Phase 2
N=70
Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)
Keratosis, Actinic
Bottom Line
View on ClinicalTrials.gov: NCT01458587 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Lesion Clearance Rate — 88.7; 70.0; 16.7; 5.6 percentage of lesions cleared
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Aminolevulinic Acid PDT (ALA) (Drug); Vehicle PDT (VEH) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- DUSA Pharmaceuticals, Inc.
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lesion Clearance Rate |
75.0; 47.4; 3.3; 6.3 | — |
| SECONDARY Lesion Clearance Rate |
75.0; 47.4; 3.3; 6.3 | — |
| SECONDARY Complete Clearance Rate |
12; 7; 0; 1 | — |
| SECONDARY Complete Clearance Rate |
12; 7; 0; 1 | — |
| SECONDARY Partial Clearance Rate |
21; 15; 3; 2 | — |
| SECONDARY Partial Clearance Rate |
21; 15; 3; 2 | — |
| SECONDARY Subject Satisfaction Score |
13; 7; 3; 1; 16; 14 | — |
| SECONDARY Hyperpigmentation at Baseline |
5; 5; 1; 1; 20; 19 | — |
| SECONDARY Hyperpigmentation at Visit 3 |
4; 4; 1; 1; 19; 20 | — |
| SECONDARY Hyperpigmentation at Visit 4 |
2; 2; 0; 0; 24; 21 | — |
| SECONDARY Hyperpigmentation at Visit 5 |
2; 2; 0; 0; 25; 23 | — |
| SECONDARY Hypopigmentation at Baseline |
9; 9; 8; 8; 21; 21 | — |
| SECONDARY Hypopigmentation at Visit 3 |
10; 10; 7; 7; 20; 20 | — |
| SECONDARY Hypopigmentation at Visit 4 |
13; 10; 9; 9; 18; 21 | — |
| SECONDARY Hypopigmentation at Visit 5 |
10; 8; 12; 11; 22; 24 | — |
| SECONDARY Erythema at Baseline |
10; 10; 12; 12; 16; 16 | — |
| SECONDARY Erythema Post-Light Treatment |
0; 0; 4; 4; 0; 4 | — |
| SECONDARY Erythema at Visit 3 |
0; 4; 10; 10; 8; 14 | — |
| SECONDARY Erythema at Visit 4 |
7; 6; 10; 11; 17; 20 | — |
| SECONDARY Erythema at Visit 5 |
9; 7; 11; 12; 7; 12 | — |
| SECONDARY Edema at Baseline |
35; 35; 35; 35; 0; 0 | — |
| SECONDARY Edema Post-Light Treatment |
28; 33; 34; 34; 5; 2 | — |
| SECONDARY Edema at Visit 3 |
27; 34; 35; 35; 5; 1 | — |
| SECONDARY Edema at Visit 4 |
35; 35; 34; 34; 0; 0 | — |
| SECONDARY Edema at Visit 5 |
33; 33; 35; 35; 0; 0 | — |
| SECONDARY Stinging/Burning at Baseline |
35; 35; 35; 35; 0; 0 | — |
| SECONDARY Stinging/Burning During Light Treatment |
0; 0; 29; 29; 5; 20 | — |
| SECONDARY Stinging/Burning Post Light Treatment |
0; 2; 30; 33; 7; 22 | — |
| SECONDARY Stinging/Burning at Visit 3 |
31; 35; 35; 35; 4; 0 | — |
| SECONDARY Stinging/Burning at Visit 4 |
35; 35; 34; 34; 0; 0 | — |
| SECONDARY Stinging/Burning at Visit 5 |
33; 33; 35; 35; 0; 0 | — |
| SECONDARY Scaling and Dryness at Baseline |
16; 16; 17; 17; 15; 15 | — |
| SECONDARY Scaling and Dryness at Visit 3 |
3; 5; 10; 11; 5; 17 | — |
| SECONDARY Scaling and Dryness at Visit 4 |
16; 17; 14; 14; 14; 12 | — |
| SECONDARY Scaling and Dryness at Visit 5 |
18; 17; 12; 12; 12; 13 | — |
| SECONDARY OOZING/VESICULATION/CRUSTING at Baseline |
35; 35; 35; 35; 0; 0 | — |
| SECONDARY OOZING/VESICULATION/CRUSTING at Visit 3 |
33; 34; 34; 34; 1; 0 | — |
| SECONDARY OOZING/VESICULATION/CRUSTING at Visit 4 |
35; 35; 34; 34; 0; 0 | — |
| SECONDARY OOZING/VESICULATION/CRUSTING at Visit 5 |
33; 32; 35; 35; 0; 1 | — |
Summary
The purpose of this study is to determine if Levulan PDT is safe and effective in the treatment of actinic keratoses on the upper arms and hands.
Eligibility Criteria
Inclusion Criteria
- At least 4 Grade 1/2 AKs on each 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
- 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)
- 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.
- Two or more ALA PDT treatments in the past 6 months
- use of systemic retinoid therapy within 6 months of initiation of treatment.
Data sourced from ClinicalTrials.gov (NCT01458587). 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.