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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XOPH5 Ointment | Experimental | XOPH5 Ointment is the investigational drug to be studied. |
|
| Placebo Ointment | Placebo Comparator | Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XOPH5 Ointment | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported | Photonumeric scale, range 0-4, 0 is absence of steatoblepharon, 4 is very severe steatoblepharon. | 11 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Scale 1 (PSS1) | Change from Baseline to Week 11 in PSS1 score. PSS1 scale items use an ordinal scale with range 0-10, where 0 is the least favorable and 10 is the most favorable. The composite score is the sum of 6 items and has a possible response range of 0 to 60. | 0-11 weeks |
| Patient Satisfaction Scale 2 (PSS2) |
Inclusion Criteria (abbreviated):
Exclusion Criteria (abbreviated):
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| Name | Affiliation | Role |
|---|---|---|
| Michael S. Singer, MD, PhD | Topokine Therapeutics, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Topokine Therapeutics Clinical Study Centers | Boston | Massachusetts | 02111 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | XOPH5 Ointment | XOPH5 Ointment is the investigational drug to be studied. XOPH5 Ointment |
| FG001 | Placebo Ointment | Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient. Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | XOPH5 Ointment | XOPH5 Ointment is the investigational drug to be studied. XOPH5 Ointment |
| BG001 | Placebo Ointment | Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient. Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported | Photonumeric scale, range 0-4, 0 is absence of steatoblepharon, 4 is very severe steatoblepharon. | intention-to-treat | Posted | Number | participants | 11 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | XOPH5 Ointment | XOPH5 Ointment is the investigational drug to be studied. XOPH5 Ointment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Guillan-Barre syndrome | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperemia eyelid (mild, transient) | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Scientific Officer | Topokine Therapeutics, Inc. | 617 203 2034 | CSO@topokine.com |
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| ID | Term |
|---|---|
| D001763 | Blepharoptosis |
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
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|
Composite score on PSS2 scale. PSS2 is an ordinal scale with range 1-7, where 1 is least favorable and 7 is most favorable. The composite score is the sum of 3 items and has a possible response range of 3 to 21. |
| 11 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Other Pre-specified | Patient Satisfaction Scale 1 (PSS1) | Change from Baseline to Week 11 in PSS1 score. PSS1 scale items use an ordinal scale with range 0-10, where 0 is the least favorable and 10 is the most favorable. The composite score is the sum of 6 items and has a possible response range of 0 to 60. | intention-to-treat | Posted | Mean | Standard Deviation | units on a scale | 0-11 weeks |
|
|
|
|
| Other Pre-specified | Patient Satisfaction Scale 2 (PSS2) | Composite score on PSS2 scale. PSS2 is an ordinal scale with range 1-7, where 1 is least favorable and 7 is most favorable. The composite score is the sum of 3 items and has a possible response range of 3 to 21. | intention-to-treat | Posted | Mean | Standard Deviation | units on a scale | 11 weeks |
|
|
|
|
| 0 |
| 60 |
| 11 |
| 60 |
| EG001 | Placebo Ointment | Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient. Placebo | 1 | 30 | 0 | 30 |
| Increase in vellus hair (mild) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |