Actinic Keratosis of Face and ScalpPhase 2NCT01921907
Evaluation of a Topical Treatment for Actinic Keratosis
A Phase 2 study testing AD17137 topical treatment in people with Actinic Keratosis of Face and Scalp, run by Assuta Hospital Systems at 1 site in Israel.
Trial summary
A topical treatment applied twice daily for 4 weeks to induce disappearance of facial actinic keratosis (AK). First 4 weeks treatment (visit 1, 2 and 3 at 0,2 an 4 weeks) treated as a double blind parallel study. From weeks 4 to 7 (visit 3 to visit 4) all patients to be treated by the active component. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Actinic Keratosis of Face and Scalp
- What is being tested?
- AD17137 topical treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2013to Jul 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females 30 to 90 years old, inclusive, in good general health
- Clinical diagnosis of Actinic Keratosis
- At least 2 clinically diagnosed, 3-15 mm AK lesions on face or scalp
- Patient is competent to understand and sign a consent form, and is willing and able to follow study procedures and attend all visits
- Female patients of childbearing potential must have a negative urine pregnancy test prior to receiving study medication
- Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception
- Pharmacologic methods of contraception should be stable for 1 month prior to Visit 1 and be maintained at same dose during the study
Who cannot join
- Patients who had been treated with: 5-FU, diclofenac, retinoids, ingenol mebutate or imiquimod within 4 weeks of study, immunomodulators, or interferon/interferon inducers or systemic immunosuppressants within 8 weeks of study, cryodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks of study, systemic cancer therapy, UVA therapy, UVB therapy, laser abrasion, dermabrasion
- History of hereditary angio-edema, Epilepsy or Parkinson's Disease
- Erythroderma or history of immunodeficiency disorders
- Pregnancy, lactation or patient who is not practicing effective contraception
- History of alcohol and drug abuse within 5 years of screening
- Known hypersensitivity or previous allergic reaction to any of the components of the study medication
Show all 9Show fewer
- Having a member of the same household in the trial
- Patient has participated in an investigational clinical, surgical, drug or device study within the past 30 days
- Patients who in the opinion of the investigator should not be included in the study for any reason, including inability to follow procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study
A topical treatment applied twice daily for 4 weeks to induce disappearance of facial actinic keratosis (AK). First 4 weeks treatment (visit 1, 2 and 3 at 0,2 an 4 weeks) treated as a double blind parallel study. From weeks 4 to 7 (visit 3 to visit 4) all patients to be treated by the active component.
- Conditions
- Actinic Keratosis of Face and Scalp
- Being tested
- AD17137 topical treatment, Placebo
- Keywords
- Actinic keratosis, topical, dermatology, treatment, clinical study, double blinded
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD17137 topical treatmentDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | topical treatment Receives: Drug: AD17137 topical treatment |
| Placebo | Placebo comparator | topical treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Clearance (100% of AK lesions) from baseline (Visit 1) to Visits 3 and 4. Complete Clearance (100% of AK lesions) from baseline (Visit 1) to Visits 3 and 4.
Measured: baseline to Week 7
Secondary outcomes (5)
Partial Clearance (75% of AK lesions) from baseline (Visit 1) to Visits 3 and 4.
Measured: baseline to Week 7
Mean change in lesion size
Measured: baseline to Week 7
Change in Investigator Global Assessment
Measured: baseline to Week 7
Mean change in lesion number
Measured: baseline to Week 7
Change in Patient Global Assessment
Measured: baseline to Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic Keratosis of Face and ScalpStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921907
- Sponsor's protocol ID
- AD17137
- Status last verified
- Feb 2015
- First submitted
- 31 Jul 2013
- Last updated
- 10 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study
- ClinicalTrials.gov ID
- NCT01921907
- Acronym / sponsor ID
- AD17137
- Conditions
- Actinic Keratosis of Face and Scalp
- Keywords
- Actinic keratosis, topical, dermatology, treatment, clinical study, double blinded
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 14 Aug 2013 (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.
A topical treatment applied twice daily for 4 weeks to induce disappearance of facial actinic keratosis (AK). First 4 weeks treatment (visit 1, 2 and 3 at 0,2 an 4 weeks) treated as a double blind parallel study. From weeks 4 to 7 (visit 3 to visit 4) all patients to be treated by the active component.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: AD17137 topical treatmenttopical treatment |
| Placebo | Placebo comparator | Drug: Placebotopical treatment |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females 30 to 90 years old, inclusive, in good general health
- Clinical diagnosis of Actinic Keratosis
- At least 2 clinically diagnosed, 3-15 mm AK lesions on face or scalp
- Patient is competent to understand and sign a consent form, and is willing and able to follow study procedures and attend all visits
- Female patients of childbearing potential must have a negative urine pregnancy test prior to receiving study medication
Key exclusion criteria (9 listed)
- Patients who had been treated with: 5-FU, diclofenac, retinoids, ingenol mebutate or imiquimod within 4 weeks of study, immunomodulators, or interferon/interferon inducers or systemic immunosuppressants within 8 weeks of study, cryodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks of study, systemic cancer therapy, UVA therapy, UVB therapy, laser abrasion, dermabrasion
- History of hereditary angio-edema, Epilepsy or Parkinson's Disease
- Erythroderma or history of immunodeficiency disorders
- Pregnancy, lactation or patient who is not practicing effective contraception
- History of alcohol and drug abuse within 5 years of screening
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 |
|---|---|---|
| AD17137 topical treatment | Drug | Active |
| Placebo | Drug | Placebo |
Primary outcome
Complete Clearance (100% of AK lesions) from baseline (Visit 1) to Visits 3 and 4. Complete Clearance (100% of AK lesions) from baseline (Visit 1) to Visits 3 and 4.
Time frame: baseline to Week 7
5 secondary outcomes
Partial Clearance (75% of AK lesions) from baseline (Visit 1) to Visits 3 and 4.
Time frame: baseline to Week 7
Mean change in lesion size
Time frame: baseline to Week 7
Change in Investigator Global Assessment
Time frame: baseline to Week 7
Mean change in lesion number
Time frame: baseline to Week 7
Change in Patient Global Assessment
Time frame: baseline to Week 7
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 10 Mar 2015.
Related trials for Actinic Keratosis of Face and Scalp
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
RecruitingPhase 3
Phase 3 - Evaluation of Veregen® 10% Ointment as New Herbal Topical Treatment for Actinic Keratosis
Actinic Keratosis of Face and Scalp
Active, not recruitingPhase 4
A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp
Keratosis, Actinic
Not yet recruiting
Efficacy of Topical 5-Fluorouracil Vs Calcipotriol As Photodynamic Therapy Pre-treatment for Field Actinic Keratoses
Actinic Keratosis of Face and Scalp, Actinic Keratoses
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 Phase 2 study testing AD17137 topical treatment in people with Actinic Keratosis of Face and Scalp, run by Assuta Hospital Systems at 1 site in Israel.
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 7 inclusion and 9 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 10 Mar 2015. 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 Israel. 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. Some participants in this study may receive a placebo. 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?
Complete Clearance (100% of AK lesions) from baseline (Visit 1) to Visits 3 and 4. Complete Clearance (100% of AK lesions) from baseline (Visit 1) to Visits 3 and 4. (time frame: baseline to Week 7). 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 Mar 2015.