Actinic KeratosisPhase 4NCT02990221
Efficacy of Ingenol Mebutate on Actinic Keratoses and Field Cancerization vs Cryotherapy
A Phase 4 study testing Ingenol mebutate and cryotherapy in people with Actinic Keratosis, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
The main objective of this study is to compare the effectiveness of ingenol mebutate gel (150 mcg / g per day, to be applied on a predetermined area of 25 cm2 of skin of the face or scalp, for 3 days consecutive) cryotherapy (application with 5 seconds of freezing time of each lesion located in a predetermined skin… 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?
- Ingenol mebutate and cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 12 Apr 2017to 30 Jul 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient will be enrolled if he/she meets all of the following inclusion criteria:
- Current diagnosis of AK, with ≥2 lesions of grade I and/or II located in two different anatomical districts (within a contiguous 25 cm2 area on the face, scalp or forehead);
- Male ≥ 18 years of age or Female > 60 years of age;
- Skin type I or II according to Fitzpatrick;
- Patient has confirmed his/her willingness to participate in this study after being informed of all aspects of the study that are relevant to his/her decision to participate, by signing and dating the approved informed consent form, according to ICH and local laws.
- The 25 cm2 contiguous treatment areas could be of any shape, e.g. 5 cm x 5 cm, 2 cm x 12.5 cm, 3 cm x 8.3 cm.
Who cannot join
- A patient will be excluded if he/she meets any of the following exclusion criteria:
- Has received any therapy for AK within the past 3 months
- Has AK of grade III
- Has currently a skin cancer or shows an early stage of skin cancer;
- Has another skin disease that requires treatment with other medications in the AK area or in distance of 3 cm;
- Use of cosmetic or therapeutic products and procedures which could interfere with assessments of the treatment area;
Show all 14Show fewer
- Immunosuppressive therapies or current treatment for cancer;
- Clinically unstable medical condition;
- High risk group for HIV infection or presentation of other infectious diseases (hepatitis A virus , hepatitis B virus , hepatitis C virus , Tuberculosis, etc);
- Allergies to the tested gel (ingenol mebutate and eccipients);
- Pregnancy and breastfeeding (see inclusion criteria);
- Psychiatric disease that may interfere with follow-up of study procedures;
- Participation in other clinical trials up to 30 days prior to day 1 of the study;
- Patient is, for any reason, considered by the investigator to be an unsuitable candidate for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study to Evaluate the Efficacy of Ingenol Mebutate on Actinic Keratoses and Field Cancerization Compared to Cryotherapy
The main objective of this study is to compare the effectiveness of ingenol mebutate gel (150 mcg / g per day, to be applied on a predetermined area of 25 cm2 of skin of the face or scalp, for 3 days consecutive) cryotherapy (application with 5 seconds of freezing time of each lesion located in a predetermined skin area of 25 cm2 of the face or scalp) in the treatment of actinic keratosis and their field cancerization.
Study details:
Read more
This study is randomized. 50 subjects with at least two actinic keratoses of grade I and II, located in two different districts of 25 cm2 skin of the face or scalp, and who meet all the inclusion criteria will be enrolled in the study by the investigators in the three different centers mentioned above.
The investigators will assess the effect of treatment by confocal microscopy and digital dermoscopy. The investigator will acquire images of selected areas of the face and scalp before and after treatment. Data will be collected and analyzed by the coordinating centre.
Procedure for the study:
Recruitment of subjects; random assignment of treatment (ingenol mebutate gel 150 micrograms/g and cryotherapy) to the two skin areas of 25 cm2 of the subject recruited; evaluation of the two areas with reflectance confocal microscopy and digital dermoscope. The measurements will be carried out at time 0, after 1 month and 6 months. The investigator must fill out a form for each subject at the beginning (day 0), after 1 month and at the end of the study (after 6 months). The subject must complete a questionnaire at the beginning (day 0), after 1 month and at the last follow-up visit (after 6 months).
