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Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine

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ClinicalTrials.gov Identifier: NCT01380353
Recruitment Status : Active, not recruiting
First Posted : June 27, 2011
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Northwestern University

June 22, 2011
June 27, 2011
November 24, 2017
June 2011
July 2018   (Final data collection date for primary outcome measure)
Compare concentrations of diclofenac epolamine patch when applied to breast vs. abdomen [ Time Frame: after 3 days of treatment prior to surgery ]
The primary objective of this protocol will demonstrate that diclofenac epolamine patch applied to the skin of the breast for three days (1, 2) prior to surgery will result in significantly higher drug concentrations in the breast than the same dose applied to the abdominal skin for the same duration of time.
Same as current
Complete list of historical versions of study NCT01380353 on ClinicalTrials.gov Archive Site
Determine how the concentrations of the study patch is distributed in the breast. [ Time Frame: after three days of treatment prior to surgery ]
To establish that the diclofenac epolamine drug concentrations achieved in the breast have no significant fall-off with increasing distance from the site of application. Therefore, uniform therapeutic concentrations are achieved throughout the breast with a single site of local transdermal therapy (LTT).
Same as current
Not Provided
Not Provided
 
Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine
Pilot Study to Test Uniformity of Transdermal Drug Delivery to the Breast Using Diclofenac Epolamine as a Model

The purpose of this study is to look for ways to improve breast cancer treatment by giving breast cancer drugs through the skin of the breast.

The drug used in this study is a diclofenac epolamine patch and is a nonsteroid anti-inflammatory pain reliever. The drug amount that gathers in the breast, after application of a patch to the skin of the breast, will be measured and compared to the amount that is found in the breast when the patch is applied to the skin of the belly.

This is a randomized study where participants in group 1 will apply the diclofenac epolamine patch to the breast and participants in group 2 will apply the same drug to her abdomen. Participants are instructed to apply a new patch every 12 hours for 3 days. Total participation in this study will be for three days, ending on the day of surgery. On the day of surgery, participants will have blood drawn to measure the level of diclofenac epolamine in the body, and the final patch will be removed.
Interventional
Early Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
Drug: Diclofenac epolamine patch
Patch (10cm X 14cm) is comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner [B].
Other Name: Flecto Patch
  • Experimental: Breast Group
    Diclofenac epolamine patch applied to the breast
    Intervention: Drug: Diclofenac epolamine patch
  • Experimental: Abdomen Group
    Diclofenac epolamine patch applied to the abdomen
    Intervention: Drug: Diclofenac epolamine patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
Same as current
July 2019
July 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women between the ages of 18 and 80 years, undergoing total mastectomy for, with or without axillary surgery for diagnosis or prevention of breast cancer.
  • ECOG performance status less than 2.
  • Ability to understand and the willingness to sign a written informed consent.
  • Participants must have normal organ and marrow function

Exclusion Criteria:

  • Prior history of ipsilateral breast radiotherapy.
  • Pregnant women and those who will be actively breast-feeding in the preoperative period will be excluded.
  • Inability to discontinue aspirin or warfarin use during the period of participation.
  • Known allergy to diclofenac epolamine, or aspirin, diclofenac (Cataflam, Voltaren), or another non-steroidal anti-inflammatory drug (NSAID).
  • Renal failure
Sexes Eligible for Study: Female
18 Years to 80 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01380353
NU 10B05
STU00042939 ( Other Identifier: Northwestern University eIRB )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Northwestern University
Northwestern University
Not Provided
Principal Investigator: Seema Khan, MD Northwestern University
Northwestern University
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP