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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ISDIN
ClinicalTrials.gov Identifier:
NCT01656226
First received: July 24, 2012
Last updated: October 10, 2013
Last verified: August 2012
  Purpose

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 Intervention Phase
Actinic Keratosis
Device: Eryfotona AK-NMSC® cream
Other: Sunscreen SPF 50+
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by ISDIN:

Primary Outcome Measures:
  • Percentage of patients with partial clearance of AK lesions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Comparison between treatment groups at the end of the treatment period


Secondary Outcome Measures:
  • Percentage of patients with clearance and improvement of AK lesions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Comparison between treatment groups at the end of the treatment period

  • 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 ] [ Designated as safety issue: No ]
    Comparison between treatment groups at the end of the treatment period

  • 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 ] [ Designated as safety issue: No ]
    Comparison between treatment groups at the end of the treatment period

  • Percentage of patients with changes in the Investigator Global Improvement Index [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Comparison between treatment groups at the end of the treatment period

  • Percentage of patients with changes in Baseline Severity Index (BSI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Comparison between treatment groups at the end of the treatment period

  • Percentage of patients with improvement in the target AK lesion by using RCM score. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Comparison between treatment groups at the end of the treatment period

  • Percentage of patients with improvement in the "cancerization filed" by RCM score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Comparison between treatment groups at the end of the treatment period Validation of a new RCM score

  • Percentage of patients compliant to treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Comparison between treatment groups at the end of the treatment period

  • Percentage of patients which report satisfaction to local tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Comparison between treatment groups over time and at the end of the treatment period

  • Number of patients with AEs and local AEs (skin reactions) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Comparison between treatment groups over time and at the end of the treatment period

  • Percentage of patients which report satisfaction to treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Comparison between treatment groups at the end of the treatment period


Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656226

Locations
Italy
Dermatology Unit, Medical Department Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
Sponsors and Collaborators
ISDIN
Investigators
Principal Investigator: Dr. Giuseppe Argenziano, , MD, PhD Dermatology Unit, Medical Department /Arcispedale Santa Maria Nuova /Reggio Emilia, Italy
  More Information

No publications provided

Responsible Party: ISDIN
ClinicalTrials.gov Identifier: NCT01656226     History of Changes
Other Study ID Numbers: ISD-FPT-01-2012
Study First Received: July 24, 2012
Last Updated: October 10, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by ISDIN:
Actinic Keratosis
AK

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014