Efficacy of ACU-D1 in the Treatment of Acne Rosacea
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|ClinicalTrials.gov Identifier: NCT03064438|
Recruitment Status : Unknown
Verified April 2018 by Accuitis, Inc..
Recruitment status was: Active, not recruiting
First Posted : February 27, 2017
Last Update Posted : April 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acne Rosacea||Drug: ACCU-D1 Drug: Placebo Comparator||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy of ACU-D1 in the Treatment of Acne Rosacea|
|Actual Study Start Date :||November 28, 2017|
|Estimated Primary Completion Date :||July 15, 2018|
|Estimated Study Completion Date :||July 31, 2018|
ACCU-D1 applied to the face twice daily for 12 weeks.
Placebo Comparator: Vehicle Control
Vehicle applied to the face twice daily for 12 weeks.
Drug: Placebo Comparator
- Total Inflammatory Lesion Count [ Time Frame: 12 weeks ]Efficacy as measure by total inflammatory lesion counts
- Investigator Global Assessment (IGA) [ Time Frame: 12 weeks ]Efficacy as measured by Investigator Global Assessment (IGA)
- CEA Score [ Time Frame: From baseline to 12 weeks ]Efficacy as measured by change in CEA score
- Total Lesion Count [ Time Frame: Week 2, 4, 8, 12, and 14 ]Efficacy as measured by change from baseline in total lesion count (papules, pustules and nodules).
- CEA Score [ Time Frame: Week 2,4,8, 12 and 14 ]Efficacy as measured by change from baseline in CEA score
- Responder Analysis [ Time Frame: Week 12 ]Efficacy as measure by percentage of patients achieving at least a 50% reduction from baseline inflammatory lesion count
- Total Inflammatory Lesion Count [ Time Frame: From Baseline to Week 12 ]Efficacy as measure by percent change in total inflammatory lesion count
- Incidence of adverse events as a measure of safety and tolerability [ Time Frame: 12 weeks ]Incidence of adverse events as a measure of safety and tolerability
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): NCT03064438
|United States, Kentucky|
|Louisville, Kentucky, United States, 40421|
|United States, Texas|
|Austin, Texas, United States, 78759|