NCT01806961

Brief Summary

Determine the recurrence rate of actinic keratosis (AK) lesions in patients with complete clinical clearance at the end of the previous trial SP848-AK-1101 at 6 and 12 months of follow-up.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
2 countries

9 active sites

Status
terminated

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

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

January 20, 2016

Completed
Last Updated

August 3, 2016

Status Verified

May 1, 2016

Enrollment Period

5 months

First QC Date

March 6, 2013

Results QC Date

December 14, 2015

Last Update Submit

June 21, 2016

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

  • Determine the Recurrence Rate of AK-lesions

    Number of patients with persistent complete clearance at 6 and 12 months follow-up. Recurrence rate is to be determined at the same treatment area where the investigational medicinal products were administered in the previous trial.

    at 6 and 12 months

Secondary Outcomes (2)

  • Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes)

    at 6 and 12 months

  • Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area

    at 6 and 12 months

Study Arms (1)

clearance at end of trial SP848-AK-1101

no trial medication during this follow-up trial

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with complete clinical clearance (i.e. no previously existing AK-lesion present) at the end of the trial SP848-AK-1101 or Non- Responder who withdrew from the trial prematurely.

You may qualify if:

  • Signed informed consent.
  • Participation in the previous clinical trial SP848-AK-1101.
  • Patient with complete clinical clearance (i.e. no previously existing AK-lesion present) at the end of the trial SP848-AK-1101 or Non-Responder who withdrew from the trial prematurely.

You may not qualify if:

  • Evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., cardiovascular, immunological, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, infectious, gastrointestinal abnormalities or diseases).
  • Evidence of systemic cancer.
  • Dermatological disease or condition in the former treatment or surrounding area that might impair trial assessments (e.g., rosacea, atopic dermatitis, eczema) as assessed by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hauttumorcentrum Charité (HTCC)

Berlin, Germany

Location

Medizinisches Zentrum Bonn - Friedensplatz

Bonn, Germany

Location

Hautzentrum

Düsseldorf, Germany

Location

Johannes Wesling Klinikum Minden

Minden, Germany

Location

KLINIKUM VEST GmbH Knappschaftskrankenhaus

Recklinghausen, Germany

Location

Universitätsspital Basel

Basel, Switzerland

Location

Inselspital

Bern, Switzerland

Location

Kantonsspital St.Gallen

Sankt Gallen, Switzerland

Location

Universitaetsspital Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Limitations and Caveats

No efficacy analysis was carried out since due to premature study termination (upon Sponsor's decision) no data was available for analysis

Results Point of Contact

Title
Dr. Francine Santoro
Organization
Sipirig AG
francine.santoro@galderma.com
+41 62 387 87 87

Study Officials

  • Lars E French, MD

    University Clinic of Dermatology, Zurich

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2013

First Posted

March 7, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2013

Study Completion

September 1, 2013

Last Updated

August 3, 2016

Results First Posted

January 20, 2016

Record last verified: 2016-05

Locations

CH(4)DE(5)