Photodynamic Therapy With Levulan® +/- Topical Retinoid Pre-Treatment In The Treatment Of Actinic Keratoses

NCT01053000 | Completed Results

• 1 other identifier: INV-0901
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To determine and compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment vs ALA-PDT with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.

Conditions

ACTINIC KERATOSES

Keywords

ACTINIC KERATOSES; HAND; FOREARM

Outcome Measures

Primary Outcomes (1)

• Change in Lesion Counts in 25 cm2 Target Area Relative to Baseline.

  12 weeks

Study Arms (2)

Lt. Arm Tazorac/Rt. Arm No Pretreatment

EXPERIMENTAL

Apply Tazorac 0.1% gel for 1 week to the Left arm only and then receive ALA- PDT Treatment to both arms

Drug: Tazorac

Rt. Arm Tazorac/Lt. Arm No Pretreatment

EXPERIMENTAL

Apply Tazorac 0.1% gel for 1 week to the Right arm only and then receive ALA- PDT Treatment to both arms

Drug: Tazorac

Interventions

Tazorac DRUG

compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment with Tazorac vs ALA-PDT with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.

Also known as: tazarotene

Lt. Arm Tazorac/Rt. Arm No Pretreatment; Rt. Arm Tazorac/Lt. Arm No Pretreatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subject is male or non-pregnant female over the age of 18 years. Females must be post-menopausal, surgically sterile or using a medically acceptable form of birth control, with a negative urine pregnancy test at the Baseline visit. 2. Subject has provided written and verbal informed consent.
• \. Subject has at least four (4) AK lesions (Grade 1 or 2) on each Treatment Area (dorsal forearm/hand surface), with at least 3 of these lesions in a continuous 25 cm2 Target Area on the hand or forearm.
• \. Subject is willing to comply with study instructions and return to the clinic for required visits.

You may not qualify if:

• \. Subject is pregnant, lactating, or is planning to become pregnant during the study.
• \. Subject has a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis or any condition with associated immunosuppression (e.g. HIV, systemic malignancy, etc.).
• \. Subject has any skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy.
• \. Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
• \. Subject is currently enrolled in an investigational drug or device study. 6. Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment (baseline).
• \. Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
• \. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
• \. Subject has a known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol).
• \. Subject has a known sensitivity to one or more of the components of Tazorac (tazarotene, benzyl alcohol, ascorbin acid, butylated hydroxyanisole, butylated hydroxytoluene, carbomer 934P, edentate disodium, hexylene glycol, poloxamer 407, polyethylene glycol 400, polysorbate 40, tromethamine).
• \. Subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
• \. Subject has used photosensitizing drugs, (e.g. thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides, etc) within a timeframe where photosensitization from these drugs may still be present, or has the need to use them during the trial.
• \. Subject has used any of the following topical preparations on the dorsal hands/forearms:· 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. · Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of the initiation of treatment.· 5-FU, cryotherapy, diclofenac, imiquimod or other treatments for AK within 8 weeks of initiation of treatment.· Microdermabrasion, laser ablative treatments or chemical peels within 8 weeks of the initiation of treatment. · ALA-PDT within 6 months of initiation of treatment.
• \. Subject has used any of the following systemic medications: · Immuno-suppressants including steroids, chemotherapy, etc. within 3 months of the initiation of treatment· Retinoid therapy within 6 months of the initiation of treatment.

Sponsors & Collaborators

• Stewart, Roger H., M.D., P.A.: lead

Study Sites (1)

Roger Stewart MD PA

Fort Lauderdale, Florida, 33308, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

tazarotene

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Barry Galitzer MD
• Organization: Roger H. Stewart MD PA

barry@galitzer.com

954-491-0510

Study Officials

• Barry Galitzer, MD

  Roger H. Stewart MD PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: January 19, 2010
• First Posted: January 21, 2010
• Study Start: January 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 11, 2015
• Results First Posted: July 22, 2015

Record last verified: 2015-07

Locations

US (1)