Know Cancer

or
forgot password

Bi-center, Open Label, Non-comparative Trial Exploring Efficacy and Safety of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma (nBCC)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Nodular Basal Cell Carcinoma

Thank you

Trial Information

Bi-center, Open Label, Non-comparative Trial Exploring Efficacy and Safety of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma (nBCC)


Inclusion Criteria:



- Signed consent form.

- Male or non-pregnant, non-lactating female, ≥ 18 years.

- Must have a previously untreated, histologically confirmed nBCC on head, neck, trunk
or arms.

- nBCC must not be larger than 20 mm in diameter and must be less than 5 mm in depth.

- Willing and able to participate in the trial as an outpatient and comply with all
trial requirements.

Exclusion Criteria:

- nBCC located close to or at mouth or eyes.

- Patients who have had an organ transplant.

- Known autoimmune disorder (especially psoriasis), impaired immune system (e.g. HIV),
known thyroid abnormalities, known depression.

- An open wound or an infection in treatment area.

- Dermatological disease or condition (e.g. rosacea, atopic dermatitis, eczema) in the
treatment or surrounding area that might impair trial assessments.

- Evidence of an active infection or systemic cancer.

- Flu or flu-like symptoms (including general indisposition, fever, nausea, muscle
pain, chills) within a week before start of the trial.

- Known allergy or hypersensitivity to any of the trial gel ingredients.

- Evidence of unstable or uncontrolled clinically significant medical conditions as
determined by the investigator (e.g., renal or hepatic disease).

- Current alcohol abuse or chemical dependency as assessed by the investigator.

- Patient who is detained or committed to an institution by a law court or by legal
authorities.

- Participation in another clinical trial within one month before start of the trial.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Histological cure rate

Outcome Time Frame:

8 weeks after a maximal treatment period of 4 weeks

Safety Issue:

No

Authority:

Switzerland: Ethikkommission

Study ID:

SP848-nBCC-1104

NCT ID:

NCT01808950

Start Date:

January 2013

Completion Date:

March 2014

Related Keywords:

  • Nodular Basal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Basal Cell

Name

Location