Actinic KeratosesNCT00756288
Photo-therapy With a Topical Retinoid Versus Photo-therapy Alone for Actinic Keratoses
A study testing Topical retinoid and blue-light therapy with photosensitizing agent and Photodynamic Therapy (PDT) in people with Actinic Keratoses, run by Northwestern University.
Trial summary
Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy for the treatment of actinic keratoses. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Topical retinoid and blue-light therapy with photosensitizing agent and Photodynamic Therapy (PDT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-80 years old
- Subjects with AK lesions who will receive PDT
- Subjects with AK lesions in two areas other than face and scalp each with a surface area of 10cm2 or greater and at least 3 clinically diagnosed non-hypertrophic AK lesions in each
- Subjects in good health
- Subjects with willingness and the ability to understand and provide informed consent
Who cannot join
- 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 who received previous treatment of target AKs within 4 weeks
- Subjects who are unable to understand the protocol or give informed consent
About this study
Official title: A Randomized Controlled Paired Comparison of Photo-therapy With a Topical Retinoid Cream Pretreatment Versus PDT Alone for Actinic Keratoses
Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy for the treatment of actinic keratoses.
Read the detailed description
Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy vs photodynamic therapy alone for the treatment of actinic keratoses.
- Conditions
- Actinic Keratoses
- Being tested
- Topical retinoid and blue-light therapy with photosensitizing agent, Photodynamic Therapy (PDT)
- Keywords
- Actinic Keratoses, Blue light therapy, photosensitizer, Retinoid
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical retinoid and blue-light therapy with photosensitizing agentProcedure or surgery
Topical Retinoid - Apply to AKs for 4 weeks Photo-therapy with photosensitizing agent- Apply to AKs at week 4
Photodynamic Therapy (PDT)Procedure or surgery
Photo-therapy with sensitizing agent - apply to AKs at week 4
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Topical retinoid and Light therapy with photosensitizing agent Receives: Procedure: Topical retinoid and blue-light therapy with photosensitizing agent |
| 2 | Active comparator | Light therapy with photosensitizing agent Receives: Procedure: Photodynamic Therapy (PDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live blinded rater and blinded photo rater analysis of areas at week 0 and week 6 for erythema, edema, crusting, ulceration, palpability, need to cease/delay treatment, and overall response in reduction of number of actinic keratoses (AKs).
Measured: 6 weeks
Secondary outcomes (1)
Subjects will assess pain, burning and itching on a scale of 0-3 at week 0, during retinoid treatment, during photo-therapy, one day after, and week 6. Also, principal investigator will evaluate adverse events at week 6.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startMar 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756288
- Sponsor's protocol ID
- STU2574
- Status last verified
- Dec 2021
- First submitted
- 19 Sep 2008
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Paired Comparison of Photo-therapy With a Topical Retinoid Cream Pretreatment Versus PDT Alone for Actinic Keratoses
- ClinicalTrials.gov ID
- NCT00756288
- Acronym / sponsor ID
- STU2574
- Conditions
- Actinic Keratoses
- Keywords
- Actinic Keratoses, Blue light therapy, photosensitizer, Retinoid
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 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.
Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy for the treatment of actinic keratoses.
Detailed description
Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy vs photodynamic therapy alone for the treatment of actinic keratoses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Topical retinoid and blue-light therapy with photosensitizing agentTopical retinoid and Light therapy with photosensitizing agent |
| 2 | Active comparator | Procedure: Photodynamic Therapy (PDT)Light therapy with photosensitizing agent |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-80 years old
- Subjects with AK lesions who will receive PDT
- Subjects with AK lesions in two areas other than face and scalp each with a surface area of 10cm2 or greater and at least 3 clinically diagnosed non-hypertrophic AK lesions in each
- Subjects in good health
- Subjects with willingness and the ability to understand and provide informed consent
Key exclusion criteria (6 listed)
- 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 who received previous treatment of target AKs within 4 weeks
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 |
|---|---|---|
| Topical retinoid and blue-light therapy with photosensitizing agentTopical Retinoid - Apply to AKs for 4 weeks Photo-therapy with photosensitizing agent- Apply to AKs at week 4 | Procedure or surgery | 1 |
| Photodynamic Therapy (PDT)Photo-therapy with sensitizing agent - apply to AKs at week 4 | Procedure or surgery | 2 |
Primary outcome
Live blinded rater and blinded photo rater analysis of areas at week 0 and week 6 for erythema, edema, crusting, ulceration, palpability, need to cease/delay treatment, and overall response in reduction of number of actinic keratoses (AKs).
Time frame: 6 weeks
1 secondary outcome
Subjects will assess pain, burning and itching on a scale of 0-3 at week 0, during retinoid treatment, during photo-therapy, one day after, and week 6. Also, principal investigator will evaluate adverse events at week 6.
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
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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.
Murad Alam, MD principal investigator
Northwestern University Department of Dermatology
Questions about this trial
What is this clinical trial studying?
A study testing Topical retinoid and blue-light therapy with photosensitizing agent and Photodynamic Therapy (PDT) in people with Actinic Keratoses, run by Northwestern University.
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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Live blinded rater and blinded photo rater analysis of areas at week 0 and week 6 for erythema, edema, crusting, ulceration, palpability, need to cease/delay treatment, and overall response in reduction of number of actinic keratoses (AKs). (time frame: 6 weeks). 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 6 Dec 2021.