EdemaPhase 2NCT01172522
Topical Treatment of Under Eye Dark Circles and Swelling
A Phase 2 study testing Fexofenadine in people with Edema, run by The Connecticut Sinus Center, PC at 1 site in United States.
Trial summary
This study examines topical treatment of under eye circles and swelling. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edema
- What is being tested?
- Fexofenadine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jan 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Under eye dark circles and swelling
Who cannot join
- Under age 18
- Allergy to tested medicines
Trial locations and contacts
1 site in 1 country.
About this study
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
This study examines topical treatment of under eye circles and swelling.
Read the detailed description
This study examines topical treatment of under eyes dark circles and under eye swelling.
- Conditions
- Edema
- Being tested
- Fexofenadine, Placebo
- Keywords
- Under eye dark circles, Under eye puffiness
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FexofenadineDrug
Also called Topical fexofenadine
Fexofenadine 1%
PlaceboDrug
Also called Topical placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Fexofenadine left; placebo right | Experimental | Topical treatment active versus placebo.
Double blind randomized placebo controlled split face intrasubject comparison. Receives: Drug: Fexofenadine; Drug: Placebo |
| Fexofenadine right; placebo left | Experimental | Split face double blind Receives: Drug: Fexofenadine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention
Efficacy was measured per intervention by assessing number of participants with improvement in under eye dark circles and swelling. Criteria used to assess under eye improvement and swelling was by a 5 point scale comparing each week's photographic appearance to the appearance at baseline: 1) fexofenadine right and placebo left, and 2) fexofenadine left and placebo right. The split face comparison was noted in efficacy measured changes in under eye swelling and dark circles relative to baseline. Participants were graded by 2 blinded dermatologists who reviewed photographs of all participants at entry and weekly until end of study plus one week, day 37. Total number of participants: 30. Placebo right and fexofenadine left 15 participants. Placebo left and fexofenadine right 15 participants.
Measured: Baseline, weekly, and end of study +7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Connecticut Sinus Center, PC
- Sponsor type
- University, hospital or other
- Collaborators
- TKL Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Edward M Lane, MD, Study director, The Connecticut Sinus Center, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172522
- Sponsor's protocol ID
- CS910510
- Status last verified
- Feb 2015
- First submitted
- 28 Jul 2010
- Last updated
- 19 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01172522
- Acronym / sponsor ID
- CS910510
- Conditions
- Edema
- Keywords
- Under eye dark circles, Under eye puffiness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Connecticut Sinus Center, PCUniversity, hospital or other
- Collaborators
- TKL Research, Inc.
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 29 Jul 2010 (estimated)
- Results
- Posted 19 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines topical treatment of under eye circles and swelling.
Detailed description
This study examines topical treatment of under eyes dark circles and under eye swelling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fexofenadine left; placebo right | Experimental | Drug: Fexofenadine, Drug: PlaceboTopical treatment active versus placebo. Double blind randomized placebo controlled split face intrasubject comparison. |
| Fexofenadine right; placebo left | Experimental | Drug: Fexofenadine, Drug: PlaceboSplit face double blind |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Under eye dark circles and swelling
Key exclusion criteria (2 listed)
- Under age 18
- Allergy to tested medicines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FexofenadineAlso: Topical fexofenadineFexofenadine 1% | Drug | Fexofenadine left; placebo right, Fexofenadine right; placebo left |
| PlaceboAlso: Topical placeboPlacebo | Drug | Fexofenadine left; placebo right, Fexofenadine right; placebo left |
Primary outcome
Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention
Time frame: Baseline, weekly, and end of study +7 days
Efficacy was measured per intervention by assessing number of participants with improvement in under eye dark circles and swelling. Criteria used to assess under eye improvement and swelling was by a 5 point scale comparing each week's photographic appearance to the appearance at baseline: 1) fexofenadine right and placebo left, and 2) fexofenadine left and placebo right. The split face comparison was noted in efficacy measured changes in under eye swelling and dark circles relative to baseline. Participants were graded by 2 blinded dermatologists who reviewed photographs of all participants at entry and weekly until end of study plus one week, day 37. Total number of participants: 30. Placebo right and fexofenadine left 15 participants. Placebo left and fexofenadine right 15 participants.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward M Lane, MD study director
The Connecticut Sinus Center, PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fexofenadine in people with Edema, run by The Connecticut Sinus Center, PC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Showed Improvement in Under Eye Swelling and Dark Circles Relative to Baseline Per Intervention (time frame: Baseline, weekly, and end of study +7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2015.