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NCT01933464 · ClinicalTrials.gov registry record · Phase 1
An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema
A Phase 1 study of Papulopustular Rosacea, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT01933464: Completed Phase 1 study of Papulopustular Rosacea, sponsored by University of California, San Diego.
NCT01933464 is a Phase 1 study of Papulopustular Rosacea that has completed, run by University of California, San Diego. The registered enrollment target is 10 participants, below the 279-participant average among 11 other Papulopustular Rosacea trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01933464, a Phase 1 study of Papulopustular Rosacea, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to investigate whether topical application of a cromolyn sodium solution is able to decrease the facial redness seen in patients with papulopustular rosacea. Previous work in the lab of Dr. Di Nardo on mice has suggested that cromolyn may be able to have this effect. The study will enroll a total of 10 patients. 5 will randomly be assigned to receive the cromolyn sodium solution, and the other 5 will be randomly assigned to receive the placebo solution. All participants will be instructed to apply their assigned solution twice daily to their face. Patients will return to the clinic 3, 6, and 8 weeks after the distribution of the solutions to measure the efficacy of their assigned solution.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Normal Saline
- DRUG Cromolyn Sodium
Study Locations (1)
California
- UCSD Division of Dermatology - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
What the finished NCT01933464 record still lists
NCT01933464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 279-participant average among 11 other Papulopustular Rosacea trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Papulopustular Rosacea appearing as the primary indexed condition, and to 2 interventions - of which Normal Saline is the first listed.
NCT01933464 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01933464 about?
NCT01933464 is a clinical study titled "An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema". This study is designed to investigate whether topical application of a cromolyn sodium solution is able to decrease the facial redness seen in patients with papulopustular rosacea. Previous work in the lab of Dr. Di Nardo on mice has suggested that cromolyn may be able to have this effect. The study...
What is the current status of trial NCT01933464?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2013-08. Estimated completion is 2014-04.
What conditions does trial NCT01933464 study?
This clinical trial studies the following conditions: Papulopustular Rosacea.
What interventions are being tested in trial NCT01933464?
The interventions under investigation include: Normal Saline (DRUG), Cromolyn Sodium (DRUG).
Who is sponsoring clinical trial NCT01933464?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01933464 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01933464's enrollment target sits among peer trials
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Each bar is a band; taller bars hold more other Papulopustular Rosacea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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