Maximal Use Systemic Exposure Study of Levulan Kerastick (MUSE 2)
| Status: | Recruiting |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2016 |
| End Date: | May 2016 |
| Contact: | Jim Berg |
| Email: | jberg@therapeuticsinc.com |
| Phone: | 858-571-1800 |
A Pharmacokinetic Study of Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% Under Maximal Use Conditions
The purpose of this study is to evaluate the potential for systemic exposure of
aminolevulinic acid (ALA) and protoporphyrin IX (PpIX) when applied topically under
occlusion, in a maximal use setting in patients with multiple actinic keratoses (AK)
involving the upper extremities.
aminolevulinic acid (ALA) and protoporphyrin IX (PpIX) when applied topically under
occlusion, in a maximal use setting in patients with multiple actinic keratoses (AK)
involving the upper extremities.
Inclusion Criteria:
- At least 6 Grade 1/2 AKs on one upper extremity AND
- At least 12 Grade 1/2 AKs on the OTHER 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
- Body Mass Index (BMI) > 32.0 kg/m2
- skin pathology or condition which could interfere with the evaluation of the test
product or requires the use of interfering topical or systemic therapy
- significant blood loss within 60 days or donated blood/plasma within 72 hours prior
to Visit 2 (Baseline)
- tested positive at screening for human immunodeficiency virus (HIV) or was known to
be seropositive for HIV
- a history of lead poisoning or a history of a significant exposure to lead
- tested positive at screening for hepatitis B surface antigen, hepatitis C antibody or
had a history of a positive result
- positive drug screen at Screening
- Screening safety labs are clinically significant in the opinion of the investigator
- major surgery within 30 days prior to Visit 2 (Baseline) or plans to have surgery
during the study
- 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 Visit 2 (Baseline)
- 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
- use of systemic retinoid therapy within 6 months of initiation of treatment
We found this trial at
2
sites
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College Station, Texas 77845
Principal Investigator: Terry Jones, MD
Phone: 979-774-5933
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