A Photodynamic Therapy for Treatment of Actinic Keratoses
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to compare the efficacy of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light vs absence of treatment for actinic keratoses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 13, 2007
CompletedFirst Posted
Study publicly available on registry
November 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedDecember 6, 2021
December 1, 2021
2 years
November 13, 2007
December 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Visual assessment of lesions
4 weeks
Secondary Outcomes (1)
Patient subjective assessment and Safety
4 weeks
Study Arms (2)
1
EXPERIMENTALLight Therapy
2
EXPERIMENTALLight Therapy
Interventions
Eligibility Criteria
You may qualify if:
- Age greater than or equal to 18 years
- Have a t least 4 nonhypertrophic AK lesions on the body
- The subjects are in good health
- The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate to the investigator
You may not qualify if:
- Subjects who are pregnant or lactating
- Subjects with a history of cutaneous photosensitivity or porphyria, hypersensitivity to porphyrins, or photodermatosis
- Subjects with use of photosensitizing drugs within 1 week of study start
- Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry
- Subjects with systemic steroid therapy within 4 weeks before study entry
- Subjects who received previous treatment of target AKs
- Subjects with systemic treatment with chemotherapeutic agents, masoprocol (Actinex), immunotherapy, or retinoids within 2 months of study entry
- Subjects with prior history of hypersensitivity reactions to lidocaine
- Subjects who are unable to understand the protocol or to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University Department of Dermatology
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Murad Alam, MD
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery
Study Record Dates
First Submitted
November 13, 2007
First Posted
November 15, 2007
Study Start
August 1, 2007
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
December 6, 2021
Record last verified: 2021-12