An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema
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|ClinicalTrials.gov Identifier: NCT01933464|
Recruitment Status : Unknown
Verified August 2013 by Anna Di Nardo, MD, PhD, University of California, San Diego.
Recruitment status was: Recruiting
First Posted : September 2, 2013
Last Update Posted : September 2, 2013
|Condition or disease||Intervention/treatment||Phase|
|Papulopustular Rosacea||Drug: Cromolyn Sodium Drug: Normal Saline||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||February 2014|
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%.
Drug: Cromolyn Sodium
Other Name: Crolom
Placebo Comparator: 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.
Drug: Normal Saline
- Facial erythema [ Time Frame: Baseline ]Facial erythema will be measured using the Clinician's Erythema Assessment 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
- Change in facial erythema [ Time Frame: 8 weeks ]We will measure participants' change in facial erythema over the course of the study.
- Matrix Metalloproteinase levels [ Time Frame: Baseline ]Tape stripping methods will be used to determine matrix metalloproteinase levels
- Change in matrix metalloproteinase levels [ Time Frame: 8 weeks ]We will compare subjects' matrix metalloproteinase levels at the beginning of the study (baseline) to those at the end of the study (8 weeks after baseline)
- Adverse events [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933464
|Contact: Aimee Two, MDemail@example.com|
|United States, California|
|UCSD Division of Dermatology||Recruiting|
|San Diego, California, United States, 92122|
|Contact: Aimee Two, MD 858-657-8390 firstname.lastname@example.org|
|Principal Investigator: Anna Di Nardo, MD, PhD|