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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: February 11, 2013
Last verified: February 2013
History of Changes
  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:

MedlinePlus related topics: Edema
U.S. FDA Resources

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
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: February 11, 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:
Edema
Signs and Symptoms
Ibuprofen
Fexofenadine
Terfenadine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
 Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 19, 2013