Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face

Completed · Phase 2

Conditions studied: Actinic Keratosis

In brief

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.

Key facts

Study ID

NCT02632110

Run by

DUSA Pharmaceuticals, Inc.

People needed

137

Starts

2016-03-01

Expected to finish

2016-09-12

Last updated by the study team

2018-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Four to eight AKs on the face

You may not qualify if…

• 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

Where it is running

• UCSD Dermatology — San Diego, California, United States
• Therapeutics Clinical Research — San Diego, California, United States
• MOORE Clinical Research, Inc — Brandon, Florida, United States
• Altman Dermatology Associates — Arlington Heights, Illinois, United States
• Shideler Clinical Research Center — Carmel, Indiana, United States
• The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Virginia Clinical Research, Inc. — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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