Civamide Patch Safety, Tolerability and PK Study

This study has been completed.
Sponsor:
Information provided by:
Winston Laboratories
ClinicalTrials.gov Identifier:
NCT00758433
First received: September 23, 2008
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

To evaluate the tolerability of two different strengths of a Civamide Patch (0.0075% and 0.0150%) compared to the placebo patch and each other in healthy adult volunteers. To assess the pharmacokinetics of civamide and to determine if there is systemic absorption of the drug from civamide patch in a subset of study subjects.


Condition Intervention Phase
Healthy Volunteers
Drug: Zucapsaicin
Drug: Placebo patch
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Randomized, Double-Blind, Placebo-Controlled Evaluation of the Tolerability of Two Civamide (Zucapsaicin) Patch Strengths Compared to Placebo Patch in Healthy Volunteers

Further study details as provided by Winston Laboratories:

Primary Outcome Measures:
  • Subject's Rating of Stinging and Burning Sensation [ Time Frame: 7 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 7 Days ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: September 2008
Study Completion Date: April 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Civamide patch 0.0075%
Drug: Zucapsaicin
Civamide patch 0.0075% q.d. 24 hours for 7 days
Other Name: Civamide
Active Comparator: 2
Civamide patch 0.0150%
Drug: Zucapsaicin
Civamide patch 0.0150% q.d. 24 hours for 7 days
Other Name: Civamide
Placebo Comparator: 3
Placebo patch
Drug: Placebo patch
Placebo patch q.d. 24 hours for 7 days
Other Name: placebo

Detailed Description:

This is a double-blind, randomized study of the tolerability of two different strengths of a Civamide Patch compared to placebo patch. The study consists of a Screening Period (Days -21 to Day 1), a one week Treatment Period (Days 1-8) and a follow-up telephone call to subjects on Day 10.

Pharmacokinetics will be assessed relative to dosing on Day 1, Day 2, and Day 8 in a subset of subjects. Subjects will also rate stinging and burning sensation at the application site during the Treatment Period.

Twenty-four (24) hours after the last patch application, subjects will return to the study site on Day 8. The treatment area will be evaluated by the Study Physician. Subjects will complete a Subject's Global Rating of Stinging and Burning Sensation and a Subject's Global Rating of Tolerability.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion Criteria

  1. Subject voluntarily agrees to participate in this study and signs an IRB- approved informed consent prior to performing any of the screening procedures.
  2. Subject is healthy, determined by pre-study medical evaluation medical history, physical examination of the treatment area, and vital signs).
  3. Males or females between 18 to 60 years of age, inclusive.
  4. Non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (abstinence, hormonal contraceptives, diaphragm with spermicide, condom with spermicide, or intrauterine device) from Screening to Day 10 follow-up or females of nonchildbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year).
  5. Subject has a blood pressure reading lower than or equal to 144/92 mmHg.
  6. Subject has an oral temperature reading lower than 99.6F.
  7. Subjects must have an area of the skin on the abdomen that is without active skin disease, infection, severe erythema, or other compromise in the integrity of the skin at or near the intended treatment area.
  8. The subject has no visual or motor impairments that will make it difficult to complete the VAS scales or apply the patch.
  9. Non-smoker as determined by history over the past year.
  10. Subject has a body mass index (BMI) between 18.5 and 30.5 kg/m2, in pk subset only.
  11. Subject is willing and able to cooperate to the extent required by the protocol.

Exclusion Criteria:

  1. Subject has known allergy or hypersensitivity to

    • a) Civamide, capsicum, or capsaicin-containing products,
    • b) any other ingredient of the patch or
    • c) adhesives.
  2. Presence of any cutaneous abnormality or condition that may adversely impact the application of the test patches.
  3. History of frequent headache or other painful conditions within the past 30 days that has required or is expected to require the chronic use of prescription or over the counter pain relief medications, such as non- steroidal anti-inflammatory agents, including COX-2 inhibitors, systemic opiates or derivatives, or acetaminophen, prior to Day 1 or within 48 hours prior to Day 1.
  4. Use of alcohol or alcohol-containing foods, medications or beverages within 24 hours prior to Day 1 until after the completion of the Study on Day 10.
  5. Topical use of any moisturizer or medicated products on or near the treatment area within 48 hours of Day 1 until after the completion of the Study on Day 10.
  6. Topical use of any capsaicin-containing product for 60 days prior to Day 1 until completion of the Study on Day 10.
  7. Subject has a history of alcohol and/or drug abuse within two years of study entry.
  8. Female subjects who are breastfeeding.
  9. Unwilling to maintain usual consumption of caffeine containing beverages within 24 hours prior to Day -1 until completion of Day 8.
  10. Subject is unwilling to abstain from vigorous exercise for 48 hours prior to Day 1 until completion of the Study on Day 10.
  11. Subject is unwilling to abstain from swimming, baths and prolonged with direct stream of water when showering from Day 1 until Day 8
  12. Use of an investigational drug within 30 days prior to Day 1.
  13. Donation of blood (> 250 ml) or blood products within 2 months (56 days) prior to Day 1.
  14. Ingestion of any capsaicin-containing foods for 24 hours before Day 1 and during the study.
  15. If for any other reason the subject is not deemed to be healthy by the investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758433

Locations
United States, New York
International Research Services, Inc.
Port Chester, New York, United States, 10573
Sponsors and Collaborators
Winston Laboratories
Investigators
Study Director: Scott B Phillips, M.D. Winston Laboratories
  More Information

No publications provided

Responsible Party: Scott B. Phillips, M.D., Study Director, Winston Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00758433     History of Changes
Other Study ID Numbers: WL-1001-04-01
Study First Received: September 23, 2008
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Winston Laboratories:
Adverse Events
Erythema Rating
Pharmacokinetics
Civamide
Phase 1
Pain
Patch

Additional relevant MeSH terms:
Capsaicin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014