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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00558688
Other study ID # STU00000312
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2007
Est. completion date August 2009

Study information

Verified date December 2021
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This study seeks to evaluate the efficacy of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light vs. absence of treatment for actinic keratoses


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Photodynamic therapy
Photodynamic therapy applied to actinic keratoses

Locations

Country Name City State
United States Northwestern University Department of Dermatology Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual assessment of lesions 4 weeks
Secondary Patient subjective assessment and Safety 4 weeks
See also
  Status Clinical Trial Phase
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Completed NCT04085367 - Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face Phase 3
Completed NCT05937529 - Impact of Madecassoside and 5 % Panthenol Cream in Post Photodynamic Therapy for Actinic Keratosis N/A
Completed NCT02520700 - A Comparison of White-light and Daylight Topical Methyl 5-aminolaevulinic Acid Photodynamic Therapy for Actinic Keratoses N/A
Terminated NCT01538901 - Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients Phase 4
Completed NCT01354717 - Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo Phase 3
Completed NCT00742391 - A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations Phase 3
Completed NCT03285477 - A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp Phase 3
Suspended NCT03963102 - Duration of Ameluz Application in Acral Actinic Keratoses Response Phase 4
Not yet recruiting NCT05923060 - Imaging Techniques to Monitor Photosensitizer and sO2 Levels During Photodynamic Therapy of Actinic Keratoses Phase 2
Withdrawn NCT06026358 - Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands Phase 4
Completed NCT02622594 - Bilateral Comparison of Treatment of Facial Actinic Keratoses Using Microneedling and Photodynamic Therapy With Aminolevulinic Acid and Blue Light Versus Photodynamic Therapy With Aminolevulinic Acid and Blue Light Using Two Incubation Times Phase 4
Completed NCT00786994 - The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses Phase 2
Completed NCT00774787 - Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses Phase 4
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Completed NCT04024579 - Treatment of Actinic Keratosis With 5% KOH Solution
Completed NCT04843553 - Nicotinamide for Prevention of Pre-malignant Actinic Keratosis in Kidney Transplant Recipients Early Phase 1
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Completed NCT03279328 - Evaluating Skin Appearance Following 5-Flourouracil Cream for Treatment of Actinic Keratosis and the Effects of Topical Agents Phase 4
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