Measurement parameters: Dermoscopy and confocal microscopy will be used to assess the percentage reduction in actinic keratoses and the damage of the cancerous area in the two selected areas treated with ingenol mebutate gel or cryotherapy, respectively.
Adverse / side events will be collected at each visit by the investigator and will be contained in another form.
Read the detailed description
This study is designed to compare the efficacy of topical ingenol mebutate (150 mcg/g once daily on a selected facial or scalp target area of 25 cm2, for 3 consecutive days) with cryosurgery (applied for a freeze time of 5 seconds, on each lesion included in an area of 25 cm2 on face or scalp)
This is a national, post-marketing (phase 4), on label, interventional, randomized trial.
Subjects will attend a screening visit where they will be assessed for eligibility.
Two areas of treatment in the same patient have to be identified (e.g. scalp and cheek or two different part of the balding scalp), than these two areas will be randomized in a 2:1 ratio: one will be treated with cryosurgery and the other one with Picato Gel.
The cryosurgery will be performed in the same day during the visit (1 application for a freeze time of 5 seconds, on each lesion included in an area of 25 cm2 on face or scalp) Picato gel 150 mcg will be applied at home by the patient, according to current indication (RCP: 3 consecutive days for a total of three application in an area of 25 cm2) Subjects will be followed for 24 weeks (about 6 months) after the cryosurgery application (Visit 1).
Adverse events and patient compliance will be recorded 7 days after cryosurgery application and 5 days after first Picato gel application (Visit 2). The number of AKs present within the treatment areas will be counted at Visit 1 (Baseline AK count) and at Visits 3 - 4 (AKcount). The data obtained will provide information on the effect of Picato gel versus Cryosurgery on recurrence rate of AKs.
Furthermore, the trial will also provide data on the effect of Picato gel versus Cryosurgery on the appearance rate of new AKs.
The final results for all subjects will be included in a Final Clinical Study Report in the original submission. This includes final results for all primary and secondary endpoints as well as 6-month recurrence and Adverse Event data.
- Conditions
- Actinic Keratosis
- Being tested
- Ingenol mebutate, cryotherapy
- Keywords
- Field Cancerization
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingenol mebutateDrug
Also called Picato
150 mcg / g per day, to be applied on a predetermined area of 25 cm2 of skin of the face or scalp, for 3 days consecutive
cryotherapyProcedure or surgery
Also called cryosurgery
application with 5 seconds of freezing time of each lesion located in a predetermined skin area of 25 cm2 of the face or scalp
| Study group | Role | What they receive |
|---|---|---|
| Ingenol mebutate | Active comparator | application of ingenol mebutate for 3 consecutive days on an area of face/scalp of 25 cm2 Receives: Drug: Ingenol mebutate |
| cryotherapy | Active comparator | application of criotherapy on actinic keratosis present in an area of face/scalp of 25 cm2 different from the ingenol mebutate area Receives: Procedure: cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
At least 75% reduction in the total AK count relative to baseline
The primary efficacy endpoint is the percentage change, at the end of the treatment period, in the number of AK lesions that were originally defined in the selected AK target area at baseline. The percentage change in the number of AK lesions is calculated as the number of lesions present at the end of the treatment period in the target area minus the number of AK lesions present in the target area at baseline visit divided by the number of lesions present in the target area at baseline. This variable will be analysed using a non-parametric analysis (Wilcoxon Rank-sum test).
Measured: 6-month follow-up
Reduction of subclinical AK lesions according to a Reflectance Confocal Microscopy score
Change from baseline in RCM score of target area and RCM score of cancerization field at the end of the treatment period. Each of the 13 RCM criteria will be scored 0 (absent), 1 (<25%), 2 (25%-50%), 3 (50-75%), or 4(>75%). An overall score will be obtained by averaging the RCM scores at the epidermal, DEJ and dermal level. The same approach will be used for the RCM examination of the cancerization field. The above variables will be compared between the groups using a t-test, 95% confidence interval for the between-group difference will be provided.
