Actinic Keratosis Olsen Grade I/IIPhase 2NCT01757613
Study Whose Purpose is to Find an Optimal Dose for the Treatment With AK 3012 in Patients With Actinic Keratosis
A Phase 2 study testing AK 3012 in people with Actinic Keratosis Olsen Grade I/II, run by Dolorgiet GmbH & Co. KG at 9 sites in Germany.
Trial summary
In this three-armed dose-finding trial 3 AK 3012 topical formulations shall be investigated with respect to safety and efficacy in order to identify the optimal concentration in the topical formulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis Olsen Grade I/II
- What is being tested?
- AK 3012
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 9 sitesGermany
- Study dates
- Dec 2012to Jan 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥ 18 years
- Gender: male and female
- Actinic Keratosis (Olsen grade I/II)
- at least 5 actinic keratoses on the scalp, forehead, face, extremities, and/ or decollete
- no treatment of the actinic keratoses within the previous 3 months before inclusion in the study
- histologic confirmation of the diagnosis actinic keratosis by biopsy
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- good general condition
- normal laboratory values (creatinine, urea, Glutamate-Oxalacetate Transaminase (GOT),Glutamate-Pyruvate Transaminase (GPT), gamma-glutamyl transferase (GGT), Lactate dehydrogenase (LDH)) and blood count at study start not higher than 1.5 x upper norm limit
- Female patients must be tested negative for pregnancy before inclusion in the trial. During the trial, female patients have to apply a generally accepted form of birth control (i.e. oral estrogen- and gestagen containing contraceptives; estrogen containing skin plaster/ tape, hormone implant, hormone contraceptive coil, sterilisation; sexual abstinence) or being post-menopausal for at least 2 years.
- Willing and able to participate in the screening and all trial specific procedures in compliance with the protocol
- Signed written informed consent
Who cannot join
- Known allergy against nonsteroidal antiphlogistics and/ or against excipients of the investigational medicinal product
- Presence of immunosuppression
- Treatment with 5-fluorouracil, cyclosporine, retinoids, glycolic acid, imiquimod, trichloroacetic acid during the trial or 12 weeks before inclusion in the trial
- Continuous treatment with nonsteroidal antiphlogistics with the exception of low-dose acetylsalicylic acid (100 mg) for inhibition of thrombocyte aggregation
- Planned treatment with photodynamic therapy during participation in the trial
- Pregnancy or lactation
- Participation in another clinical trial within 3 months before inclusion in the current trial
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Study site
Blaubeuren Abbey, 89143
Study site
Friedrichshafen, 88045
Study site
Hamburg, 22391
Study site
Langenau, 89129
Study site
Radolfzell, 78315
Study site
Stuttgart, 70178
Study site
Stuttgart, 70190
Study site
Stuttgart, 70499
Study site
Tübingen, 72076
About this study
Official title: Three-armed, Randomized, Double-blind Dose-finding Trial on Efficiency and Safety of AK 3012 in 3 Different Concentrations in Patients With Actinic Keratosis Olsen Grade I/II
In this three-armed dose-finding trial 3 AK 3012 topical formulations shall be investigated with respect to safety and efficacy in order to identify the optimal concentration in the topical formulation.
The main objective of the trial is to determine the optimal concentration of the active agent in the topical formulation as quantified by the change of the number of skin alterations in pre-defined areas in a time period from inclusion in the trial until the end of treatment (3 months) or prior complete healing.
- Conditions
- Actinic Keratosis Olsen Grade I/II
- Being tested
- AK 3012
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK 3012Drug
cutaneous use twice a day
| Study group | Role | What they receive |
|---|---|---|
| AK 3012 a for topical use | Active comparator | Not described Receives: Drug: AK 3012 |
| AK 3012 b for topical use | Active comparator | Not described Receives: Drug: AK 3012 |
| AK 3012 c for topical use | Active comparator | Not described Receives: Drug: AK 3012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of skin alterations during treatment period
Measured: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90)
Secondary outcomes (3)
Change of visible skin alterations during treatment period
Measured: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90)
Tolerability of the investigated medicinal product
Tolerability will be assessed on the basis of adverse events
Measured: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90)
Adverse events
Measured: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic Keratosis Olsen Grade I/IIStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dolorgiet GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CenTrial GmbH, d.s.h. statistical services GmbH
- Responsible party
- Sponsor
- Investigators
- Amir Yazdi, Dr. med, Principal investigator, Eberhard-Karls-Universität TübingenAngelika Trapp, Study director, Dolorgiet GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757613
- Sponsor's protocol ID
- KER-001
- Other IDs
- 2012-002529-30
- Status last verified
- May 2014
- First submitted
- 18 Dec 2012
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-armed, Randomized, Double-blind Dose-finding Trial on Efficiency and Safety of AK 3012 in 3 Different Concentrations in Patients With Actinic Keratosis Olsen Grade I/II
- ClinicalTrials.gov ID
- NCT01757613
- Acronym / sponsor ID
- KER-001
- Conditions
- Actinic Keratosis Olsen Grade I/II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Dolorgiet GmbH & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- CenTrial GmbH, d.s.h. statistical services GmbH
- Study start
- Dec 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 31 Dec 2012 (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.
In this three-armed dose-finding trial 3 AK 3012 topical formulations shall be investigated with respect to safety and efficacy in order to identify the optimal concentration in the topical formulation.
The main objective of the trial is to determine the optimal concentration of the active agent in the topical formulation as quantified by the change of the number of skin alterations in pre-defined areas in a time period from inclusion in the trial until the end of treatment (3 months) or prior complete healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AK 3012 a for topical use | Active comparator | Drug: AK 3012 |
| AK 3012 b for topical use | Active comparator | Drug: AK 3012 |
| AK 3012 c for topical use | Active comparator | Drug: AK 3012 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: ≥ 18 years
- Gender: male and female
- Actinic Keratosis (Olsen grade I/II)
- at least 5 actinic keratoses on the scalp, forehead, face, extremities, and/ or decollete
- no treatment of the actinic keratoses within the previous 3 months before inclusion in the study
Key exclusion criteria (7 listed)
- Known allergy against nonsteroidal antiphlogistics and/ or against excipients of the investigational medicinal product
- Presence of immunosuppression
- Treatment with 5-fluorouracil, cyclosporine, retinoids, glycolic acid, imiquimod, trichloroacetic acid during the trial or 12 weeks before inclusion in the trial
- Continuous treatment with nonsteroidal antiphlogistics with the exception of low-dose acetylsalicylic acid (100 mg) for inhibition of thrombocyte aggregation
- Planned treatment with photodynamic therapy during participation in the trial
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 |
|---|---|---|
| AK 3012cutaneous use twice a day | Drug | AK 3012 a for topical use, AK 3012 b for topical use, AK 3012 c for topical use |
Primary outcome
Change of skin alterations during treatment period
Time frame: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90)
3 secondary outcomes
Change of visible skin alterations during treatment period
Time frame: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90)
Tolerability of the investigated medicinal product
Time frame: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90)
Adverse events
Time frame: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90)
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 14 May 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.
Amir Yazdi, Dr. med principal investigator
Eberhard-Karls-Universität Tübingen
Angelika Trapp study director
Dolorgiet GmbH & Co. KG
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK 3012 in people with Actinic Keratosis Olsen Grade I/II, run by Dolorgiet GmbH & Co. KG at 9 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 11 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 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 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?
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?
Change of skin alterations during treatment period (time frame: 90 days: Between Visit 0 (day 0) and Visit 3 (day 90)). 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 14 May 2014.