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NCT01812837 Clinical Trial

The Use of Microneedles in Photodynamic Therapy

Actinic Keratosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01812837
Other study ID # 282150
Secondary ID
Status Completed
Phase N/A
First received March 13, 2013
Last updated June 18, 2014
Start date July 2012
Est. completion date March 2014

Study information
Verified date June 2014
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Subjects who are 18 and older

2. Subjects who have at least 3 actinic keratoses on each side of the forehead

3. Subjects who signed an IRB approved informed consent

Exclusion Criteria:

1. Subjects who smoke

2. Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition.

3. Subjects who received a diagnosis of skin cancer on the face in past year

4. Subjects who received field treatment for actinic keratoses to the face in the past 60 days

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• 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.
Drug:
• Aminolevulinic Acid
Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
Radiation:
• Blue light
Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)

Locations
Country Name City State
United States UC Davis, Dermatology Sacramento California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary complete response rate one month after treatment No
See also
  Status Clinical Trial Phase
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Completed NCT02674048 - Metvix Daylight PDT in Actinic Keratosis
Completed NCT02421471 - PMS to Evaluate the Safety and Efficacy of Picato® Gel
Completed NCT02239679 - Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy Phase 2
Completed NCT01686152 - Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis Phase 3
Completed NCT01449513 - PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy Phase 1
Completed NCT01444989 - Development and Validation of a Quality of Life Instrument for Actinic Keratosis N/A
Terminated NCT01525329 - Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease Phase 3
Terminated NCT01203878 - Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy Phase 4
Completed NCT00989313 - A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study Phase 3
Completed NCT00306800 - Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp Phase 3
Completed NCT00375739 - Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses Phase 2
Completed NCT03285490 - A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004) Phase 3
Completed NCT03319251 - Biomarker Database Registry for Photodynamic Therapy
Completed NCT02866695 - Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients Phase 4
Completed NCT02952898 - Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses Phase 3
Completed NCT02984072 - Menthol for PDT Pain Relief Phase 4
Recruiting NCT03684772 - Topical Ionic Contra-Viral Therapy in Actinic Keratosis Phase 2
Completed NCT02878382 - Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT N/A
Completed NCT02938715 - Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil N/A

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