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Topical Treatment of Under Eye Dark Circles and Swelling

This study has been completed.
Sponsor:
Collaborator:
TKL Research, Inc.
Information provided by (Responsible Party):
The Connecticut Sinus Center, PC
ClinicalTrials.gov Identifier:
NCT01172522
First received: July 28, 2010
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

This study examines topical treatment of under eye circles and swelling.


Condition Intervention Phase
Edema
Drug: Fexofenadine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Randomized Double Blind Study to Assess the Safety and Efficacy of 1% Ibuprofen/ 1%Fexofenadine Topical Cream for the Treatment of Dark Circles Under the Eyes

Resource links provided by NLM:


Further study details as provided by The Connecticut Sinus Center, PC:

Primary Outcome Measures:
  • Change in puffiness and dark circles relative to baseline [ Time Frame: Baseline, 29 days ] [ Designated as safety issue: No ]
    Efficacy of actives versus placebo


Enrollment: 30
Study Start Date: September 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo

Topical treatment active versus placebo.

Double blind randomized placebo controlled split face intrasubject comparison.

Drug: Placebo
Placebo
Experimental: Fexofenadine

Topical treatment active versus placebo.

Double blind randomized placebo controlled split face intrasubject comparison.

Drug: Fexofenadine
Fexofenadine 1%
Other Name: Fexofenadine, Ibuprofen

Detailed Description:

This study examines topical treatment of under eye circles and swelling.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Under eye dark circles and swelling

Exclusion Criteria:

  • Under age 18
  • Allergy to tested medicines
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172522

Locations
United States, New Jersey
TKL Research
Paramus, New Jersey, United States, 07652
Sponsors and Collaborators
The Connecticut Sinus Center, PC
TKL Research, Inc.
Investigators
Study Director: Edward M Lane, MD The Connecticut Sinus Center, PC
  More Information

No publications provided

Responsible Party: The Connecticut Sinus Center, PC
ClinicalTrials.gov Identifier: NCT01172522     History of Changes
Other Study ID Numbers: CS910510
Study First Received: July 28, 2010
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The Connecticut Sinus Center, PC:
Under eye dark circles
Under eye puffiness

Additional relevant MeSH terms:
Fexofenadine
Ibuprofen
Terfenadine
Analgesics
Analgesics, Non-Narcotic
Anti-Allergic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014