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Long Term Efficacy and Safety of Eryfotona AK-NMSC® in Patients With Actinic Keratosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01656226
Recruitment Status : Unknown
Verified August 2012 by ISDIN.
Recruitment status was:  Active, not recruiting
First Posted : August 2, 2012
Last Update Posted : October 11, 2013
Sponsor:
Information provided by (Responsible Party):
ISDIN

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Device: Eryfotona AK-NMSC® cream Other: Sunscreen SPF 50+ Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : July 2012
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sun Exposure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Eryfotona AK-NMSC® cream Device: Eryfotona AK-NMSC® cream
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: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients with partial clearance of AK lesions [ Time Frame: 6 months ]
    Comparison between treatment groups at the end of the treatment period


Secondary Outcome Measures :
  1. Percentage of patients with clearance and improvement of AK lesions [ Time Frame: 6 months ]
    Comparison between treatment groups at the end of the treatment period

  2. 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 ]
    Comparison between treatment groups at the end of the treatment period

  3. 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 ]
    Comparison between treatment groups at the end of the treatment period

  4. Percentage of patients with changes in the Investigator Global Improvement Index [ Time Frame: 6 months ]
    Comparison between treatment groups at the end of the treatment period

  5. Percentage of patients with changes in Baseline Severity Index (BSI) [ Time Frame: 6 months ]
    Comparison between treatment groups at the end of the treatment period

  6. Percentage of patients with improvement in the target AK lesion by using RCM score. [ Time Frame: 6 months ]
    Comparison between treatment groups at the end of the treatment period

  7. Percentage of patients with improvement in the "cancerization filed" by RCM score [ Time Frame: 6 months ]
    Comparison between treatment groups at the end of the treatment period Validation of a new RCM score

  8. Percentage of patients compliant to treatment [ Time Frame: 6 months ]
    Comparison between treatment groups at the end of the treatment period

  9. Percentage of patients which report satisfaction to local tolerability [ Time Frame: 6 months ]
    Comparison between treatment groups over time and at the end of the treatment period

  10. Number of patients with AEs and local AEs (skin reactions) [ Time Frame: 6 months ]
    Comparison between treatment groups over time and at the end of the treatment period

  11. Percentage of patients which report satisfaction to treatment [ Time Frame: 6 months ]
    Comparison between treatment groups at the end of the treatment period


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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);
  2. Female or male >18 years of age;
  3. Skin type I or II according to Fitzpatrick;
  4. Patient has confirmed his/her willingness to participate in this study;.

Exclusion Criteria:

  1. 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;
  2. Suitable for surgical, photodynamic or any other topical treatment in the next 6 months;
  3. Subjects who suffer/ had suffered from skin cancer or show an early stage of skin cancer or have a genetic predisposition for skin cancer;
  4. Other skin disease that requires treatment with other medications in the treatment area or in the distance of 3 cm;
  5. Immunosuppression or current treatment for cancer;
  6. Clinically unstable medical condition;
  7. High risk group for HIV infection or presentation of other infectious diseases
  8. Presentation of contact allergies or allergies to compounds of the test substances;
  9. Smoker (more than forty cigarettes per day) or heavy drinker (more than three standard drinks per day);
  10. Psychiatric disease that may interfere with follow up of study procedures;
  11. Participation in other clinical trials up to 30 days prior to day 1 of the study
  12. Prior treatment with study medication in the area to be treated;
  13. Considered by the investigator, for any other reason, to be an unsuitable candidate for the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656226


Locations
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Italy
Dermatology Unit, Medical Department Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
Sponsors and Collaborators
ISDIN
Investigators
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Principal Investigator: Dr. Giuseppe Argenziano,, MD, PhD Dermatology Unit, Medical Department /Arcispedale Santa Maria Nuova /Reggio Emilia, Italy
More Information
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Responsible Party: ISDIN
ClinicalTrials.gov Identifier: NCT01656226    
Other Study ID Numbers: ISD-FPT-01-2012
First Posted: August 2, 2012    Key Record Dates
Last Update Posted: October 11, 2013
Last Verified: August 2012
Keywords provided by ISDIN:
Actinic Keratosis
AK
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
 Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents