Photosensitivity DisordersPhase 4NCT00204542
Comparison of the Efficacy and Tolerability of Solaraze for 3 Versus 6 Months in Patients With Mild to Moderate Actinic Keratosis Located on the Face and Head
A Phase 4 study testing Diclofenac in people with Photosensitivity Disorders, run by University Hospital Tuebingen at 4 sites in Germany.
Trial summary
Topical treatment of mild to moderate actinic keratosis located on the face and head with Solaraze® is known to be a safe and efficient treatment option. However, it is unclear if an expansion of the treatment period to 6 months will increase the rate of complete responses. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Photosensitivity Disorders
- What is being tested?
- Diclofenac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 4 sitesGermany
- Study dates
- Jun 2005to Dec 2010
- Phase
- Phase 4
- 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
- Visible and histologically proven actinic keratosis
- Prepared and able to give written informed consent
- ≥ 18 -80 years of age
- Prepared and comply with all study requirements, including the following: application of gel on the treatment area twice a day, 5 / 7 clinic visits during the prestudy, treatment, posttreatment, and follow-up period
- Pre- and posttreatment biopsy for histological confirmation (of clearance) of actinic keratosis diagnosis
Who cannot join
- Data of clinically significant, unstable, cardiovascular or haematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or diseases
- Known allergies to any excipient in the study drug
- Any dermatological disease and/or condition in the treatment or surrounding area (3 cm distances from treatment area) that may be exacerbated by treatment with diclofenac or cause difficulty with examination
- Active chemical dependency or alcoholism, as assessed by the investigator
- Currently participating in another clinical study or have completed another clinical study with an investigational drug within the past 30 days
- Received topical treatment at the treatment area with imiquimod or 5-FU within a time period of 1 month
- Invasive tumours within the treatment area, e.g. merkel cell carcinoma, squamous cell carcinoma, basal cell carcinoma, the latter is accepted if completely surgically removed
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Klinik fuer Dermatologie, Venerologie und Allergologie der Charite
Berlin, 10117
Dept. of Dermatology
Freiburg im Breisgau, 79104
Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8
Tübingen, Baden-Wurttemberg, 72076
Praxis Priv.-Doz. Dr. med. Dirschka
Wuppertal
About this study
Official title: Comparison of the Efficacy and Tolerability of Solaraze for 3 vs. 6 Months in Patients With Mild to Moderate Actinic Keratosis Located at the Face and Head
Topical treatment of mild to moderate actinic keratosis located on the face and head with Solaraze® is known to be a safe and efficient treatment option. However, it is unclear if an expansion of the treatment period to 6 months will increase the rate of complete responses.
Therefore the investigators will evaluate the efficacy and safety of the treatment of actinic keratosis with Solaraze® applied twice daily to the face and head over 3 or 6 months of treatment.
- Conditions
- Photosensitivity Disorders
- Being tested
- Diclofenac
- Keywords
- actinic keratosis, diclofenac sodium
- Medical subject headings
- Photosensitivity Disorders, Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
Solaraze® (Diclofenac sodium) 2x/day topical for 3 months
DiclofenacDrug
Solaraze® (Diclofenac sodium) 2x/day topical for 6 months
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Solaraze(R) 2x/day for 3 months Receives: Drug: Diclofenac |
| B | Active comparator | Solaraze(R) 2x/day for 6 months Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologically controlled complete clearance of the actinic keratosis
Measured: 6 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionMar 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Photosensitivity DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Claus Garbe, MD, Principal investigator, Skin Cancer Program, Department of Dermatology, University Hospital Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204542
- Sponsor's protocol ID
- ADO-Solaraze-AK-3-6
- Other IDs
- Eudra-CT-Nr. 2004-002761-21
- Status last verified
- Mar 2009
- First submitted
- 13 Sep 2005
- Last updated
- 19 Aug 2011
- Results posted
- No
Publications
Nelson C, Rigel D, Smith S, Swanson N, Wolf J. Phase IV, open-label assessment of the treatment of actinic keratosis with 3.0% diclofenac sodium topical gel (Solaraze). J Drugs Dermatol. 2004 Jul-Aug;3(4):401-7.
PubMed 15303784Rivers JK. Topical 3% diclofenac in 2.5% hyaluronan gel for the treatment of actinic keratoses. Skin Therapy Lett. 2004 Jan;9(1):1-3.
PubMed 14716439
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Tolerability of Solaraze for 3 vs. 6 Months in Patients With Mild to Moderate Actinic Keratosis Located at the Face and Head
- ClinicalTrials.gov ID
- NCT00204542
- Acronym / sponsor ID
- ADO-Solaraze-AK-3-6
- Conditions
- Photosensitivity Disorders
- Keywords
- actinic keratosis, diclofenac sodium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Sep 2005 (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.
Topical treatment of mild to moderate actinic keratosis located on the face and head with Solaraze® is known to be a safe and efficient treatment option. However, it is unclear if an expansion of the treatment period to 6 months will increase the rate of complete responses.
Therefore the investigators will evaluate the efficacy and safety of the treatment of actinic keratosis with Solaraze® applied twice daily to the face and head over 3 or 6 months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: DiclofenacSolaraze(R) 2x/day for 3 months |
| B | Active comparator | Drug: DiclofenacSolaraze(R) 2x/day for 6 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Visible and histologically proven actinic keratosis
- Prepared and able to give written informed consent
- ≥ 18 -80 years of age
- Prepared and comply with all study requirements, including the following: application of gel on the treatment area twice a day, 5 / 7 clinic visits during the prestudy, treatment, posttreatment, and follow-up period
- Pre- and posttreatment biopsy for histological confirmation (of clearance) of actinic keratosis diagnosis
Key exclusion criteria (7 listed)
- Data of clinically significant, unstable, cardiovascular or haematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or diseases
- Known allergies to any excipient in the study drug
- Any dermatological disease and/or condition in the treatment or surrounding area (3 cm distances from treatment area) that may be exacerbated by treatment with diclofenac or cause difficulty with examination
- Active chemical dependency or alcoholism, as assessed by the investigator
- Currently participating in another clinical study or have completed another clinical study with an investigational drug within the past 30 days
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 |
|---|---|---|
| DiclofenacSolaraze® (Diclofenac sodium) 2x/day topical for 3 months | Drug | A |
| DiclofenacSolaraze® (Diclofenac sodium) 2x/day topical for 6 months | Drug | B |
Primary outcome
Histologically controlled complete clearance of the actinic keratosis
Time frame: 6 weeks after end of treatment
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 19 Aug 2011.
- Background: PubMed 15303784Nelson C, Rigel D, Smith S, Swanson N, Wolf J. Phase IV, open-label assessment of the treatment of actinic keratosis with 3.0% diclofenac sodium topical gel (Solaraze). J Drugs Dermatol. 2004 Jul-Aug;3(4):401-7.
- Background: PubMed 14716439Rivers JK. Topical 3% diclofenac in 2.5% hyaluronan gel for the treatment of actinic keratoses. Skin Therapy Lett. 2004 Jan;9(1):1-3.
- Link to published abstractLink provided by the sponsor.
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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.
Claus Garbe, MD principal investigator
Skin Cancer Program, Department of Dermatology, University Hospital Tübingen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac in people with Photosensitivity Disorders, run by University Hospital Tuebingen at 4 sites 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 5 inclusion and 7 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 19 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Histologically controlled complete clearance of the actinic keratosis (time frame: 6 weeks after end of treatment). 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 NCT00204542, which also lists 2 linked publications.
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 19 Aug 2011.