NCT01656226

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 2, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

October 11, 2013

Status Verified

August 1, 2012

Enrollment Period

1.5 years

First QC Date

July 24, 2012

Last Update Submit

October 10, 2013

Conditions

Actinic Keratosis

Keywords

Actinic KeratosisAK

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with partial clearance of AK lesions

    Comparison between treatment groups at the end of the treatment period

    6 months

Secondary Outcomes (11)

  • Percentage of patients with clearance and improvement of AK lesions

    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)

    6 months

  • Percentage of patients with improvement (clinical and dermoscopic assessment) of the target area as for the erythema, scaling, pigmentation and follicular plugs

    6 months

  • Percentage of patients with changes in the Investigator Global Improvement Index

    6 months

  • Percentage of patients with changes in Baseline Severity Index (BSI)

    6 months

  • +6 more secondary outcomes

Study Arms (2)

Eryfotona AK-NMSC® cream

EXPERIMENTAL
Device: Eryfotona AK-NMSC® cream

Sunscreen SPF 50+

OTHER
Other: Sunscreen SPF 50+

Interventions

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.

Eryfotona AK-NMSC® cream
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.

Sunscreen SPF 50+

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology Unit, Medical Department Arcispedale Santa Maria Nuova

Reggio Emilia, Italy

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dr. Giuseppe Argenziano,, MD, PhD

    Dermatology Unit, Medical Department /Arcispedale Santa Maria Nuova /Reggio Emilia, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2012

First Posted

August 2, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

October 11, 2013

Record last verified: 2012-08

Locations

IT(1)