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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by ISDIN.
Recruitment status was  Active, not recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014