Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Photosensitizing Agents

10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.

20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.

The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length.

Microneedle Roller

Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA

Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA

Blue Light

Raja Sivamani, M.D.

The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.

The current standard of care of photodynamic therapy to treat actinic keratoses includes pre-treatment of the area with topical aminolevulinic acid for 1 hour, followed by treatment with blue light. In a previous study, the investigators showed pretreatment of microneedles enhance penetration of topical aminolevulinic acid as compared to the control group.

The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.

The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

The primary endpoint will be the difference in the percentage of complete clearance of the actinic keratoses as an intraindividual comparison between the treatment groups.

The secondary will be any pain associated with the microneedle pretreatment and with the application of the PDT using the 100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

University of California, Davis

10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.

Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.

Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA

Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA

10-minute Incubation With Microneedle Roller & Sham

20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.

Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.

Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA

Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA

20-minute Incubation With Microneedle Roller & Sham

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

In each group we initially enrolled 16 participants. In the 20 minute incubation group, we had 1 dropout which left us with 15 participants that finished.

Tatyana Petukhova MD

10-minute Incubation With Microneedle Roller

20-minute Incubation With Microneedle Roller

10-minute topical aminolevulinic acid incubation group. Binary randomization of subjects into treatment groups and secondary binary randomization for application of the microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.

Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA

Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA

10-minute Incubation With Sham Microneedles

20-minute topical aminolevulinic acid incubation group. Binary randomization of subjects into treatment groups and secondary binary randomization for application of the microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.

Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA

Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA

20-minute Incubation With Sham Microneedles

Difference in the Percentage of Complete Clearance of the Actinic Keratoses

Pain_microneedle: 10-minute Incubation With Microneedle Roller

Pain_microneedle: 20-minute Incubation With Microneedle Roller

Pain_microneedle: 10-minute Incubation With Microneedle Sham

Pain_microneedle: 20-minute Incubation With Microneedle Sham

10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.

Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.

Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA

Pain_PDT: 10-minute Incubation With Microneedle Sham

Pain_PDT: 10-minute Incubation With Microneedle Roller

20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.

Microneedle Roller: The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 200 micrometers in length.

Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA Blue Light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA

Pain_PDT: 20-minute Incubation With Microneedle Sham

Pain_PDT: 20-minute Incubation With Microneedle Roller

Visual Analog Pain Scale

Overall Study

Anti-Allergic Agents

Histamine Antagonists

Histamine H1 Antagonists

Cetirizine

Histamine

Histamine phosphate

Histamine H1 Antagonists, Non-Sedating

Neurotransmitter Agents

Prophylactic use of cetirizine hydrochloride prior to and after Topical 5-aminolevulinic Acid Photodynamic Therapy

Prophylactic use of placebo prior to and after Topical 5-aminolevulinic Acid Photodynamic Therapy

Prophylactic use of antihistamine prior to and following topical 5-aminolevulonic acid photodynamic therapy

Antihistamine Cetirizine Hydrochloride

Use of placebo prior to and following topical 5-aminolevulonic acid photodynamic therapy

Placebo

Mitchel P Goldman, MD

A double-blind, placebo controlled study conducted at a single study site. Evaluating the role of systemic antihistamine therapy in the reduction of adverse effects associated with topical 5-aminolevulinic acid photodynamic therapy.

A Clinical Trial Evaluating the Role of Systemic Antihistamine Therapy in the Reduction of Adverse Effects Associated With Topical 5-aminolevulinic Acid Photodynamic Therapy

A Randomized, Double-blind, Placebo-controlled, Prospective Clinical Trial Evaluating the Role of Systemic Antihistamine Therapy in the Reduction of Adverse Effects Associated With Topical 5-aminolevulinic Acid Photodynamic Therapy

Localized Skin Response consisting of erythema, edema, crusting, exudation, Vesiculation/Pustulation and erosion/ ulceration Investigator evaluated on a standardized scale

DUSA Pharmaceuticals, Inc.

Goldman, Butterwick, Fitzpatrick and Groff

The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.

Microneedle

Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)

Blue light

Raja K Sivamani, MD

The global aim of this study is to investigate how microneedles can facilitate the penetration and efficacy of photodynamic therapy in the treatment of actinic keratoses

The specific aims are as follows:

1. Investigate whether pretreatment with microneedles enhances penetration of topical aminolevulinic acid (ALA) that is marketed as Levulan® Kerasticks by DUSA pharmaceuticals Inc.
2. Investigate whether pretreatment with microneedles can decrease the required incubation times of the topical ALA prior to exposure to blue light photodynamic therapy.

The Use of Microneedles in Photodynamic Therapy

20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)

Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.

Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA

Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)

20 Minute Microneedle Pretreatment Incubation

40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)

Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.

Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA

Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)

40 Minute Microneedle Pretreatment Incubation

60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)

Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.

Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA

Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy	NCT02594644	Keratosis, Acti...	Microneedle Rol... Aminolevulinic ... Blue Light	18 Years -	University of California, Davis
A Clinical Trial Evaluating the Role of Systemic Antihistamine Therapy in the Reduction of Adverse Effects Associated With Topical 5-aminolevulinic Acid Photodynamic Therapy	NCT02451579	Actinic Keratos...	Antihistamine C... Placebo	19 Years -	Goldman, Butterwick, Fitzpatrick and Groff
The Use of Microneedles in Photodynamic Therapy	NCT01812837	Actinic Keratos...	Microneedle Aminolevulinic ... Blue light	18 Years -	University of California, Davis
The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy	NCT02594644	Keratosis, Acti...	Microneedle Rol... Aminolevulinic ... Blue Light	18 Years -	University of California, Davis

Spots Global Cancer Trial Database for blue light

Every month we try and update this database with for blue light cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for blue light

Every month we try and update this database with for blue light cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for blue light cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.