Clinical trial NCT02628236: Maximal Use Systemic Exposure Study of Levulan Kerastick (MUSE 2)
Official title: A Pharmacokinetic Study of Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% Under Maximal Use Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Keratosis, Actinic
Keywords: Actinic keratosis
Lead sponsor: DUSA Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the potential for systemic exposure of aminolevulinic acid (ALA) and protoporphyrin IX (PpIX) when applied topically under occlusion, in a maximal use setting in patients with multiple actinic keratoses (AK) involving the upper extremities.


Eligibility criteria: Inclusion Criteria:

* At least 6 Grade 1/2 AKs on one upper extremity AND
* At least 12 Grade 1/2 AKs on the OTHER upper extremity

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
* Body Mass Index (BMI) \> 32.0 kg/m2
* skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
* significant blood loss within 60 days or donated blood/plasma within 72 hours prior to Visit 2 (Baseline)
* tested positive at screening for human immunodeficiency virus (HIV) or was known to be seropositive for HIV
* a history of lead poisoning or a history of a significant exposure to lead
* tested positive at screening for hepatitis B surface antigen, hepatitis C antibody or had a history of a positive result
* positive drug screen at Screening
* Screening safety labs are clinically significant in the opinion of the investigator
* major surgery within 30 days prior to Visit 2 (Baseline) or plans to have surgery during the study
* 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 Visit 2 (Baseline)
* known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
* use of the following topical preparations on the extremities 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
  * Cryotherapy within 2 weeks of initiation of treatment
  * Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of initiation of treatment
  * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, 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: Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA
timeFrame: 2 days
measure: Time at Which Cmax is Attained (Tmax) for ALA
timeFrame: 2 days
measure: AUCt
timeFrame: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24 hours post-dose
measure: The Terminal Exponential Half-life (T1/2,z) for ALA
timeFrame: 2 days
measure: Maximum Baseline Corrected Plasma Concentration (Cmax) for PpIX
timeFrame: 2 days
measure: Time at Which Cmax is Attained (Tmax) for PpIX
timeFrame: 2 days
measure: AUCBL for PpIX
timeFrame: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose
measure: AUCt for PpIX
timeFrame: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose
measure: AUCt/AUCBL for PpIX
timeFrame: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose
Secondary outcomes:
measure: Hyperpigmentation
timeFrame: Baseline
measure: Hyperpigmentation
timeFrame: 24 hours after PDT
measure: Hyperpigmentation
timeFrame: Week 4
measure: Hypopigmentation
timeFrame: Baseline
measure: Hypopigmentation
timeFrame: 24 hours after PDT
measure: Hypopigmentation
timeFrame: Week 4
measure: Erythema
timeFrame: Baseline
measure: Erythema
timeFrame: 5 Minutes after PDT
measure: Erythema
timeFrame: 24 hours after PDT
measure: Erythema
timeFrame: Week 4
measure: Edema
timeFrame: Baseline
measure: Edema
timeFrame: 5 Minutes after PDT
measure: Edema
timeFrame: 24 hours after PDT
measure: Edema
timeFrame: Week 4
measure: Stinging/Burning
timeFrame: Baseline
measure: Stinging/Burning
timeFrame: Intraprocedure
measure: Stinging/Burning
timeFrame: 5 Minutes after photodynamic therapy
measure: Stinging/Burning
timeFrame: 24 hours after PDT
measure: Stinging/Burning
timeFrame: Week 4
measure: Scaling and Dryness
timeFrame: Baseline
measure: Scaling and Dryness at Visit 4
timeFrame: 24 hours after PDT
measure: Scaling and Dryness
timeFrame: Week 4
measure: OOZING/VESICULATION/CRUSTING
timeFrame: Baseline
measure: OOZING/VESICULATION/CRUSTING
timeFrame: 24 hours after PDT
measure: OOZING/VESICULATION/CRUSTING
timeFrame: Week 4
Other outcomes:
Locations:
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: College Station
country: United States
facility: J&J Studies, Inc
state: Texas
Study officials:
affiliation: DUSA Pharmaceuticals, Inc.
name: Stuart Marcus, MD, PhD
role: STUDY_DIRECTOR
References: