Actinic KeratosisPhase 4NCT01656226
Long Term Efficacy and Safety of Eryfotona AK-NMSC® in Patients With Actinic Keratosis
A Phase 4 study testing Eryfotona AK-NMSC® cream and Sunscreen SPF 50+ in people with Actinic Keratosis, run by ISDIN at 1 site in Italy.
Trial summary
The purpose of this study is to assess the efficacy, safety and tolerability of Eryfotona AK-NMSC® topical application vs Sunscreen on cancerization field of actinic keratosis patients after 6 months of treatment. 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?
- Eryfotona AK-NMSC® cream and Sunscreen SPF 50+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2012to Jan 2014
- 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
- Current diagnosis of AK, with ≥4 lesions located in the same anatomical district (within a contiguous 50 cm2 area on the face, bold scalp or forehead);
- Female or male >18 years of age;
- Skin type I or II according to Fitzpatrick;
- Patient has confirmed his/her willingness to participate in this study;.
Who cannot join
- Topical drug therapy for AK within the past 3 months or for photoaging in the last 6 months, or had lesion-directed therapy within 2 cm2 of the selected AK area during the previous month;
- Suitable for surgical, photodynamic or any other topical treatment in the next 6 months;
- Subjects who suffer/ had suffered from skin cancer or show an early stage of skin cancer or have a genetic predisposition for skin cancer;
- Other skin disease that requires treatment with other medications in the treatment area or in the distance of 3 cm;
- Immunosuppression or current treatment for cancer;
- Clinically unstable medical condition;
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- High risk group for HIV infection or presentation of other infectious diseases
- Presentation of contact allergies or allergies to compounds of the test substances;
- Smoker (more than forty cigarettes per day) or heavy drinker (more than three standard drinks per day);
- 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
- Prior treatment with study medication in the area to be treated;
- Considered by the investigator, for any other reason, to be an unsuitable candidate for the study.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dermatology Unit, Medical Department Arcispedale Santa Maria Nuova
Reggio Emilia
About this study
Official title: A Randomised Double-blind Parallel-group Study to Evaluate the Long-term Effects of Eryfotona AK-NMSC® Cream in the Treatment of Cancerization Field in Patients With Actinic Keratosis.
The purpose of this study is to assess the efficacy, safety and tolerability of Eryfotona AK-NMSC® topical application vs Sunscreen on cancerization field of actinic keratosis patients after 6 months of treatment.
- Conditions
- Actinic Keratosis
- Being tested
- Eryfotona AK-NMSC® cream, Sunscreen SPF 50+
- Keywords
- Actinic Keratosis, AK
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eryfotona AK-NMSC® creamDevice
Cream, to be applied according to COLIPA standard at 2 mg/cm² in head and neck, twice a day before exposing to sun light morning and around lunchtime (about 4-6 hours later), for up to 6 months.
Sunscreen SPF 50+Other
Cream, to be applied according to COLIPA standard at 2 mg/cm² in head and neck, twice a day before exposing to sun light morning and around lunchtime (about 4-6 hours later), for up to 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Eryfotona AK-NMSC® cream | Experimental | Not described Receives: Device: Eryfotona AK-NMSC® cream |
| Sunscreen SPF 50+ | Other | Not described Receives: Other: Sunscreen SPF 50+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with partial clearance of AK lesions
Comparison between treatment groups at the end of the treatment period
Measured: 6 months
Secondary outcomes (11)
Percentage of patients with clearance and improvement of AK lesions
Comparison between treatment groups at the end of the treatment period
Measured: 6 months
Total number of AK lesions in the treated area (including all lesions present at baseline as well as subclinical lesions which appeared during therapy)
Comparison between treatment groups at the end of the treatment period
Measured: 6 months
Percentage of patients with improvement (clinical and dermoscopic assessment) of the target area as for the erythema, scaling, pigmentation and follicular plugs
Comparison between treatment groups at the end of the treatment period
Measured: 6 months
Percentage of patients with changes in the Investigator Global Improvement Index
Comparison between treatment groups at the end of the treatment period
Measured: 6 months
Percentage of patients with changes in Baseline Severity Index (BSI)
Comparison between treatment groups at the end of the treatment period
Measured: 6 months
Percentage of patients with improvement in the target AK lesion by using RCM score.
