Non-melanomatous Skin CancerPhase 2NCT00747903
Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer
A Phase 2 study testing aminolevulinic acid hydrochloride in people with Non-melanomatous Skin Cancer, run by Laser and Skin Surgery Center of New York at 1 site in United States.
Trial summary
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment against skin cancer. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Non-melanomatous Skin Cancer
- What is being tested?
- aminolevulinic acid hydrochloride
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Dec 2010
- Phase
- Phase 2
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Biopsy-proven basal cell carcinoma on the trunk or extremities
- Tumor size ≤ 2 cm in diameter
PATIENT CHARACTERISTICS:
- Willing and able to comply with all follow-up requirements
- Mentally competent
- No active, localized, or systemic infections
- Not immunocompromised
- No coagulation disorder
- No photosensitivity or allergy to sunlight
- Not pregnant or nursing
- No history of keloid formation
- No history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins, or photodermatosis
PRIOR CONCURRENT THERAPY:
- No prior gold therapy
- No prior radiotherapy to the trunk and extremities
- More than 24 months since prior oral retinoids (e.g., isotretinoin or acitretin) or photosensitizing drugs (e.g., Declomycin®)
- More than 1 year since prior collagen or other injections, Botox® injections, chemical peels, dermabrasion, or resurfacing procedures
- More than 1 month since prior topical retinoid therapy
- No concurrent aspirin or antioxidants
- No concurrent anticoagulation medications
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Laser and Skin Surgery Center of New York
New York, New York, 10016
Roy G. Geronemus, MD, 212-686-7306, mail@laserskinsurgery.com
About this study
Official title: Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment against skin cancer.
PURPOSE: This phase II trial is studying the side effects of photodynamic therapy using aminolevulinic acid and to see how well it works in treating patients with skin cancer.
Read the detailed description
OBJECTIVES:
- To determine the safety and efficacy of intralesional photodynamic therapy using aminolevulinic acid and non-coherent blue light in patients with nodular basal cell carcinoma.
OUTLINE: Patients undergo photodynamic therapy comprising intralesional injection of aminolevulinic acid followed by non-coherent blue light therapy over approximately 17 minutes. Patients may undergo re-treatment with photodynamic therapy 8 weeks later.
Patients undergo photographic assessment of their skin lesions at baseline, 8 weeks, 16 weeks, and then at 1 and 2 years to evaluate healing time, clinical improvement, and side effects.
Patients undergo biopsies of their skin lesions at 16 weeks and then at 1 and 2 years to confirm histological clearance.
- Conditions
- Non-melanomatous Skin Cancer
- Being tested
- aminolevulinic acid hydrochloride
- Keywords
- basal cell carcinoma of the skin, recurrent skin cancer
- Medical subject headings
- Carcinoma, Basal Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aminolevulinic acid hydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-melanomatous Skin CancerStudies 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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laser and Skin Surgery Center of New York
- Sponsor type
- University, hospital or other
- Investigators
- Diana Santanello, Laser and Skin Surgery Center of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747903
- Sponsor's protocol ID
- CDR0000613601
- Other IDs
- DUSA-PDT-BCC-06
- Status last verified
- Jul 2009
- First submitted
- 5 Sep 2008
- Last updated
- 10 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00747903
- Acronym / sponsor ID
- CDR0000613601
- Conditions
- Non-melanomatous Skin Cancer
- Keywords
- basal cell carcinoma of the skin, recurrent skin cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Laser and Skin Surgery Center of New YorkUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2010 (estimated)
- First posted
- 8 Sep 2008 (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.
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment against skin cancer.
PURPOSE: This phase II trial is studying the side effects of photodynamic therapy using aminolevulinic acid and to see how well it works in treating patients with skin cancer.
Detailed description
OBJECTIVES:
- To determine the safety and efficacy of intralesional photodynamic therapy using aminolevulinic acid and non-coherent blue light in patients with nodular basal cell carcinoma.
OUTLINE: Patients undergo photodynamic therapy comprising intralesional injection of aminolevulinic acid followed by non-coherent blue light therapy over approximately 17 minutes. Patients may undergo re-treatment with photodynamic therapy 8 weeks later.
Patients undergo photographic assessment of their skin lesions at baseline, 8 weeks, 16 weeks, and then at 1 and 2 years to evaluate healing time, clinical improvement, and side effects.
Patients undergo biopsies of their skin lesions at 16 weeks and then at 1 and 2 years to confirm histological clearance.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| aminolevulinic acid hydrochloride | Drug | – |
Primary outcome
Safety
Efficacy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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.
Laser and Skin Surgery Center of New York
New York, United States
Diana Santanello
Laser and Skin Surgery Center of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aminolevulinic acid hydrochloride in people with Non-melanomatous Skin Cancer, run by Laser and Skin Surgery Center of New York 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?
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: status not confirmed, as of the sponsor's last update on 10 Jan 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2014.