Actinic KeratosisNCT01481155
Comparative Study of Photodynamic Therapy vs. CO2 Laser Therapy in Treatment of Actinic Keratoses
A study testing ablative CO2 laser therapy and photodynamic therapy in people with Actinic Keratosis, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether photodynamic therapy or CO2 laser therapy is superior in the treatment of actinic keratoses with respect to efficacy and side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- ablative CO2 laser therapy and photodynamic therapy
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Dec 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women with clinical and histological diagnosed, symmetrical distributed actinic keratoses
- at least 2 actinic keratoses, on each of both treatment areas at least one
- Patients must be 18 years or older.
Who cannot join
- Age 17 years or younger
- lack of patient's informed consent for any of the two treatments
- contraindication for Co2 therapy or for photodynamic therapy
- skin infection in the treatment area
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Dermatology, Venereology and Allergology, Ruhr University
Bochum, 44791
About this study
Official title: Prospective, Single-center, Investigator-blinded, Randomized, Half-side, Comparative Study of Photodynamic Therapy vs. CO2 Laser Therapy in Treatment of Actinic Keratoses
The purpose of this study is to determine whether photodynamic therapy or CO2 laser therapy is superior in the treatment of actinic keratoses with respect to efficacy and side effects.
Read the detailed description
Ablative laser therapy and photodynamic therapy are widely used and accepted therapeutic methods to treat multiple actinic keratoses, yet comparative studies are rare. The purpose of this study is to compare both treatments intraindividually with respect to treatment efficacy and side effects.
- Conditions
- Actinic Keratosis
- Being tested
- ablative CO2 laser therapy, photodynamic therapy
- Keywords
- actinic keratosis, field cancerisation
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ablative CO2 laser therapyProcedure or surgery
CO2 laser therapy
photodynamic therapyProcedure or surgery
Treatment with 5-ALA cream, application time at least 4 h, red light radiation with 76 J/cm²
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of actinic keratoses 3 months after treatment
Measured: 3 months
Secondary outcomes (2)
Histologic features
Measured: 1 month after therapy
Epidermal thickness in optical coherence tomography
Measured: 1 month after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nina Scola, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481155
- Sponsor's protocol ID
- PDT vs. CO2
- Status last verified
- Dec 2011
- First submitted
- 24 Nov 2011
- Last updated
- 8 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-center, Investigator-blinded, Randomized, Half-side, Comparative Study of Photodynamic Therapy vs. CO2 Laser Therapy in Treatment of Actinic Keratoses
- ClinicalTrials.gov ID
- NCT01481155
- Acronym / sponsor ID
- PDT vs. CO2
- Conditions
- Actinic Keratosis
- Keywords
- actinic keratosis, field cancerisation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (estimated)
- First posted
- 29 Nov 2011 (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.
The purpose of this study is to determine whether photodynamic therapy or CO2 laser therapy is superior in the treatment of actinic keratoses with respect to efficacy and side effects.
Detailed description
Ablative laser therapy and photodynamic therapy are widely used and accepted therapeutic methods to treat multiple actinic keratoses, yet comparative studies are rare. The purpose of this study is to compare both treatments intraindividually with respect to treatment efficacy and side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and women with clinical and histological diagnosed, symmetrical distributed actinic keratoses
- at least 2 actinic keratoses, on each of both treatment areas at least one
- Patients must be 18 years or older.
Key exclusion criteria (4 listed)
- Age 17 years or younger
- lack of patient's informed consent for any of the two treatments
- contraindication for Co2 therapy or for photodynamic therapy
- skin infection in the treatment area
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 |
|---|---|---|
| ablative CO2 laser therapyCO2 laser therapy | Procedure or surgery | – |
| photodynamic therapyTreatment with 5-ALA cream, application time at least 4 h, red light radiation with 76 J/cm² | Procedure or surgery | – |
Primary outcome
Number of actinic keratoses 3 months after treatment
Time frame: 3 months
2 secondary outcomes
Histologic features
Time frame: 1 month after therapy
Epidermal thickness in optical coherence tomography
Time frame: 1 month after therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ablative CO2 laser therapy and photodynamic therapy in people with Actinic Keratosis, run by Ruhr University of Bochum at 1 site in Germany.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Dec 2011. 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 Germany. 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.
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?
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?
Number of actinic keratoses 3 months after treatment (time frame: 3 months). 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 8 Dec 2011.