Trial Outcomes & Findings for An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema (NCT NCT01933464)
NCT ID: NCT01933464
Last Updated: 2019-08-07
Results Overview
Facial erythema will be measured using the Clinician's Erythema Assessment(CEA) applied to 5 areas of the subject's face (chin, nose, glabella, left cheek, right cheek), as well as using measurements from a colorimeter applied to each of the 5 locations previous mentioned. Each area is rated from 0-4, where 4 represents the most facial erythema (worst outcome). The scores for the 5 locations are summed with a CEA total score scale of 0-20.
COMPLETED
PHASE1/PHASE2
10 participants
Baseline
2019-08-07
Participant Flow
Participant milestones
| Measure |
Cromolyn
Subjects in this arm will be asked to apply their assigned medication twice daily to their entire face. The medication they will be receiving is cromolyn sodium ophthalmic solution, 4%.
Cromolyn Sodium
|
Vehicle
Participants in this group will be assigned a solution consisting of only the inactive ingredients in cromolyn sodium ophthalmic solution to apply to their entire face twice daily.
Normal Saline
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema
Baseline characteristics by cohort
| Measure |
Cromolyn
n=5 Participants
Subjects in this arm will be asked to apply their assigned medication twice daily to their entire face. The medication they will be receiving is cromolyn sodium ophthalmic solution, 4%.
Cromolyn Sodium
|
Vehicle
n=5 Participants
Participants in this group will be assigned a solution consisting of only the inactive ingredients in cromolyn sodium ophthalmic solution to apply to their entire face twice daily.
Normal Saline
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 5.2 • n=99 Participants
|
62.6 years
STANDARD_DEVIATION 9.9 • n=107 Participants
|
62.4 years
STANDARD_DEVIATION 7.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: BaselineFacial erythema will be measured using the Clinician's Erythema Assessment(CEA) applied to 5 areas of the subject's face (chin, nose, glabella, left cheek, right cheek), as well as using measurements from a colorimeter applied to each of the 5 locations previous mentioned. Each area is rated from 0-4, where 4 represents the most facial erythema (worst outcome). The scores for the 5 locations are summed with a CEA total score scale of 0-20.
Outcome measures
| Measure |
Cromolyn
n=5 Participants
Subjects in this arm will be asked to apply their assigned medication twice daily to their entire face. The medication they will be receiving is cromolyn sodium ophthalmic solution, 4%.
Cromolyn Sodium
|
Vehicle
n=5 Participants
Participants in this group will be assigned a solution consisting of only the inactive ingredients in cromolyn sodium ophthalmic solution to apply to their entire face twice daily.
Normal Saline
|
|---|---|---|
|
Facial Erythema
|
6.6 score on a scale
Standard Deviation 1.9
|
6 score on a scale
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksWe will measure participants' change in facial erythema over the course of the study. The change in facial erythema is measured as a difference between the final (8 weeks after baseline) and baseline visit of the sum of the CEA scores determined from the 5 designated locations (nose, glabella, left cheek, right cheek, and chin). The scale range from -20 to 20. A negative score indicates improvement of facial erythema from baseline to 8 weeks after baseline. A positive score indicates worsening of facial erythema from baseline to 8 weeks after baseline.
Outcome measures
| Measure |
Cromolyn
n=5 Participants
Subjects in this arm will be asked to apply their assigned medication twice daily to their entire face. The medication they will be receiving is cromolyn sodium ophthalmic solution, 4%.
Cromolyn Sodium
|
Vehicle
n=5 Participants
Participants in this group will be assigned a solution consisting of only the inactive ingredients in cromolyn sodium ophthalmic solution to apply to their entire face twice daily.
Normal Saline
|
|---|---|---|
|
Change in Facial Erythema
|
-1.6 score on a scale
Standard Deviation 2.6
|
-0.8 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: BaselineTape stripping methods were used to isolate matrix metalloproteinase(MMP). Total-MMP activity was determined with total-MMP fluorogenic substrate (5 μM; Enzo Life Sciences), in protein extracts, and subsequently measuring activity (Vmax/sec) at a fluorescence excitation wavelength 328 nm and an emission wavelength of 400 nm in a fluorescence plate reader (Gemini EM microplate spectrofluorometer).
Outcome measures
| Measure |
Cromolyn
n=5 Participants
Subjects in this arm will be asked to apply their assigned medication twice daily to their entire face. The medication they will be receiving is cromolyn sodium ophthalmic solution, 4%.
Cromolyn Sodium
|
Vehicle
n=5 Participants
Participants in this group will be assigned a solution consisting of only the inactive ingredients in cromolyn sodium ophthalmic solution to apply to their entire face twice daily.
Normal Saline
|
|---|---|---|
|
Matrix Metalloproteinase Activity Levels
|
0.02 Vmax/sec
Interval 0.0135 to 0.03
|
0.02 Vmax/sec
Interval 0.013 to 0.025
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksWe will compare subjects' matrix metalloproteinase activity levels at the beginning of the study (baseline) to those at the end of the study (8 weeks after baseline). Tape stripping methods were used to isolate matrix metalloproteinase(MMP). Total-MMP activity was determined with total-MMP fluorogenic substrate (5 μM; Enzo Life Sciences), in protein extracts, and subsequently measuring activity (Vmax/sec) at a fluorescence excitation wavelength 328 nm and an emission wavelength of 400 nm in a fluorescence plate reader (Gemini EM microplate spectrofluorometer).
Outcome measures
| Measure |
Cromolyn
n=5 Participants
Subjects in this arm will be asked to apply their assigned medication twice daily to their entire face. The medication they will be receiving is cromolyn sodium ophthalmic solution, 4%.
Cromolyn Sodium
|
Vehicle
n=5 Participants
Participants in this group will be assigned a solution consisting of only the inactive ingredients in cromolyn sodium ophthalmic solution to apply to their entire face twice daily.
Normal Saline
|
|---|---|---|
|
Change in Matrix Metalloproteinase Activity
|
-0.005 Vmax/sec
Interval -0.006 to 0.0
|
0.005 Vmax/sec
Interval 0.004 to 0.008
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, and then 3, 6 and 8 weeks after beginning study interventionAdverse events will be recorded at each visit and their likelihood to the study interventions will be recorded
Outcome measures
Outcome data not reported
Adverse Events
Cromolyn
Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dermatology Clinical Trial Manager
UCSD Dermatology Clincal Trials
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place