Trial · NCT01933464
An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema
NCT01933464, Phase 1, Phase 2, Completed, University of California, San Diego; results first posted 2019-07-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema. Trials, record NCT01933464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01933464
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema
- NCT number
- NCT01933464
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- University of California, San Diego
- Conditions
- Papulopustular Rosacea
- Interventions
- Cromolyn Sodium, Normal Saline
- First posted
- 2013-09-02
- Last updated
- 2019-08-07
- Results first posted
- 2019-07-30
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Facial Erythema | Baseline | 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. |
| Primary | Change in Facial Erythema | Baseline and 8 weeks | We 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. |
| Secondary | Matrix Metalloproteinase Activity Levels | 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). |
| Secondary | Change in Matrix Metalloproteinase Activity | Baseline and 8 weeks | We 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). |
| Other | Adverse Events | Baseline, and then 3, 6 and 8 weeks after beginning study intervention | Adverse events will be recorded at each visit and their likelihood to the study interventions will be recorded |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Facial Erythema | Baseline | score on a scale | MEAN | |
| PRIMARY | Change in Facial Erythema | Baseline and 8 weeks | score on a scale | MEAN | |
| SECONDARY | Matrix Metalloproteinase Activity Levels | Baseline | Vmax/sec | MEDIAN | |
| SECONDARY | Change in Matrix Metalloproteinase Activity | Baseline and 8 weeks | Vmax/sec | MEDIAN | |
| OTHER_PRE_SPECIFIED | Adverse Events | Baseline, and then 3, 6 and 8 weeks after beginning study intervention |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Facial Erythema | Cromolyn | 6.6 | Standard Deviation 1.9 | score on a scale | |
| Facial Erythema | Vehicle | 6 | Standard Deviation 1.4 | score on a scale | |
| Change in Facial Erythema | Cromolyn | -1.6 | Standard Deviation 2.6 | score on a scale | |
| Change in Facial Erythema | Vehicle | -0.8 | Standard Deviation 2.8 | score on a scale | |
| Matrix Metalloproteinase Activity Levels | Cromolyn | 0.02 | Inter-Quartile Range 0.0135 to 0.03 | Vmax/sec | |
| Matrix Metalloproteinase Activity Levels | Vehicle | 0.02 | Inter-Quartile Range 0.013 to 0.025 | Vmax/sec | |
| Change in Matrix Metalloproteinase Activity | Cromolyn | -0.005 | Inter-Quartile Range -0.006 to 0 | Vmax/sec | |
| Change in Matrix Metalloproteinase Activity | Vehicle | 0.005 | Inter-Quartile Range 0.004 to 0.008 | Vmax/sec |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cromolyn | 5 | |
| Overall Study | STARTED | Vehicle | 5 | |
| Overall Study | COMPLETED | Cromolyn | 5 | |
| Overall Study | COMPLETED | Vehicle | 5 | |
| Overall Study | NOT COMPLETED | Cromolyn | 0 | |
| Overall Study | NOT COMPLETED | Vehicle | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cromolyn | ||
| Total, all-cause mortality | Vehicle | ||
| Total, other adverse events | Cromolyn | 0 | 5 |
| Total, other adverse events | Vehicle | 0 | 5 |
| Total, serious adverse events | Cromolyn | 0 | 5 |
| Total, serious adverse events | Vehicle | 0 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cromolyn vs Vehicle: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01933464
GET https://conductscience.org/api/trials/v1/NCT01933464/registered