Lower Eyelid Steatoblepharon (Excess Eyelid Fat)
Conditions
Keywords
steatoblepharon, blepharoptosis, dermatochalasis, blepharoplasty, periorbital, orbital, eyelid, eyebags, eye bags
Brief 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).
Interventions
DRUGXOPH5 Ointment
DRUGPlacebo
Sponsors
Topokine Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
(abbreviated): * 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
Exclusion criteria
(abbreviated): * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported | 11 weeks | Photonumeric scale, range 0-4, 0 is absence of steatoblepharon, 4 is very severe steatoblepharon. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Scale 1 (PSS1) | 0-11 weeks | 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. |
| Patient Satisfaction Scale 2 (PSS2) | 11 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| XOPH5 Ointment XOPH5 Ointment is the investigational drug to be studied.
XOPH5 Ointment | 60 |
| Placebo Ointment Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.
Placebo | 30 |
| Total | 90 |
Baseline characteristics
| Characteristic | XOPH5 Ointment | Placebo Ointment | Total |
|---|---|---|---|
| Age, Continuous | 54.2 years STANDARD_DEVIATION 7.4 | 55.1 years STANDARD_DEVIATION 7.5 | 54.5 years STANDARD_DEVIATION 7.4 |
| Sex: Female, Male Female | 40 Participants | 17 Participants | 57 Participants |
| Sex: Female, Male Male | 20 Participants | 13 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 60 | 0 / 30 |
| serious Total, serious adverse events | 0 / 60 | 1 / 30 |
Outcome results
Primary
Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported
Photonumeric scale, range 0-4, 0 is absence of steatoblepharon, 4 is very severe steatoblepharon.
Time frame: 11 weeks
Population: intention-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XOPH5 Ointment | Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported | 27 participants |
| Placebo Ointment | Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported | 6 participants |
p-value: 0.02Chi-squared
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.
Time frame: 0-11 weeks
Population: intention-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XOPH5 Ointment | Patient Satisfaction Scale 1 (PSS1) | 17.9 units on a scale | Standard Deviation 14.4 |
| Placebo Ointment | Patient Satisfaction Scale 1 (PSS1) | 7.3 units on a scale | Standard Deviation 13 |
p-value: 0.001t-test, 2 sided
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.
Time frame: 11 weeks
Population: intention-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XOPH5 Ointment | Patient Satisfaction Scale 2 (PSS2) | 16.3 units on a scale | Standard Deviation 3.3 |
| Placebo Ointment | Patient Satisfaction Scale 2 (PSS2) | 14.0 units on a scale | Standard Deviation 3 |
p-value: 0.002t-test, 2 sided