #1
measure: Edema
timeFrame: 14-18 hours after Visit 6 (8 Weeks after PDT #1) prior to light treatment
measure: Edema
timeFrame: 5 minutes after PDT #2
measure: Edema
timeFrame: 12 Weeks after PDT #1
measure: Stinging/Burning
timeFrame: Baseline
measure: Stinging/Burning
timeFrame: 14-18 hours after Baseline - prior to light treatment
measure: Stinging/Burning
timeFrame: During PDT #1
measure: Stinging/Burning
timeFrame: 5 minutes after PDT #1
measure: Stinging/Burning
timeFrame: 2 Weeks after PDT #1
measure: Stinging/Burning
timeFrame: 4 Weeks after PDT #1
measure: Stinging/Burning
timeFrame: 14-18 hours after Visit 6 (8 Weeks after PDT #1) prior to light treatment
measure: Stinging/Burning
timeFrame: during PDT #2
measure: Stinging/Burning
timeFrame: 5 minutes post PDT #2
measure: Stinging/Burning
timeFrame: 12 Weeks after PDT #1
measure: Scaling & Dryness
timeFrame: Baseline
measure: Scaling & Dryness
timeFrame: 14-18 hours after Baseline - prior to light treatment
measure: Scaling & Dryness
timeFrame: 24 hours after PDT #1
measure: Scaling & Dryness
timeFrame: 2 Weeks after PDT #1
measure: Scaling & Dryness
timeFrame: 4 Weeks after PDT #1
measure: Scaling & Dryness
timeFrame: 8 Weeks after PDT #1
measure: Scaling & Dryness
timeFrame: 14-18 hours after Visit 6 (8 Weeks after PDT #1) prior to light treatment
measure: Scaling & Dryness
timeFrame: 12 Weeks after PDT #1
measure: Oozing/Vesiculation/Crusting
timeFrame: Baseline
measure: Oozing/Vesiculation/Crusting
timeFrame: 14-18 hours after Baseline - prior to light treatment
measure: Oozing/Vesiculation/Crusting
timeFrame: 24 hours after PDT #1
measure: Oozing/Vesiculation/Crusting
timeFrame: 2 Weeks after PDT #1
measure: Oozing/Vesiculation/Crusting
timeFrame: 4 Weeks after PDT #1
measure: Oozing/Vesiculation/Crusting
timeFrame: 8 Weeks after PDT #1
measure: Oozing/Vesiculation/Crusting
timeFrame: 14-18 hours after Visit 6 (8 Weeks after PDT #1) prior to light treatment
measure: Oozing/Vesiculation/Crusting
timeFrame: 12 Weeks after PDT #1
Locations:
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Carmel
country: United States
facility: Shideler Clinical Research Center
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: DUSA Pharmaceuticals, Inc.
name: Stuart Marcus, MD, PhD
role: STUDY_DIRECTOR
References: