Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 36 of 51 for:    tazarotene

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition ACTINIC KERATOSES
Intervention Drug: Tazorac
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Left Arm Tazorac/Right Arm No Tazorac Pre-treatment Right Arm Tazorac/Left Arm No Pretreatment
Hide Arm/Group Description Tazorac 0.1% gel was applied for 1 week to the left arm followed by therapy with aminolevulinic acid (ALA-PDT) to both arms, in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light. Tazorac 0.1% gel was applied for 1 week to the right arm followed by therapy with aminolevulinic acid (ALA-PDT) to both arms, in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.
Period Title: Overall Study
Started 5 5
Completed 5 5
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description

Tazorac o.1% gel foer 1 week to the randomly chosen arm

20% aminolevulinic acid HCL: 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.

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  70.0%
>=65 years
3
  30.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
75.4  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
3
  30.0%
Male
7
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Change in Lesion Counts in 25 cm2 Target Area Relative to Baseline.
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tazorac Treated Arm No Pretreatment With Tzorac
Hide Arm/Group Description:

Tazorac o.1% gel for 1 week to the randomly chosen arm

20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.

No pretreatmnet to the randomly chosen arm

20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: lesions
-72  (30.3) -37.5  (41.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tazorac Treated Arm No Pretreatment Arm
Hide Arm/Group Description

Tazorac o.1% gel for 1 week to the randomly chosen arm

20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.

No Pretreatment to the randomly chosen arm

20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (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.

All-Cause Mortality
Tazorac Treated Arm No Pretreatment Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tazorac Treated Arm No Pretreatment Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tazorac Treated Arm No Pretreatment Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Barry Galitzer MD
Organization: Roger H. Stewart MD PA
Phone: 954-491-0510
EMail: barry@galitzer.com
Layout table for additonal information
Responsible Party: Barry Galitzer, MD, Stewart, Roger H., M.D., P.A.
ClinicalTrials.gov Identifier: NCT01053000     History of Changes
Other Study ID Numbers: INV-0901
First Submitted: January 19, 2010
First Posted: January 21, 2010
Results First Submitted: May 16, 2014
Results First Posted: July 22, 2015
Last Update Posted: August 11, 2015