Measured: 6-month follow-up
Secondary outcomes (2)
Absence of new lesions after a follow-up period of 6 months
The count of AK lesions will be performed by exploration and palpation (numeric count) and the presence will be also confirmed by dermoscopic assessment (numeric count)
Measured: 6-month follow-up
cosmetic outcome
cosmetic outcome will be evaluated by Patient's assessment of satisfaction to product at the end of the treatment period (specific questionnaire)
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start12 Apr 2017
- Primary completion30 Apr 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Argenziano, University of Campania Luigi Vanvitelli
- Investigators
- Giuseppe Argenziano, Prof, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990221
- Sponsor's protocol ID
- IIS-PICATO 1264
- Status last verified
- Sep 2019
- First submitted
- 2 Dec 2016
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frost CA, Green AC. Epidemiology of solar keratoses. Br J Dermatol. 1994 Oct;131(4):455-64. doi: 10.1111/j.1365-2133.1994.tb08544.x.
PubMed 7947197Fu W, Cockerell CJ. The actinic (solar) keratosis: a 21st-century perspective. Arch Dermatol. 2003 Jan;139(1):66-70. doi: 10.1001/archderm.139.1.66. No abstract available.
PubMed 12533168Ortonne JP. From actinic keratosis to squamous cell carcinoma. Br J Dermatol. 2002 Apr;146 Suppl 61:20-3. doi: 10.1046/j.1365-2133.146.s61.6.x.
PubMed 11966728Cohen JL. Actinic keratosis treatment as a key component of preventive strategies for nonmelanoma skin cancer. J Clin Aesthet Dermatol. 2010 Jun;3(6):39-44.
PubMed 20725550Padilla RS, Sebastian S, Jiang Z, Nindl I, Larson R. Gene expression patterns of normal human skin, actinic keratosis, and squamous cell carcinoma: a spectrum of disease progression. Arch Dermatol. 2010 Mar;146(3):288-93. doi: 10.1001/archdermatol.2009.378.
PubMed 20231500Vatve M, Ortonne JP, Birch-Machin MA, Gupta G. Management of field change in actinic keratosis. Br J Dermatol. 2007 Dec;157 Suppl 2:21-4. doi: 10.1111/j.1365-2133.2007.08268.x.
PubMed 18067627Fidler B, Goldberg T. Ingenol mebutate gel (picato): a novel agent for the treatment of actinic keratoses. P T. 2014 Jan;39(1):40-6.
PubMed 24672213Andrews MD. Cryosurgery for common skin conditions. Am Fam Physician. 2004 May 15;69(10):2365-72.
PubMed 15168956
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Evaluate the Efficacy of Ingenol Mebutate on Actinic Keratoses and Field Cancerization Compared to Cryotherapy
- ClinicalTrials.gov ID
- NCT02990221
- Acronym / sponsor ID
- IIS-PICATO 1264
- Conditions
- Actinic Keratosis
- Keywords
- Field Cancerization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 13 Dec 2016 (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 main objective of this study is to compare the effectiveness of ingenol mebutate gel (150 mcg / g per day, to be applied on a predetermined area of 25 cm2 of skin of the face or scalp, for 3 days consecutive) cryotherapy (application with 5 seconds of freezing time of each lesion located in a predetermined skin area of 25 cm2 of the face or scalp) in the treatment of actinic keratosis and their field cancerization.
Study details:
This study is randomized. 50 subjects with at least two actinic keratoses of grade I and II, located in two different districts of 25 cm2 skin of the face or scalp, and who meet all the inclusion criteria will be enrolled in the study by the investigators in the three different centers mentioned above.
The investigators will assess the effect of treatment by confocal microscopy and digital dermoscopy. The investigator will acquire images of selected areas of the face and scalp before and after treatment. Data will be collected and analyzed by the coordinating centre.