Comparison between treatment groups at the end of the treatment period
Measured: 6 months
Percentage of patients with improvement in the "cancerization filed" by RCM score
Comparison between treatment groups at the end of the treatment period Validation of a new RCM score
Measured: 6 months
Percentage of patients compliant to treatment
Comparison between treatment groups at the end of the treatment period
Measured: 6 months
Percentage of patients which report satisfaction to local tolerability
Comparison between treatment groups over time and at the end of the treatment period
Measured: 6 months
Number of patients with AEs and local AEs (skin reactions)
Comparison between treatment groups over time and at the end of the treatment period
Measured: 6 months
Percentage of patients which report satisfaction to treatment
Comparison between treatment groups at the end of the treatment period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ISDIN
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Giuseppe Argenziano,, MD, PhD, Principal investigator, Dermatology Unit, Medical Department /Arcispedale Santa Maria Nuova /Reggio Emilia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656226
- Sponsor's protocol ID
- ISD-FPT-01-2012
- Status last verified
- Aug 2012
- First submitted
- 24 Jul 2012
- Last updated
- 11 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-blind Parallel-group Study to Evaluate the Long-term Effects of Eryfotona AK-NMSC® Cream in the Treatment of Cancerization Field in Patients With Actinic Keratosis.
- ClinicalTrials.gov ID
- NCT01656226
- Acronym / sponsor ID
- ISD-FPT-01-2012
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis, AK
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ISDINIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 2 Aug 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.
The purpose of this study is to assess the efficacy, safety and tolerability of Eryfotona AK-NMSC® topical application vs Sunscreen on cancerization field of actinic keratosis patients after 6 months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eryfotona AK-NMSC® cream | Experimental | Device: Eryfotona AK-NMSC® cream |
| Sunscreen SPF 50+ | Other | Other: Sunscreen SPF 50+ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current diagnosis of AK, with ≥4 lesions located in the same anatomical district (within a contiguous 50 cm2 area on the face, bold scalp or forehead);
- Female or male >18 years of age;
- Skin type I or II according to Fitzpatrick;
- Patient has confirmed his/her willingness to participate in this study;.
Key exclusion criteria (13 listed)
- Topical drug therapy for AK within the past 3 months or for photoaging in the last 6 months, or had lesion-directed therapy within 2 cm2 of the selected AK area during the previous month;
- Suitable for surgical, photodynamic or any other topical treatment in the next 6 months;
- Subjects who suffer/ had suffered from skin cancer or show an early stage of skin cancer or have a genetic predisposition for skin cancer;
- Other skin disease that requires treatment with other medications in the treatment area or in the distance of 3 cm;
- Immunosuppression or current treatment for cancer;
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 |
|---|---|---|
| Eryfotona AK-NMSC® creamCream, to be applied according to COLIPA standard at 2 mg/cm² in head and neck, twice a day before exposing to sun light morning and around lunchtime (about 4-6 hours later), for up to 6 months. | Device | Eryfotona AK-NMSC® cream |
| Sunscreen SPF 50+Cream, to be applied according to COLIPA standard at 2 mg/cm² in head and neck, twice a day before exposing to sun light morning and around lunchtime (about 4-6 hours later), for up to 6 months. | Other | Sunscreen SPF 50+ |
Primary outcome
Percentage of patients with partial clearance of AK lesions
Time frame: 6 months
Comparison between treatment groups at the end of the treatment period
11 secondary outcomes
Percentage of patients with clearance and improvement of AK lesions
Time frame: 6 months
Total number of AK lesions in the treated area (including all lesions present at baseline as well as subclinical lesions which appeared during therapy)
Time frame: 6 months
Percentage of patients with improvement (clinical and dermoscopic assessment) of the target area as for the erythema, scaling, pigmentation and follicular plugs
Time frame: 6 months
Percentage of patients with changes in the Investigator Global Improvement Index
Time frame: 6 months
Percentage of patients with changes in Baseline Severity Index (BSI)
Time frame: 6 months
Percentage of patients with improvement in the target AK lesion by using RCM score.
Time frame: 6 months
Percentage of patients with improvement in the "cancerization filed" by RCM score
Time frame: 6 months
Percentage of patients compliant to treatment
Time frame: 6 months
Percentage of patients which report satisfaction to local tolerability
Time frame: 6 months
Number of patients with AEs and local AEs (skin reactions)
Time frame: 6 months
Percentage of patients which report satisfaction to treatment
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2013.
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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.
Dr. Giuseppe Argenziano,, MD, PhD principal investigator
Dermatology Unit, Medical Department /Arcispedale Santa Maria Nuova /Reggio Emilia, Italy
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 Eryfotona AK-NMSC® cream and Sunscreen SPF 50+ in people with Actinic Keratosis, run by ISDIN 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 4 inclusion and 13 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 11 Oct 2013. 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?
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?
Percentage of patients with partial clearance of AK lesions (time frame: 6 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 11 Oct 2013.