Actinic KeratosesNCT02451579
A Clinical Trial Evaluating the Role of Systemic Antihistamine Therapy in the Reduction of Adverse Effects Associated With Topical 5-aminolevulinic Acid Photodynamic Therapy
A study testing Antihistamine Cetirizine Hydrochloride in people with Actinic Keratoses, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Antihistamine Cetirizine Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- Having no uterus
- No menses for at least 12 months.
- Or;
- (WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as:
- Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
- Intrauterine coil
- Bilateral tubal ligation
- Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
- Abstinence (If practicing abstinence must agree to use barrier method described above (d) if becomes sexually active).
- Vasectomized partner g. Negative urine pregnancy test results Baseline prior to study entry (if applicable)
Who cannot join
- 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:
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- Oral diabetes medicines
- Griseofulvin
- Thiazide diuretics
- Sulfonylureas
- Phenothiazines
- Tetracycline's
- St. John's Wort
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cosmetic Laser Dermatology
San Diego, California, 92121
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Prospective Clinical Trial Evaluating the Role of Systemic Antihistamine Therapy in the Reduction of Adverse Effects Associated With Topical 5-aminolevulinic Acid Photodynamic Therapy
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.
- Conditions
- Actinic Keratoses
- Being tested
- Antihistamine Cetirizine Hydrochloride, Placebo
- Keywords
- Actinic Keratoses, Photodynamic Therapy, PDT, Blue Light
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antihistamine Cetirizine HydrochlorideDrug
Prophylactic use of antihistamine prior to and following topical 5-aminolevulonic acid photodynamic therapy
PlaceboOther
Use of placebo prior to and following topical 5-aminolevulonic acid photodynamic therapy
| Study group | Role | What they receive |
|---|---|---|
| Cetirizine Hydrochloride | Active comparator | Prophylactic use of cetirizine hydrochloride prior to and after Topical 5-aminolevulinic Acid Photodynamic Therapy Receives: Drug: Antihistamine Cetirizine Hydrochloride |
| Placebo | Placebo comparator | Prophylactic use of placebo prior to and after Topical 5-aminolevulinic Acid Photodynamic Therapy Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Localized Skin Response
Localized Skin Response consisting of erythema, edema, crusting, exudation, Vesiculation/Pustulation and erosion/ ulceration Investigator evaluated on a standardized scale
Measured: Up to day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- DUSA Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Mitchel P Goldman, MD, Principal investigator, Cosmetic Laser Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451579
- Sponsor's protocol ID
- PDT-2015-01
- Status last verified
- Feb 2017
- First submitted
- 12 May 2015
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28489298
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Prospective Clinical Trial Evaluating the Role of Systemic Antihistamine Therapy in the Reduction of Adverse Effects Associated With Topical 5-aminolevulinic Acid Photodynamic Therapy
- ClinicalTrials.gov ID
- NCT02451579
- Acronym / sponsor ID
- PDT-2015-01
- Conditions
- Actinic Keratoses
- Keywords
- Actinic Keratoses, Photodynamic Therapy, PDT, Blue Light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- DUSA Pharmaceuticals, Inc.
- Study start
- Feb 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cetirizine Hydrochloride | Active comparator | Drug: Antihistamine Cetirizine HydrochlorideProphylactic use of cetirizine hydrochloride prior to and after Topical 5-aminolevulinic Acid Photodynamic Therapy |
| Placebo | Placebo comparator | Other: PlaceboProphylactic use of placebo prior to and after Topical 5-aminolevulinic Acid Photodynamic Therapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antihistamine Cetirizine HydrochlorideProphylactic use of antihistamine prior to and following topical 5-aminolevulonic acid photodynamic therapy | Drug | Cetirizine Hydrochloride |
| PlaceboUse of placebo prior to and following topical 5-aminolevulonic acid photodynamic therapy | Other | Placebo |
Primary outcome
Localized Skin Response
Time frame: Up to day 180
Localized Skin Response consisting of erythema, edema, crusting, exudation, Vesiculation/Pustulation and erosion/ ulceration Investigator evaluated on a standardized scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Derived from this study: PubMed 28489298Vanaman 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchel P Goldman, MD principal investigator
Cosmetic Laser Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antihistamine Cetirizine Hydrochloride in people with Actinic Keratoses, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Localized Skin Response (time frame: Up to day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02451579, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.