Civamide Patch Safety, Tolerability and PK Study

NCT00758433 | Completed Phase 1

• 1 other identifier: WL-1001-04-01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Adverse Events; Erythema Rating; Pharmacokinetics; Civamide; Phase 1; Pain; Patch

Outcome Measures

Primary Outcomes (1)

• Subject's Rating of Stinging and Burning Sensation

  7 Days

Secondary Outcomes (1)

• Pharmacokinetics

  7 Days

Study Arms (3)

1

ACTIVE COMPARATOR

Civamide patch 0.0075%

Drug: Zucapsaicin

2

ACTIVE COMPARATOR

Civamide patch 0.0150%

Drug: Zucapsaicin

3

PLACEBO COMPARATOR

Placebo patch

Drug: Placebo patch

Interventions

Zucapsaicin DRUG

Civamide patch 0.0075% q.d. 24 hours for 7 days

Also known as: Civamide

1

Placebo patch DRUG

Placebo patch q.d. 24 hours for 7 days

Also known as: placebo

3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject voluntarily agrees to participate in this study and signs an IRB- approved informed consent prior to performing any of the screening procedures.
• Subject is healthy, determined by pre-study medical evaluation medical history, physical examination of the treatment area, and vital signs).
• Males or females between 18 to 60 years of age, inclusive.
• 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).
• Subject has a blood pressure reading lower than or equal to 144/92 mmHg.
• Subject has an oral temperature reading lower than 99.6F.
• 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.
• The subject has no visual or motor impairments that will make it difficult to complete the VAS scales or apply the patch.
• Non-smoker as determined by history over the past year.
• Subject has a body mass index (BMI) between 18.5 and 30.5 kg/m2, in pk subset only.
• Subject is willing and able to cooperate to the extent required by the protocol.

You may not qualify if:

• Subject has known allergy or hypersensitivity to
• a) Civamide, capsicum, or capsaicin-containing products,
• b) any other ingredient of the patch or
• c) adhesives.
• Presence of any cutaneous abnormality or condition that may adversely impact the application of the test patches.
• 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.
• 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.
• 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.
• Topical use of any capsaicin-containing product for 60 days prior to Day 1 until completion of the Study on Day 10.
• Subject has a history of alcohol and/or drug abuse within two years of study entry.
• Female subjects who are breastfeeding.
• Unwilling to maintain usual consumption of caffeine containing beverages within 24 hours prior to Day -1 until completion of Day 8.
• Subject is unwilling to abstain from vigorous exercise for 48 hours prior to Day 1 until completion of the Study on Day 10.
• Subject is unwilling to abstain from swimming, baths and prolonged with direct stream of water when showering from Day 1 until Day 8
• Use of an investigational drug within 30 days prior to Day 1.

Sponsors & Collaborators

• Winston Laboratories: lead

Study Sites (1)

International Research Services, Inc.

Port Chester, New York, 10573, United States

Location

MeSH Terms

Conditions

Pain

Interventions

zucapsaicin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott B Phillips, M.D.

  Winston Laboratories

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 25, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: April 1, 2009
• Last Updated: June 10, 2011

Record last verified: 2011-06

Locations

US (1)