Phase 2 N=166 Randomized Double-blind Treatment

Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy

Actinic Keratosis

Bottom Line

View on ClinicalTrials.gov: NCT02239679 ↗

Enrolled (actual)

166

Serious AEs

4.2%

Results posted

Sep 2017

Primary outcome: Primary: Total Number of AKs in Treatment Area — 3.0; 2.1; 4.7 lesions — p=0.0166

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Aminolevulinic Acid (Drug); Topical Solution Vehicle (Drug); BLU-U (Device); Cryotherapy (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: DUSA Pharmaceuticals, Inc.
Primary completion: Jul 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Number of AKs in Treatment Area	3.0; 2.1; 4.7	0.0166 sig
SECONDARY Proportion of Subjects With 0 AKs	18; 21; 10	0.0102 sig
SECONDARY Subject Satisfaction Score	27; 26; 16; 15; 21; 14	—
SECONDARY Proportion of Subjects With 0 AKs	18; 21; 10	0.0102 sig
SECONDARY Proportion of Subjects With 0 AKs	18; 21; 10	0.0102 sig
SECONDARY Proportion of Subjects With 0 AKs	18; 21; 10	0.0102 sig
SECONDARY Proportion of Subjects With 0 AKs	18; 21; 10	0.0102 sig
SECONDARY Recurrence Rate	34; 32; 81	0.0004 sig
SECONDARY Duration of Response	35.9; 33.3; 25.9	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02239679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.