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Photodynamic Therapy Incubation Times for Actinic Keratosis

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ClinicalTrials.gov Identifier: NCT03066843
Recruitment Status : Active, not recruiting
First Posted : February 28, 2017
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

Brief Summary:

This is a randomized clinical trial evaluating blue light 5-aminolevulinic acid (ALA) photodynamic therapy with different incubation times for the treatment of actinic keratosis.

Subjects who are interested in participating, currently living in the Chicago metropolitan area, and meet inclusion and exclusion criteria will be enrolled in the study. Subjects will be randomized to either 1) zero time ALA incubation or 2) 1 hour ALA incubation. Demographic and health data will be collected prior to treatment initiation. Three visits will be conducted: screening, treatment, and follow up visit at 8 weeks.

This study is a pilot study designed to determine feasibility of this procedure.


Condition or disease Intervention/treatment Phase
Actinic Keratoses Drug: ALA (5-aminolevulinic acid) Device: Blue light therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Evaluating 5-aminolevulinic Acid Photodynamic Therapy With Different Incubation Times for the Treatment of Actinic Keratosis
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Zero incubation with ALA (5-aminolevulinic acid)
Subjects will receive zero time of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy.
Drug: ALA (5-aminolevulinic acid)
ALA (5-aminolevulinic acid) will be applied to subjects' skin for either zero time incubation or one hour incubation
Other Name: Levulon kerastick

Device: Blue light therapy
Subjects will be exposed to blue light
Other Name: BLU-U® Blue Light Photodynamic Therapy Illuminator

Experimental: One hour incubation with ALA (5-aminolevulinic acid)
Subjects will receive one hour of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy.
Drug: ALA (5-aminolevulinic acid)
ALA (5-aminolevulinic acid) will be applied to subjects' skin for either zero time incubation or one hour incubation
Other Name: Levulon kerastick

Device: Blue light therapy
Subjects will be exposed to blue light
Other Name: BLU-U® Blue Light Photodynamic Therapy Illuminator




Primary Outcome Measures :
  1. Change in number of Actinic Keratosis (AK) lesions [ Time Frame: Baseline and 8 Weeks ]
    The number of AK lesions will be counted by a live, blinded assessor at baseline and at Week 8 follow-up visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects who have been diagnosed with actinic keratosis.
  2. Subjects who by the investigator deem to be suitable for photodynamic therapy of the face or scalp.
  3. Males or females ≥ 18 years old
  4. Fitzpatrick skin types I-VI
  5. Subjects are in good health as judged by the investigator.
  6. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.

Exclusion criteria:

  1. Subjects who by the investigator are not suitable for photodynamic therapy.
  2. Lesions suspicious or proven for skin cancer
  3. History of 2 or more ALA- PDT treatments within the past 6 months.
  4. Use of keratolytics within 2 days of initiation of treatment (e.g., >5% urea, glycolic acid, lactic acid, salicyclic acid)
  5. Cryotherapy within the past 2 weeks.
  6. Topical retinoids within the past 4 weeks
  7. Procedures, such as microdermabrasion, ablative lasers, ALA-PDT, chemical peels, 5-fluorouraci, diclofenac, imiquimod within the past 8 weeks
  8. Systemic retinoids within the past 6 months
  9. Pregnant or breast feeding
  10. Uncooperative subjects or subjects with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
  11. Subjects who are unable to understand the protocol or give informed consent.
  12. Subjects who in the opinion of the investigator are not suitable for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066843


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Murad Alam, MD Northwestern University

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Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT03066843     History of Changes
Other Study ID Numbers: STU00204459
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents