SteatoblepharonPhase 2/3NCT02607683
Phase 2b/3 Study of XAF5 Ointment for Steatoblepharon (Undereye Bags)
A Phase 2/3 study testing XAF5 (concentration A: 0.1%) and XAF5 (concentration B: 0.035%) in people with Steatoblepharon, run by Topokine Therapeutics, Inc. at 6 sites in United States.
Trial summary
This randomized, placebo-controlled, double-masked, Phase 2b/Phase 3 study will assess the efficacy of two different concentrations of XAF5 Ointment for reduction of lower lid steatoblepharon (undereye bags). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Steatoblepharon
- What is being tested?
- XAF5 (concentration A: 0.1%) and XAF5 (concentration B: 0.035%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Jan 2016to 31 Oct 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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, bilateral lower eyelid steatoblepharon
- Must understand and provide informed consent
- Healthy facial skin
Who cannot join
- Pregnant or lactating women
- Clinically significant eye disease
- Best corrected visual acuity worse than 20/40 in either eye
- History of eye surgery in past 6 months
- History of lower eyelid surgery
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Opthalmic Consultants of Boston
Boston, Massachusetts
Cincinatti Eye Institute
Cincinnati, Ohio
Danbury Eye Physicians
Danbury, Connecticut
David Wirta, MD, Inc.
Newport Beach, California
OC Clinical Trials
Santa Ana, California
South Shore Eye Care, Inc.
Wantagh, New York
About this study
Official title: A Phase 2b/3, Multicenter, Dose-ranging, Randomized, Double-masked, Placebo-controlled Study of XAF5 Ointment for Reduction of Lower Lid Steatoblepharon
This randomized, placebo-controlled, double-masked, Phase 2b/Phase 3 study will assess the efficacy of two different concentrations of XAF5 Ointment for reduction of lower lid steatoblepharon (undereye bags).
- Conditions
- Steatoblepharon
- Being tested
- XAF5 (concentration A: 0.1%), XAF5 (concentration B: 0.035%), Matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XAF5 (concentration A: 0.1%)Drug
XAF5 (concentration B: 0.035%)Drug
Matching placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| XAF5 (concentration A: 0.1%) | Experimental | Participants will apply XAF5 Ointment (concentration A: 0.1%) to the lower eyelids once daily. Receives: Drug: XAF5 (concentration A: 0.1%) |
| XAF5 (concentration B: 0.035%) | Experimental | Participants will apply XAF5 Ointment (concentration B: 0.035%) to the lower eyelids once daily. Receives: Drug: XAF5 (concentration B: 0.035%) |
| Placebo | Placebo comparator | Participants will apply Placebo Ointment to the lower eyelids once daily. Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LESS score (Clinician-Reported)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study start1 Jan 2016
- Primary completion19 Sep 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SteatoblepharonStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topokine Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julie Roth, Ph.D., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607683
- Sponsor's protocol ID
- XOPH5-OINT-3
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2015
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b/3, Multicenter, Dose-ranging, Randomized, Double-masked, Placebo-controlled Study of XAF5 Ointment for Reduction of Lower Lid Steatoblepharon
- ClinicalTrials.gov ID
- NCT02607683
- Acronym / sponsor ID
- XOPH5-OINT-3
- Conditions
- Steatoblepharon
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Topokine Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 19 Sep 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, placebo-controlled, double-masked, Phase 2b/Phase 3 study will assess the efficacy of two different concentrations of XAF5 Ointment for reduction of lower lid steatoblepharon (undereye bags).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| XAF5 (concentration A: 0.1%) | Experimental | Drug: XAF5 (concentration A: 0.1%)Participants will apply XAF5 Ointment (concentration A: 0.1%) to the lower eyelids once daily. |
| XAF5 (concentration B: 0.035%) | Experimental | Drug: XAF5 (concentration B: 0.035%)Participants will apply XAF5 Ointment (concentration B: 0.035%) to the lower eyelids once daily. |
| Placebo | Placebo comparator | Drug: Matching placeboParticipants will apply Placebo Ointment to the lower eyelids once daily. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate to severe, bilateral lower eyelid steatoblepharon
- Must understand and provide informed consent
- Healthy facial skin
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- Clinically significant eye disease
- Best corrected visual acuity worse than 20/40 in either eye
- History of eye surgery in past 6 months
- 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 |
|---|---|---|
| XAF5 (concentration A: 0.1%) | Drug | XAF5 (concentration A: 0.1%) |
| XAF5 (concentration B: 0.035%) | Drug | XAF5 (concentration B: 0.035%) |
| Matching placebo | Drug | Placebo |
Primary outcome
LESS score (Clinician-Reported)
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
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.
Julie Roth, Ph.D. study director
Allergan
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing XAF5 (concentration A: 0.1%) and XAF5 (concentration B: 0.035%) in people with Steatoblepharon, run by Topokine Therapeutics, Inc. at 6 sites 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 3 inclusion and 5 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 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
LESS score (Clinician-Reported) (time frame: 16 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 Nov 2017.