Procedure for the study:
Recruitment of subjects; random assignment of treatment (ingenol mebutate gel 150 micrograms/g and cryotherapy) to the two skin areas of 25 cm2 of the subject recruited; evaluation of the two areas with reflectance confocal microscopy and digital dermoscope. The measurements will be carried out at time 0, after 1 month and 6 months. The investigator must fill out a form for each subject at the beginning (day 0), after 1 month and at the end of the study (after 6 months). The subject must complete a questionnaire at the beginning (day 0), after 1 month and at the last follow-up visit (after 6 months).
Measurement parameters: Dermoscopy and confocal microscopy will be used to assess the percentage reduction in actinic keratoses and the damage of the cancerous area in the two selected areas treated with ingenol mebutate gel or cryotherapy, respectively.
Adverse / side events will be collected at each visit by the investigator and will be contained in another form.
Detailed description
This study is designed to compare the efficacy of topical ingenol mebutate (150 mcg/g once daily on a selected facial or scalp target area of 25 cm2, for 3 consecutive days) with cryosurgery (applied for a freeze time of 5 seconds, on each lesion included in an area of 25 cm2 on face or scalp)
This is a national, post-marketing (phase 4), on label, interventional, randomized trial.
Subjects will attend a screening visit where they will be assessed for eligibility.
Two areas of treatment in the same patient have to be identified (e.g. scalp and cheek or two different part of the balding scalp), than these two areas will be randomized in a 2:1 ratio: one will be treated with cryosurgery and the other one with Picato Gel.
The cryosurgery will be performed in the same day during the visit (1 application for a freeze time of 5 seconds, on each lesion included in an area of 25 cm2 on face or scalp) Picato gel 150 mcg will be applied at home by the patient, according to current indication (RCP: 3 consecutive days for a total of three application in an area of 25 cm2) Subjects will be followed for 24 weeks (about 6 months) after the cryosurgery application (Visit 1).
Adverse events and patient compliance will be recorded 7 days after cryosurgery application and 5 days after first Picato gel application (Visit 2). The number of AKs present within the treatment areas will be counted at Visit 1 (Baseline AK count) and at Visits 3 - 4 (AKcount). The data obtained will provide information on the effect of Picato gel versus Cryosurgery on recurrence rate of AKs.
Furthermore, the trial will also provide data on the effect of Picato gel versus Cryosurgery on the appearance rate of new AKs.
The final results for all subjects will be included in a Final Clinical Study Report in the original submission. This includes final results for all primary and secondary endpoints as well as 6-month recurrence and Adverse Event data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ingenol mebutate | Active comparator | Drug: Ingenol mebutateapplication of ingenol mebutate for 3 consecutive days on an area of face/scalp of 25 cm2 |
| cryotherapy | Active comparator | Procedure: cryotherapyapplication of criotherapy on actinic keratosis present in an area of face/scalp of 25 cm2 different from the ingenol mebutate area |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Current diagnosis of AK, with ≥2 lesions of grade I and/or II located in two different anatomical districts (within a contiguous 25 cm2 area on the face, scalp or forehead);
- Male ≥ 18 years of age or Female > 60 years of age;
- Skin type I or II according to Fitzpatrick;
- Patient has confirmed his/her willingness to participate in this study after being informed of all aspects of the study that are relevant to his/her decision to participate, by signing and dating the approved informed consent form, according to ICH and local laws.
- The 25 cm2 contiguous treatment areas could be of any shape, e.g. 5 cm x 5 cm, 2 cm x 12.5 cm, 3 cm x 8.3 cm.
