NCT01358851

Brief Summary

The aim of this study is to evaluate the efficacy and safety of LAS 41005 compared to cryotherapy in subjects with moderate to severe hyperkeratotic actinic keratosis (punch biopsies).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

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

April 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 24, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

May 2, 2011

Last Update Submit

May 28, 2015

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

  • Histological status (AK diagnosis and grade) of one predefined target lesion

    Histological clearance at 8 weeks after end of treatment with LAS 41005, respectively 14 weeks after first cryotherapy. Histological Status will be measured by Histological Biopsy in order to confirm the diagnosis of AK and the grade.

    Screening and 8 weeks after last treatment

Secondary Outcomes (1)

  • Total Actinic keratoses (AK)lesion count at each visit

    day 1, day 21, day 42 and day 98.

Study Arms (2)

1

EXPERIMENTAL

Drug Las41005

Drug: LAS41005

2

OTHER

Cryotherapy

Procedure: Cryotherapy

Interventions

CryotherapyPROCEDURE

1-2 times during the treatment time

2
LAS41005DRUG

once daily

1

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed and dated written informed consent.
  • Men and women aged between 18 and 85 years inclusive.
  • Have a general good and stable health condition as confirmed by a physical examination and by medical history.
  • Have at least 4 but not more than 10 clinically confirmed hyperkeratotic AK target lesions of moderate to severe intensity within the face/forehead or bald scalp
  • Skin type I to IV according to Fitzpatrick's .
  • Are free of any significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment area that may cause difficulty with examination or final evaluation.
  • Physical ability to apply the study preparation correctly and to follow the study restrictions and visit.
  • Women of childbearing potential are allowed to participate in this study, only if they use a highly effective method of contraception

You may not qualify if:

  • Have received treatment of AK within the treatment area (face / scalp) in the three months preceding this clinical trial.
  • Have known hypersensitivity to the ingredients
  • Are subjects under immunosuppressive therapy.
  • Having coagulation defects which are inherited or acquired
  • Have evidence of clinically significant, unstable medical conditions
  • Have currently other malignant or benign tumors of the skin within the treatment area
  • Subjects who have taken topical or systemic treatments that might interfere with the study end points, within a time window that is not allowed, or who are currently taking phenytoin, methotrexate or sulfonylurea.
  • Subjects taking inhibitors of DPD (e.g. Brivudin, Sorivudin)
  • Are known to be pregnant or lactating (currently or within the past 3 months).
  • Have any dermatological disease in the treatment area or surrounding area that may be exacerbated by treatment
  • Are currently or within the past 8 weeks participating in another clinical study.
  • Have active chemical dependency or alcoholism as assessed by the investigator.
  • Subject is institutionalized because of legal or regulatory order.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Almirall investigative site 3

Dülmen, 48249, Germany

Location

Almirall investigative site 1

Leipzig, 04107, Germany

Location

Almirall investigative site 4

Soest, 59494, Germany

Location

Almirall investigative site 2

Wuppertal, 42275, Germany

Location

Related Publications (1)

  • Simon JC, Dominicus R, Karl L, Rodriguez R, Willers C, Dirschka T. A prospective randomized exploratory study comparing the efficacy of once-daily topical 0.5% 5-fluorouracil in combination with 10.0% salicylic acid (5-FU/SA) vs. cryosurgery for the treatment of hyperkeratotic actinic keratosis. J Eur Acad Dermatol Venereol. 2015 May;29(5):881-9. doi: 10.1111/jdv.12702. Epub 2014 Sep 25.

    PMID: 25257941DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Rosario Rodríguez

    Almirall, S.A.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2011

First Posted

May 24, 2011

Study Start

April 1, 2011

Primary Completion

March 1, 2012

Study Completion

August 1, 2012

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

DE(4)