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Trial record 36 of 51 for:    tazarotene

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

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ClinicalTrials.gov Identifier: NCT01053000
Recruitment Status : Completed
First Posted : January 21, 2010
Results First Posted : July 22, 2015
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
Barry Galitzer, MD, Stewart, Roger H., M.D., P.A.

Tracking Information
First Submitted Date  ICMJE January 19, 2010
First Posted Date  ICMJE January 21, 2010
Results First Submitted Date  ICMJE May 16, 2014
Results First Posted Date  ICMJE July 22, 2015
Last Update Posted Date August 11, 2015
Study Start Date  ICMJE January 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2015)
Change in Lesion Counts in 25 cm2 Target Area Relative to Baseline. [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 19, 2010)
Change in lesion counts in 25 cm2 Target Area relative to Baseline. Tolerability of treatment, local and systemic adverse events. [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT01053000 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photodynamic Therapy With Levulan® +/- Topical Retinoid Pre-Treatment In The Treatment Of Actinic Keratoses
Official Title  ICMJE Photodynamic Therapy With Levulan® Topical Solution And Blue Light +/- Topical Retinoid Pre-Treatment In The Treatment Of Dorsal Hand/Forearm Actinic Keratoses
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.
Detailed Description Subjects will be randomized such that their RIGHT dorsal hand/forearm will receive one of the following two treatments with the subject's LEFT dorsal hand/forearm receiving the other treatment; Treatment 1 will include pre-treatment of the dorsal hand/forearm with Tazorac 0.1% gel BID for one week, followed by ALA applied to the entire dorsal hand/forearm 60 minutes prior to BLUE light treatment for 16 minutes 40 seconds Treatment 2 will have ALA applied to the entire dorsal hand/forearm and occluded for 60 minutes prior to BLUE light treatment for 16 minutes 40 secondsNote: ALA will be applied to individual dorsal hand/forearm actinic keratoses (AK) lesions followed by broad area application over the entire dorsal hand/forearm surface. The treatment area on the side NOT pre-treated with Tazorac will then be occluded using plastic wrap for 60 minutes. The treatment area of the dorsal hand/forearm is defined as the extensor surface of the hand/forearm between the elbow and the base of the fingers (the fingers are NOT included in the treatment area).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE ACTINIC KERATOSES
Intervention  ICMJE Drug: Tazorac
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.
Other Name: tazarotene
Study Arms  ICMJE
  • Experimental: Lt. Arm Tazorac/Rt. Arm No Pretreatment
    Apply Tazorac 0.1% gel for 1 week to the Left arm only and then receive ALA- PDT Treatment to both arms
    Intervention: Drug: Tazorac
  • Experimental: Rt. Arm Tazorac/Lt. Arm No Pretreatment
    Apply Tazorac 0.1% gel for 1 week to the Right arm only and then receive ALA- PDT Treatment to both arms
    Intervention: Drug: Tazorac
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2010)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. 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.

3. 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.

4. Subject is willing to comply with study instructions and return to the clinic for required visits.

Exclusion Criteria:

  • 1. Subject is pregnant, lactating, or is planning to become pregnant during the study.

    2. 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.).

    3. 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.

    4. Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.

    5. 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).

    7. Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.

    8. 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.

    9. Subject has a known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol).

    10. 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).

    11. Subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.

    12. 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.

    13. 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.

    14. 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01053000
Other Study ID Numbers  ICMJE INV-0901
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Barry Galitzer, MD, Stewart, Roger H., M.D., P.A.
Study Sponsor  ICMJE Stewart, Roger H., M.D., P.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barry Galitzer, MD Roger H. Stewart MD PA
PRS Account Stewart, Roger H., M.D., P.A.
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP