Maximal Use Systemic Exposure Study of Levulan Kerastick (MUSE 2)

NCT02628236 | Completed Phase 2 Results

• 1 other identifier: CP0113
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Keratosis, Actinic

Keywords

Actinic keratosis

Outcome Measures

Primary Outcomes (9)

• Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA

  Maximum baseline corrected plasma concentration (Cmax) for ALA over the 24 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.

  2 days

• Time at Which Cmax is Attained (Tmax) for ALA

  Time of the maximum baseline corrected plasma concentration for ALA measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.

  2 days

• AUCt

  AUCt is the area under the baseline corrected plasma concentration-time profile up to the last quantifiable/non-negative plasma concentration

  0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24 hours post-dose

• The Terminal Exponential Half-life (T1/2,z) for ALA

  The terminal slope was calculated by linear least squares regression of the log plasma concentration-time data. The terminal exponential half-life (T1/2,z) will be calculated as 0.693 divided by the absolute value of slope.

  2 days

• Maximum Baseline Corrected Plasma Concentration (Cmax) for PpIX

  Maximum baseline corrected plasma concentration (Cmax) for PpIX over the 48 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.

  2 days

• Time at Which Cmax is Attained (Tmax) for PpIX

  Time of the maximum baseline corrected plasma concentration for PpIX measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.

  2 days

• AUCBL for PpIX

  The area under the concentration time-curve assuming the baseline observed plasma concentration existed from time 0 to tlast.

  0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose

• AUCt for PpIX

  The area under the observed plasma concentration time-curve from time 0 to the last quantifiable plasma concentration.

  0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose

• AUCt/AUCBL for PpIX

  The ratio of AUCt to AUCBL for PpIX

  0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose

Secondary Outcomes (25)

• Hyperpigmentation

  Baseline

• Hyperpigmentation

  24 hours after PDT

• Hyperpigmentation

  Week 4

• Hypopigmentation

  Baseline

• Hypopigmentation

  24 hours after PDT

Study Arms (1)

ALA

EXPERIMENTAL

20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment

Drug: Aminolevulinic Acid (ALA); Device: BLU-U

Interventions

Aminolevulinic Acid (ALA) DRUG

20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light

Also known as: Levulan Kerastick

ALA

BLU-U DEVICE

10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2

Also known as: Blue Light Photodynamic Therapy (PDT)

ALA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• DUSA Pharmaceuticals, Inc.: lead

Study Sites (2)

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

J&J Studies, Inc

College Station, Texas, 77845, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Aminolevulinic Acid; Photochemotherapy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Results Point of Contact

• Title: Anna Houlihan
• Organization: DUSA Pharmaceuticals Inc., a Sun Pharma Co.

Anna.Houlihan@sunpharma.com

8452681943

Study Officials

• Stuart Marcus, MD, PhD

  DUSA Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 11, 2015
• Study Start: February 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 18, 2017
• Results First Posted: September 18, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)