Know Cancer

or
forgot password

Observational (Non-interventional), Follow-up Trial Assessing Long-term Local Tolerability and Efficacy (Recurrence Rate) of Resiquimod Gel in Patients Treated for Actinic Keratosis.


N/A
18 Years
N/A
Open (Enrolling)
Both
Actinic Keratosis

Thank you

Trial Information

Observational (Non-interventional), Follow-up Trial Assessing Long-term Local Tolerability and Efficacy (Recurrence Rate) of Resiquimod Gel in Patients Treated for Actinic Keratosis.


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Determine the recurrence rate of AK-lesions

Outcome Description:

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.

Outcome Time Frame:

at 6 and 12 months

Safety Issue:

No

Principal Investigator

Lars E French, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Clinic of Dermatology, Zurich

Authority:

Switzerland: Ethikkommission

Study ID:

SP848-AKEx-1209

NCT ID:

NCT01806961

Start Date:

February 2013

Completion Date:

August 2015

Related Keywords:

  • Actinic Keratosis
  • Keratosis
  • Keratosis, Actinic

Name

Location