Clinical trial NCT02239679: Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy
Official title: A Phase 2 Study Comparing the Occurrence of Actinic Keratoses on the Face in High-Risk Individuals After Cryotherapy + Photodynamic Therapy With Levulan Topical Solution + Blue Light Versus Cryotherapy + Vehicle Topical Solution + Blue Light
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Lead sponsor: DUSA Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-09-15
Enrollment: 166
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 determine if Levulan photodynamic therapy (PDT) is safe and effective in the treatment of actinic keratoses (AK) on the face, following treatment with liquid nitrogen cryotherapy.


Eligibility criteria: Inclusion Criteria:

* Four to fifteen AKs on the face
* histologically confirmed presence of abnormal architecture and satellite atypical keratinocytes in the epidermis, in clinically normal tissue samples of photodamaged skin adjacent to AKs
* at least one previously treated nonmelanoma skin cancer (NMSC) on the head and/or neck area within the past five years

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
* 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 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
  * Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks
  * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-fluorouracil (5-FU), diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks
* use of systemic retinoid therapy within 6 months

Primary outcomes:
measure: Total Number of AKs in Treatment Area
timeFrame: Week 52
Secondary outcomes:
measure: Proportion of Subjects With 0 AKs
timeFrame: Week 4
measure: Subject Satisfaction Score
timeFrame: Week 52
measure: Proportion of Subjects With 0 AKs
timeFrame: Week 12
measure: Proportion of Subjects With 0 AKs
timeFrame: Week 24
measure: Proportion of Subjects With 0 AKs
timeFrame: Week 36
measure: Proportion of Subjects With 0 AKs
timeFrame: Week 52
measure: Recurrence Rate
timeFrame: Week 52
measure: Duration of Response
timeFrame: within 52 weeks after Baseline
Other outcomes:
measure: Hyperpigmentation
timeFrame: Screening
measure: Hyperpigmentation
timeFrame: Baseline
measure: Hyperpigmentation
timeFrame: 24-48 hours after photodynamic therapy (PDT) #1
measure: Hyperpigmentation
timeFrame: 4 Weeks after PDT #1
measure: Hyperpigmentation
timeFrame: 12 Weeks after PDT #1
measure: Hyperpigmentation
timeFrame: 24 Weeks after PDT #1
measure: Hyperpigmentation
timeFrame: 36 Weeks after PDT #1
measure: Hyperpigmentation
timeFrame: 52 Weeks after PDT #1
measure: Hypopigmentation
timeFrame: Screening
measure: Hypopigmentation
timeFrame: Baseline
measure: Hypopigmentation
timeFrame: 24-48 hours after PDT #1
measure: Hypopigmentation
timeFrame: 4 Weeks after PDT #1
measure: Hypopigmentation
timeFrame: 12 Weeks after PDT #1
measure: Hypopigmentation
timeFrame: 24 Weeks after PDT #1
measure: Hypopigmentation
timeFrame: 36 Weeks after PDT #1
measure: Hypopigmentation
timeFrame: 52 Weeks after PDT #1
measure: Erythema
timeFrame: Screening
measure: Erythema
timeFrame: Baseline
measure: Erythema
timeFrame: 5 minutes after PDT #1
measure: Erythema
timeFrame: 24-48 hours after PDT #1
measure: Erythema
timeFrame: 4 Weeks after PDT #1
measure: Erythema
timeFrame: 12 Weeks after PDT #1
measure: Erythema
timeFrame: 24 Weeks after PDT #1
measure: Erythema
timeFrame: 36 Weeks after PDT #1
measure: Erythema
timeFrame: 52 Weeks after PDT #1
measure: Edema
timeFrame: Screening
measure: Edema
timeFrame: Baseline
measure: Edema
timeFrame: 5 minutes after PDT #1
measure: Edema
timeFrame: 24-48 hours after PDT #1
measure: Edema
timeFrame: 4 Weeks after PDT #1
measure: Edema
timeFrame: 12 Weeks after PDT #1
measure: Edema
timeFrame: 24 weeks after PDT #1
measure: Edema
timeFrame: 36 Weeks after PDT #1
measure: Edema
timeFrame: 52 Weeks after PDT #1
measure: Stinging/Burning
timeFrame: Screening
measure: Stinging/Burning
timeFrame: Baseline
measure: Stinging/Burning
timeFrame: During PDT #1
measure: Stinging/Burning
timeFrame: 5 minutes after PDT #1
measure: Stinging/Burning
timeFrame: 24-48 hours after PDT #1
measure: Stinging/Burning
timeFrame: 4 Weeks after PDT #1
measure: Stinging/Burning
timeFrame: 12 Weeks after PDT #1
measure: Stinging/Burning
timeFrame: 24 Weeks after PDT #1
measure: Stinging/Burning
timeFrame: 36 Weeks after PDT #1
measure: Stinging/Burning
timeFrame: 52 Weeks after PDT #1
measure: Scaling & Dryness
timeFrame: Screening
measure: Scaling & Dryness
timeFrame: Baseline
measure: Scaling & Dryness
timeFrame: 24-48 hours after PDT #1
measure: Scaling & Dryness
timeFrame: 4 Weeks after PDT #1
measure: Scaling & Dryness
timeFrame: 12 Weeks after PDT #1
measure: Scaling & Dryness
timeFrame: 24 Weeks after PDT #1
measure: Scaling & Dryness
timeFrame: 36 Weeks after PDT #1
measure: Scaling & Dryness
timeFrame: 52 Weeks after PDT #1
measure: Oozing/Vesiculation/Crusting
timeFrame: Screening
measure: Oozing/Vesiculation/Crusting
timeFrame: Baseline
measure: Oozing/Vesiculation/Crusting
timeFrame: 24-48 hours after PDT #1
measure: Oozing/Vesiculation/Crusting
timeFrame: 4 Weeks after PDT #1
measure: Oozing/Vesiculation/Crusting
timeFrame: 12 Weeks after PDT #1
measure: Oozing/Vesiculation/Crusting
timeFrame: 24 Weeks after PDT #1
measure: Oozing/Vesiculation/Crusting
timeFrame: 36 Weeks after PDT #1
measure: Oozing/Vesiculation/Crusting
timeFrame: 52 Weeks after PDT #1
Locations:
city: San Diego
country: United States
facility: UCSD Dermatology
state: California
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: New York
country: United States
facility: Sadick Research Group
state: New York
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Houston
country: United States
facility: Suzanne Bruce and Associates, P.A.,The Center for Skin Research
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: