Rosacea Clinical Trial
Official title:
Epidermal Permeability Barrier Function and Stratum Corneum Hydration of Rosacea Following Application of Ivermectin
The primary hypothesis is that weekly digital interactions and routine measurement of TEWL rates and SC hydration levels will promote patient adherence to maintenance ivermectin therapy and prevent disease relapse. The project will consist of a trial in which thirty subjects with rosacea receive ivermectin therapy and are randomized to receive either no intervention, a weekly digital survey to assess patient's attitudes towards ivermectin therapy, or a portal hydration measurement device that measures TEWL rates and SC hydration levels. The study team will measure adherence objectively in all groups with electronic monitors attached to the containers of the ivermectin, which all subjects will be told to use daily for maintenance therapy. Additionally, the hydration measurement device can transmit data to an Internet server via a smartphone using Bluetooth technology, thereby allowing providers to monitor a patient's TEWL rate and SC levels.
Subjects will be offered an opportunity to participate in the study. Subjects will either have a diagnosis of rosacea. A total of 30 subjects will be enrolled. After consent and basic demographics, a study team member will use the GPSkin Barrier® to measure the baseline moisture level of the face of all subjects. Subjects will also fill out questionnaires pertaining to quality of life, accountability, and severity of rosacea. Subjects will be randomized into one of three arms: the control group (n= 10), the digital interaction group (n=10), or the GPSkin group (n=10). All subjects will receive ivermectin equipped with an electronic monitor to measure adherence for daily treatment of rosacea. The digital interaction group will receive a survey by email each week asking about their use ivermectin generated by Causa Research. The subjects in the GPSkin group will receive the GPSkin Barrier® to measure their moisture level of their face daily. Subjects will be instructed to use the ivermectin once daily. Subjects will return at 3 Months. At this visit, the data from the electronic adherence monitoring will be downloaded, the ivermectin will be weighed, and the subject will fill out the same questionnaires (quality of life, accountability, and severity of rosacea). The intervention subjects will be evaluated on their use of the GPSkin Barrier® to measure their stratum corneum hydration. Subjects not randomized to the email intervention group will receive an accountability questionnaire at the beginning and end of the study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05597462 -
Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks
|
Phase 1 | |
| Completed |
NCT02601963 -
Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea
|
Phase 2 | |
| Completed |
NCT02249065 -
Mirvaso in Use Study
|
Phase 4 | |
| Completed |
NCT02292797 -
Assessment of the Rosacea Prevalence in the General Population
|
N/A | |
| Completed |
NCT01659853 -
Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
|
Phase 3 | |
| Completed |
NCT01426269 -
Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo
|
Phase 4 | |
| Completed |
NCT00991198 -
The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage
|
Phase 2 | |
| Terminated |
NCT04336163 -
Skin Imaging to Inform Laser Treatments
|
N/A | |
| Recruiting |
NCT04108897 -
Analysis of the Microbiome in Rosacea
|
Early Phase 1 | |
| Completed |
NCT03872050 -
Deep Phenotyping of Rosacea and Migraine
|
||
| Recruiting |
NCT06033352 -
Potassium-titanyl Phosphate (KTP) Laser vs KTP Laser and Ivermectin Cream for Facial Rosacea
|
Phase 2 | |
| Completed |
NCT03263273 -
Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea
|
Phase 2 | |
| Completed |
NCT04508205 -
CGB-400 for the Reduction of Facial Redness and Bumps and Blemishes
|
Phase 1 | |
| Completed |
NCT04508660 -
CGB-400 for the Reduction of Facial Redness
|
Phase 1 | |
| Completed |
NCT05094700 -
A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants
|
N/A | |
| Active, not recruiting |
NCT03211585 -
EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA
|
N/A | |
| Completed |
NCT02576847 -
Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel
|
Phase 3 | |
| Completed |
NCT02637232 -
Mirvaso® Utilisation and Patient Satisfaction Evaluation (MUSE)
|
||
| Completed |
NCT02576860 -
Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
|
Phase 3 | |
| Completed |
NCT02583009 -
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Rosacea
|
Phase 2 |