Phase 2
N=235
Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)
Actinic Keratosis
Bottom Line
View on ClinicalTrials.gov: NCT01475955 ↗Enrolled (actual)
235
Serious AEs
5.5%
Results posted
Dec 2013
Primary outcome: Primary: Complete Clearance Rate — 14; 7; 13; 8 participants — p=0.0041
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Broad Area ALA 1-hour incubation (Drug); Broad Area ALA 2 hour incubation (Drug); broad area ALA 3-hour incubation (Drug); Spot ALA 2 hour incubation (Drug); Vehicle PDT (Drug); Blue Light Treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- DUSA Pharmaceuticals, Inc.
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Clearance Rate |
11; 3; 12; 2; 1 | — |
| SECONDARY Complete Clearance Rate |
11; 3; 12; 2; 1 | — |
| SECONDARY Complete Clearance Rate |
11; 3; 12; 2; 1 | — |
| SECONDARY Complete Clearance Rate |
11; 3; 12; 2; 1 | — |
| SECONDARY Partial Clearance Rate |
18; 19; 24; 17; 3 | — |
| SECONDARY Partial Clearance Rate |
18; 19; 24; 17; 3 | — |
| SECONDARY Partial Clearance Rate |
18; 19; 24; 17; 3 | — |
| SECONDARY Partial Clearance Rate |
18; 19; 24; 17; 3 | — |
| SECONDARY AK Clearance Rate |
66.7; 64.9; 75.0; 63.4; 14.3 | — |
| SECONDARY AK Clearance Rate |
66.7; 64.9; 75.0; 63.4; 14.3 | — |
| SECONDARY AK Clearance Rate |
66.7; 64.9; 75.0; 63.4; 14.3 | — |
| SECONDARY AK Clearance Rate |
66.7; 64.9; 75.0; 63.4; 14.3 | — |
| SECONDARY Subject Satisfaction Score |
20; 21; 20; 20; 7; 14 | — |
| SECONDARY Hyperpigmentation at Baseline |
12; 8; 17; 14; 11; 23 | — |
| SECONDARY Hyperpigmentation at Visit 2 |
17; 12; 18; 15; 16; 19 | — |
| SECONDARY Hyperpigmentation at Visit 3 |
16; 10; 20; 16; 15; 18 | — |
| SECONDARY Hyperpigmentation at Visit 4 |
16; 11; 22; 16; 12; 21 | — |
| SECONDARY Hyperpigmentation at Visit 5 |
16; 11; 17; 14; 11; 19 | — |
| SECONDARY Hyperpigmentation at Visit 6 |
17; 9; 18; 17; 11; 18 | — |
| SECONDARY Hyperpigmentation at Visit 7 |
16; 9; 20; 18; 13; 23 | — |
| SECONDARY Hypopigmentation at Baseline |
21; 20; 30; 22; 18; 21 | — |
| SECONDARY Hypopigmentation at Visit 2 |
25; 24; 31; 23; 23; 16 | — |
| SECONDARY Hypopigmentation at Visit 3 |
25; 23; 31; 21; 20; 17 | — |
| SECONDARY Hypopigmentation at Visit 4 |
25; 20; 29; 19; 19; 17 | — |
| SECONDARY Hypopigmentation at Visit 5 |
23; 19; 28; 17; 18; 21 | — |
| SECONDARY Hypopigmentation at Visit 6 |
23; 20; 26; 19; 15; 21 | — |
| SECONDARY Hypopigmentation at Visit 7 |
22; 18; 28; 20; 17; 22 | — |
| SECONDARY Erythema at Baseline |
14; 10; 15; 19; 15; 23 | — |
| SECONDARY Erythema Post-Light Treatment |
2; 0; 0; 0; 4; 8 | — |
| SECONDARY Erythema at Visit 2 |
2; 0; 1; 0; 13; 8 | — |
| SECONDARY Erythema at Visit 3 |
11; 5; 11; 14; 15; 22 | — |
| SECONDARY Erythema at Visit 4 |
12; 13; 16; 12; 14; 27 | — |
| SECONDARY Erythema at Visit 5 (Pre-drug) |
13; 15; 17; 21; 12; 25 | — |
| SECONDARY Erythema at Visit 5 (Post-light) |
1; 0; 1; 0; 4; 8 | — |
| SECONDARY Erythema at Visit 6 |
16; 15; 18; 22; 17; 24 | — |
| SECONDARY Erythema at Visit 7 |
20; 16; 19; 27; 21; 19 | — |
| SECONDARY Edema at Baseline |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Edema Post-Light Treatment |
37; 28; 27; 33; 44; 8 | — |
| SECONDARY Edema at Visit 2 |
32; 31; 26; 27; 44; 8 | — |
| SECONDARY Edema at Visit 3 |
46; 44; 42; 44; 44; 1 | — |
| SECONDARY Edema at Visit 4 |
46; 47; 46; 46; 45; 1 | — |
