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| Name | Class |
|---|---|
| DUSA Pharmaceuticals, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetirizine Hydrochloride | Active Comparator | Prophylactic use of cetirizine hydrochloride prior to and after Topical 5-aminolevulinic Acid Photodynamic Therapy |
|
| Placebo | Placebo Comparator | Prophylactic use of placebo prior to and after Topical 5-aminolevulinic Acid Photodynamic Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antihistamine Cetirizine Hydrochloride | Drug | Prophylactic use of antihistamine prior to and following topical 5-aminolevulonic acid photodynamic therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Localized Skin Response | Localized Skin Response consisting of erythema, edema, crusting, exudation, Vesiculation/Pustulation and erosion/ ulceration Investigator evaluated on a standardized scale | Up to day 180 |
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Inclusion Criteria:
Age > 18
Subjects with 5-20 actinic keratosis of the face
Patients undergoing photodynamic therapy (PDT) to the face for AK with 5-aminolevulinic acid (ALA) activated by blue light.
Must be willing to give and sign a HIPPA form, photo consent and informed consent form.
Must be willing to comply with study dosing and complete the entire course of the study.
Female patients will be either of non-childbearing potential defined as:
Or;
(WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as:
Exclusion Criteria:
Presence of incompletely healed wound in treatment area
Presence of known or suspected BCC or SCC in treatment area
Previous PDT or treatment of the face with any topical cytotoxic or immunomodulatory agent for AKs within the past 6 months
Co-existing potentially confounding skin condition within treatment area (e.g. eczema, psoriasis, XP, rosacea) at investigator's discretion
Presence of tattoo and/or scar in the treatment area that in the investigators opinion would interfere with study assessments
Subjects with known photosensitivity or taking photosensitizing medications listed below:
Use of oral/topical retinoids within 1 month of Baseline
Subjects with a history of sensitivity to porphyrins
Subjects with recently excessive exposure of the treatment area to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study
Female subjects who are pregnant, nursing an infant or planning a pregnancy during the study [throughout the course of the study
Presence or evidence of any conditions that in the opinion of the investigator might impede the subject's ability to give consent or comply with protocol requirements.
Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
History of non-compliance with clinical research protocols
Ablative laser resurfacing to on their face within 12 months
Non-ablative laser or light procedures to their face within the past 3 months
Microdermabrasion (light or medium skin peel) treatment on their face within the past 30 days](streamdown:incomplete-link)
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| Name | Affiliation | Role |
|---|---|---|
| Mitchel P Goldman, MD | Cosmetic Laser Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cosmetic Laser Dermatology | San Diego | California | 92121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28489298 | Derived | Vanaman Wilson MJ, Jones IT, Wu DC, Goldman MP. A randomized, double-blind, placebo-controlled clinical trial evaluating the role of systemic antihistamine therapy for the reduction of adverse effects associated with topical 5-aminolevulinic acid photodynamic therapy. Lasers Surg Med. 2017 Oct;49(8):738-742. doi: 10.1002/lsm.22682. Epub 2017 May 10. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 1, 2019 | |
| Reset | May 22, 2019 | |
| Release | Aug 15, 2019 |
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| Placebo | Other | Use of placebo prior to and following topical 5-aminolevulonic acid photodynamic therapy |
|
| Reset | Sep 4, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 1, 2019 | May 22, 2019 | |||
| Aug 15, 2019 | Sep 4, 2019 |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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