Lower Eyelid Steatoblepharon (Excess Eyelid Fat)Phase 2NCT02230761
Phase 2 Study of XAF5 (XOPH5) Ointment for Reduction of Excess Eyelid Fat (Steatoblepharon)
A Phase 2 study testing XOPH5 Ointment in people with Lower Eyelid Steatoblepharon (Excess Eyelid Fat), run by Topokine Therapeutics, Inc. at 1 site in United States.
Trial summary
This study will test whether XAF5 (XOPH5) ointment, applied once daily to the lower eyelids for 10 weeks, reduces the prominence of lower eyelid fat in adults with moderate to severe steatoblepharon (excess eyelid fat). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Lower Eyelid Steatoblepharon (Excess Eyelid Fat)
- What is being tested?
- XOPH5 Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2014
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe lower eyelid steatoblepharon (LESS score of 2-4 bilaterally)
- Men and women 40-70 years old
- Healthy facial skin
- Must understand and provide informed consent
Who cannot join
- Best corrected visual acuity worse than 20/40 in either eye
- Regular use of ophthalmic medication in either eye
- Planned use of contact lenses during the study
- Any history of lower eyelid surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Topokine Therapeutics Clinical Study Centers
Boston, Massachusetts, 02111
About this study
Official title: A Phase 2, Randomized, Double-masked, Placebo-controlled Study of XOPH5 Ointment for Reduction of Lower Lid Steatoblepharon
This study will test whether XAF5 (XOPH5) ointment, applied once daily to the lower eyelids for 10 weeks, reduces the prominence of lower eyelid fat in adults with moderate to severe steatoblepharon (excess eyelid fat).
- Being tested
- XOPH5 Ointment, Placebo
- Keywords
- steatoblepharon, blepharoptosis, dermatochalasis, blepharoplasty, periorbital, orbital, eyelid, eyebags, eye bags
- Medical subject headings
- Blepharoptosis, Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XOPH5 OintmentDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| XOPH5 Ointment | Experimental | XOPH5 Ointment is the investigational drug to be studied. Receives: Drug: XOPH5 Ointment |
| Placebo Ointment | Placebo comparator | Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported
Photonumeric scale, range 0-4, 0 is absence of steatoblepharon, 4 is very severe steatoblepharon.
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
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 Lower Eyelid Steatoblepharon (Excess Eyelid Fat)Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topokine Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael S. Singer, MD, PhD, Study chair, Topokine Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230761
- Sponsor's protocol ID
- XOPH5-OINT-2
- Status last verified
- Dec 2015
- First submitted
- 28 Aug 2014
- Last updated
- 8 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-masked, Placebo-controlled Study of XOPH5 Ointment for Reduction of Lower Lid Steatoblepharon
- ClinicalTrials.gov ID
- NCT02230761
- Acronym / sponsor ID
- XOPH5-OINT-2
- Keywords
- steatoblepharon, blepharoptosis, dermatochalasis, blepharoplasty, periorbital, orbital, eyelid, eyebags
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Topokine Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Posted 8 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test whether XAF5 (XOPH5) ointment, applied once daily to the lower eyelids for 10 weeks, reduces the prominence of lower eyelid fat in adults with moderate to severe steatoblepharon (excess eyelid fat).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XOPH5 Ointment | Experimental | Drug: XOPH5 OintmentXOPH5 Ointment is the investigational drug to be studied. |
| Placebo Ointment | Placebo comparator | Drug: PlaceboPlacebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Moderate to severe lower eyelid steatoblepharon (LESS score of 2-4 bilaterally)
- Men and women 40-70 years old
- Healthy facial skin
- Must understand and provide informed consent
Key exclusion criteria (4 listed)
- Best corrected visual acuity worse than 20/40 in either eye
- Regular use of ophthalmic medication in either eye
- Planned use of contact lenses during the study
- Any history of lower eyelid surgery
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 |
|---|---|---|
| XOPH5 Ointment | Drug | XOPH5 Ointment |
| Placebo | Drug | Placebo Ointment |
Primary outcome
Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported
Time frame: 11 weeks
Photonumeric scale, range 0-4, 0 is absence of steatoblepharon, 4 is very severe steatoblepharon.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Michael S. Singer, MD, PhD study chair
Topokine Therapeutics, Inc.
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 XOPH5 Ointment in people with Lower Eyelid Steatoblepharon (Excess Eyelid Fat), run by Topokine Therapeutics, Inc. 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 4 inclusion and 4 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 8 Feb 2016. 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. Some participants in this study may receive a placebo. 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 8 Feb 2016). 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?
Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported (time frame: 11 weeks). 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 8 Feb 2016.