| SECONDARY Edema at Visit 5 (Pre-drug) |
47; 48; 45; 46; 44; 0 | — |
| SECONDARY Edema Post PDT #2 |
32; 20; 18; 26; 43; 6 | — |
| SECONDARY Edema at Week 12 |
47; 48; 43; 46; 44; 0 | — |
| SECONDARY Edema at Week 24 |
47; 48; 43; 45; 45; 0 | — |
| SECONDARY Stinging/Burning at Baseline |
47; 48; 47; 46; 44; 0 | — |
| SECONDARY Stinging/Burning During Light Treatment |
2; 1; 0; 3; 35; 15 | — |
| SECONDARY Stinging/Burning Post Light-Treatment |
8; 5; 1; 8; 40; 29 | — |
| SECONDARY Stinging/Burning at Visit 2 |
25; 23; 20; 35; 41; 18 | — |
| SECONDARY Stinging/Burning at Visit 3 |
46; 45; 44; 46; 45; 1 | — |
| SECONDARY Stinging/Burning at Visit 4 |
45; 47; 46; 46; 44; 2 | — |
| SECONDARY Stinging/Burning at Visit 5 (Pre-drug) |
47; 48; 45; 45; 42; 0 | — |
| SECONDARY Stinging/Burning at Visit 5 During PDT#2 |
4; 1; 0; 4; 28; 20 | — |
| SECONDARY Stinging/Burning at Visit 5 Post PDT#2 |
7; 2; 2; 10; 35; 26 | — |
| SECONDARY Stinging/Burning at Visit 6 |
47; 48; 44; 44; 43; 0 | — |
| SECONDARY Stinging/Burning at Visit 7 |
47; 48; 44; 45; 46; 0 | — |
| SECONDARY Scaling and Dryness at Baseline |
25; 24; 26; 29; 16; 16 | — |
| SECONDARY Scaling and Dryness at Visit 2 |
19; 20; 22; 17; 18; 13 | — |
| SECONDARY Scaling and Dryness at Visit 3 |
22; 21; 20; 27; 19; 17 | — |
| SECONDARY Scaling and Dryness at Visit 4 |
24; 24; 27; 28; 18; 19 | — |
| SECONDARY Scaling and Dryness at Visit 5 |
23; 30; 31; 31; 17; 21 | — |
| SECONDARY Scaling and Dryness at Visit 6 |
32; 34; 30; 33; 23; 13 | — |
| SECONDARY Scaling and Dryness at Visit 7 |
31; 26; 32; 37; 28; 13 | — |
| SECONDARY Oozing/Vesiculation/Crusting at Baseline |
45; 47; 46; 43; 44; 1 | — |
| SECONDARY Oozing/Vesiculation/Crusting at Visit 2 |
43; 39; 34; 34; 43; 2 | — |
| SECONDARY Oozing/Vesiculation/Crusting at Visit 3 |
45; 42; 45; 45; 45; 1 | — |
| SECONDARY Oozing/Vesiculation/Crusting at Visit 4 |
46; 45; 46; 46; 45; 1 | — |
| SECONDARY Oozing/Vesiculation/Crusting at Visit 5 |
47; 47; 45; 44; 42; 0 | — |
| SECONDARY Oozing/Vesiculation/Crusting at Visit 6 |
46; 48; 44; 46; 44; 1 | — |
| SECONDARY Oozing/Vesiculation/Crusting at Visit 7 |
47; 48; 44; 45; 46; 0 | — |
Summary
The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.
Eligibility Criteria
Inclusion Criteria
- 6-20 Grade 1/2 AKs on the face or scalp
- a history of AK therapy within the treatment area at least twice in the two years prior to study entry
Exclusion Criteria
- Pregnancy
- Grade 3 AKs or atypical AKs (e.g., AK > 1 cm2 in size) within the Treatment Area
- lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
- plans to be exposed to artificial tanning devices or excessive sunlight during the trial
- Subject is immunosuppressed
- unsuccessful outcome from previous ALA-PDT therapy
- history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
- skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
- skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
- any condition which would make it unsafe for the subject to participate in this research study
- 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)
- Subject has;
- an active herpes simplex infection OR
- a history of 2 or more outbreaks within the past 12 months, in the Treatment Area
- 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 (NCT01475955). 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.