Phase 2
N=274
Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face
Actinic Keratosis
Bottom Line
View on ClinicalTrials.gov: NCT02632110 ↗Enrolled (actual)
274
Serious AEs
0.7%
Results posted
Dec 2017
Primary outcome: Primary: Complete Clearance Rate — 16; 15; 10; 12 AK Fields
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ALA (Drug); Topical Solution Vehicle (Drug); IBL 10 mW (Device); Microneedle lesion preparation (Procedure); IBL 20 mW (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- DUSA Pharmaceuticals, Inc.
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Clearance Rate |
5; 7; 7; 7; 13; 11 | — |
| SECONDARY Complete Clearance Rate |
5; 7; 7; 7; 13; 11 | — |
| SECONDARY Subject Satisfaction Score |
15; 13; 21; 21; 18; 18 | — |
| SECONDARY Baseline AKCR |
92.2; 89.2; 82.3; 86.7; 93.2; 95.1 | — |
| SECONDARY Baseline AKCR |
92.2; 89.2; 82.3; 86.7; 93.2; 95.1 | — |
| SECONDARY Percent Change |
-87.0; -87.3; -75.0; -80.0; -88.9; -87.4 | — |
| SECONDARY Percent Change |
-87.0; -87.3; -75.0; -80.0; -88.9; -87.4 | — |
Summary
The purpose of this study is to determine the viability of microneedle lesion preparation (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis (AK) field on the face.
Eligibility Criteria
Inclusion Criteria
- Four to eight AKs on the face
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
- 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
- Curettage or Cryotherapy within 2 weeks of initiation of treatment
- Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks
- Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5 fluorouracil, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks
- use of systemic retinoid therapy within 6 months
Data sourced from ClinicalTrials.gov (NCT02632110). 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.