Key exclusion criteria (14 listed)
- Has received any therapy for AK within the past 3 months
- Has AK of grade III
- Has currently a skin cancer or shows an early stage of skin cancer;
- Has another skin disease that requires treatment with other medications in the AK area or in distance of 3 cm;
- Use of cosmetic or therapeutic products and procedures which could interfere with assessments of 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 |
|---|---|---|
| Ingenol mebutateAlso: Picato150 mcg / g per day, to be applied on a predetermined area of 25 cm2 of skin of the face or scalp, for 3 days consecutive | Drug | Ingenol mebutate |
| cryotherapyAlso: cryosurgeryapplication with 5 seconds of freezing time of each lesion located in a predetermined skin area of 25 cm2 of the face or scalp | Procedure or surgery | cryotherapy |
Primary outcome
At least 75% reduction in the total AK count relative to baseline
Time frame: 6-month follow-up
The primary efficacy endpoint is the percentage change, at the end of the treatment period, in the number of AK lesions that were originally defined in the selected AK target area at baseline. The percentage change in the number of AK lesions is calculated as the number of lesions present at the end of the treatment period in the target area minus the number of AK lesions present in the target area at baseline visit divided by the number of lesions present in the target area at baseline. This variable will be analysed using a non-parametric analysis (Wilcoxon Rank-sum test).
Reduction of subclinical AK lesions according to a Reflectance Confocal Microscopy score
Time frame: 6-month follow-up
Change from baseline in RCM score of target area and RCM score of cancerization field at the end of the treatment period. Each of the 13 RCM criteria will be scored 0 (absent), 1 (<25%), 2 (25%-50%), 3 (50-75%), or 4(>75%). An overall score will be obtained by averaging the RCM scores at the epidermal, DEJ and dermal level. The same approach will be used for the RCM examination of the cancerization field. The above variables will be compared between the groups using a t-test, 95% confidence interval for the between-group difference will be provided.
2 secondary outcomes
Absence of new lesions after a follow-up period of 6 months
Time frame: 6-month follow-up
cosmetic outcome
Time frame: 6-month follow-up
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 24 Sep 2019.
- Results publication: PubMed 7947197Frost CA, Green AC. Epidemiology of solar keratoses. Br J Dermatol. 1994 Oct;131(4):455-64. doi: 10.1111/j.1365-2133.1994.tb08544.x.
- Results publication: PubMed 12533168Fu W, Cockerell CJ. The actinic (solar) keratosis: a 21st-century perspective. Arch Dermatol. 2003 Jan;139(1):66-70. doi: 10.1001/archderm.139.1.66. No abstract available.
- Results publication: PubMed 11966728Ortonne JP. From actinic keratosis to squamous cell carcinoma. Br J Dermatol. 2002 Apr;146 Suppl 61:20-3. doi: 10.1046/j.1365-2133.146.s61.6.x.
- Results publication: PubMed 20725550Cohen JL. Actinic keratosis treatment as a key component of preventive strategies for nonmelanoma skin cancer. J Clin Aesthet Dermatol. 2010 Jun;3(6):39-44.
- Results publication: PubMed 20231500Padilla RS, Sebastian S, Jiang Z, Nindl I, Larson R. Gene expression patterns of normal human skin, actinic keratosis, and squamous cell carcinoma: a spectrum of disease progression. Arch Dermatol. 2010 Mar;146(3):288-93. doi: 10.1001/archdermatol.2009.378.
- Results publication: PubMed 18067627Vatve M, Ortonne JP, Birch-Machin MA, Gupta G. Management of field change in actinic keratosis. Br J Dermatol. 2007 Dec;157 Suppl 2:21-4. doi: 10.1111/j.1365-2133.2007.08268.x.
- Results publication: PubMed 24672213Fidler B, Goldberg T. Ingenol mebutate gel (picato): a novel agent for the treatment of actinic keratoses. P T. 2014 Jan;39(1):40-6.
- Results publication: PubMed 15168956Andrews MD. Cryosurgery for common skin conditions. Am Fam Physician. 2004 May 15;69(10):2365-72.
- Individual participant dataSharing planned: No
Related trials for Actinic Keratosis
Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
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.
Giuseppe Argenziano, Prof principal investigator
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ingenol mebutate and cryotherapy in people with Actinic Keratosis, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 6 inclusion and 14 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 24 Sep 2019. 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 Italy. 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?
At least 75% reduction in the total AK count relative to baseline (time frame: 6-month follow-up). The study lists 2 primary outcomes in all. 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 NCT02990221, which also lists 8 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 24 Sep 2019.