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Efficacy of ACU-D1 in the Treatment of Acne Rosacea

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ClinicalTrials.gov Identifier: NCT03064438
Recruitment Status : Active, not recruiting
First Posted : February 27, 2017
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Accuitis, Inc.

Brief Summary:
The study evaluates the safety, efficacy and tolerability of ACCU-D1 when applied twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Two thirds of participants will receive ACCU-D1 while one third will receive vehicle control.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Rosacea

Arm Intervention/treatment
Experimental: ACCU-D1
ACCU-D1 applied to the face twice daily for 12 weeks.
Drug: ACCU-D1
ACCU-D1

Placebo Comparator: Vehicle Control
Vehicle applied to the face twice daily for 12 weeks.
Drug: Placebo Comparator
Placebo Comparator




Primary Outcome Measures :
  1. Total Inflammatory Lesion Count [ Time Frame: 12 weeks ]
    Efficacy as measure by total inflammatory lesion counts

  2. Investigator Global Assessment (IGA) [ Time Frame: 12 weeks ]
    Efficacy as measured by Investigator Global Assessment (IGA)

  3. CEA Score [ Time Frame: From baseline to 12 weeks ]
    Efficacy as measured by change in CEA score


Secondary Outcome Measures :
  1. 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).

  2. CEA Score [ Time Frame: Week 2,4,8, 12 and 14 ]
    Efficacy as measured by change from baseline in CEA score

  3. Responder Analysis [ Time Frame: Week 12 ]
    Efficacy as measure by percentage of patients achieving at least a 50% reduction from baseline inflammatory lesion count

  4. Total Inflammatory Lesion Count [ Time Frame: From Baseline to Week 12 ]
    Efficacy as measure by percent change in total inflammatory lesion count

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is male or non-pregnant female at least 18 years of age
  • Patient has ten to forty inflammatory lesions of rosacea on the face at Randomization
  • Clinical diagnosis of mild to severe facial rosacea as determined by Investigator's Global Assessment (IGA) at Randomization
  • A score of greater than moderate on the Clinical Erythema Assessment Scale
  • Informed consent obtained from subject and a copy of the signed consent provided to subject

Exclusion Criteria:

  • Patient is pregnant or planning to become pregnant
  • Patient is taking a topical or oral therapy which may affect the patient's rosacea

Information from the National Library of Medicine

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


Locations
United States, Kentucky
DS Research
Louisville, Kentucky, United States, 40421
United States, Texas
DermResearch
Austin, Texas, United States, 78759
Sponsors and Collaborators
Accuitis, Inc.

Responsible Party: Accuitis, Inc.
ClinicalTrials.gov Identifier: NCT03064438     History of Changes
Other Study ID Numbers: ACU-D1
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Rosacea
Skin Diseases