Safety and Efficacy of ACU-D1 in the Treatment of Acne Rosacea

August 17, 2021 updated by: Accuitis, Inc.

A RANDOMIZED, DOUBLE-BLIND, VEHICLE CONTROLLED, PROOF-OF CONCEPT STUDY OF THE SAFETY AND EFFICACY OF ACU-D1 OINTMENT IN SUBJECTS WITH ACNE ROSACEA

The study evaluated the safety, tolerability, and efficacy of ACCU-D1 when applied twice daily for 12 weeks in adult participants with moderate to severe acne rosacea. Two-third of the participants received ACCU-D1 while one-third of the participants received vehicle control.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40421
        • DS Research
    • Texas
      • Austin, Texas, United States, 78759
        • DermResearch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant is male or non-pregnant and non-lactating female at least 18 years of age
  • Participant has a clinical diagnosis of stable papulopustular rosacea (type-2)
  • Participant has a total of ≥10 and ≤40 inflammatory lesions (papules, pustules, and nodules) on the face
  • Participant has ≤2 nodules on the face
  • Participant has an investigator's global assessment (IGA) score of ≥3
  • If the participant is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control for the duration of the study
  • Participant is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of rosacea or which exposes the participant to an unacceptable risk by study participation
  • Participant is willing and able to follow all study instructions and to attend all study visits
  • Participant is able to comprehend and willing to sign an informed consent form

Exclusion Criteria:

  • Participant is pregnant, nursing, or planning to become pregnant during the duration of the study
  • Participant has used systemic glucocorticosteroids within 42 days prior to Visit 1 (inhaled and ocular glucocorticosteroids are permitted)
  • Participant has used systemic antibiotics within 28 days prior to Visit 1
  • Participant has used any topical glucocorticosteroids on the face within 28 days prior to Visit 1
  • Participant has used any prescription or over-the-counter product for the treatment of acne or rosacea within 14 days prior to Visit 1
  • Participant is currently using any therapy that, in the investigator's opinion, is a photosensitizer (for example, phenothiazines, amiodarone, quinine, thiazides, sulphonamides, quinolones, etc.)
  • Participant currently has any skin disease (for example, psoriasis, atopic dermatitis, eczema), or condition (for example, actinic keratosis, photo-damage, sunburn, excessive hair, open wounds) that, in the investigator's opinion, might impair evaluation of rosacea or which exposes the subject to an unacceptable risk by study participation

  • Participant currently has, on the face, or has had on the face, any of the following within the specified period prior to Visit 1 that, in the investigator's opinion, might impair evaluation of rosacea or which exposes the subject to an unacceptable risk by study participation:

    • A cutaneous malignancy; 180 days
    • Experienced a sunburn; 14 days
  • Participant has facial hair, that in the investigator's opinion, might impair evaluation of rosacea or proper study medication application
  • Participant has a history of sensitivity to any of the ingredients in the study medications
  • Participant has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ACU-D1 Ointment
Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
Drug: ACCU-D1
ACCU-D1
Placebo Comparator: ACU-D1 Ointment Vehicle
Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
Drug: Vehicle
Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Total Lesion Count at Week 12
Time Frame: Baseline, Week 12
Total lesion count was the sum of counts of the following lesion types (face only): Papule - raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material; Pustule - raised inflammatory lesions, <0.5 cm in diameter with visible purulent material; Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter.
Baseline, Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12
Time Frame: Baseline; Weeks 2, 4, 8, and 12

The IGA score is an ordered categorical value ranging from 0 (clear) to 4 (severe). A lower score indicated improvement in the condition.

Score 0 (clear): no papules or pustules, no nodules, none or barely perceptible erythema

Score 1 (near clear): very few (≤3) papules and/or pustules, no nodules, very mild erythema

Score 2 (mild): few papules and pustules present, no nodules, mild erythema

Score 3 (moderate): several papules and pustules are the predominant features, ≤2 nodules may be present, moderate erythema

Score 4 (severe): numerous papules and pustules, multiple nodules may be present, severe erythema
Baseline; Weeks 2, 4, 8, and 12
Percentage of Participants Who Were Treatment Responders at Week 12
Time Frame: Baseline, Week 12

Treatment responders were defined as participants who have either (1) 2 ordinal or more reductions in the IGA score from baseline or (2) an IGA score of 0 or 1.

The IGA score is an ordered categorical value ranging from 0 (clear) to 4 (severe). A lower score indicated improvement in the condition.

Score 0 (clear): no papules or pustules, no nodules, none or barely perceptible erythema

Score 1 (near clear): very few (≤3) papules and/or pustules, no nodules, very mild erythema

Score 2 (mild): few papules and pustules present, no nodules, mild erythema

Score 3 (moderate): several papules and pustules are the predominant features, ≤2 nodules may be present, moderate erythema

Score 4 (severe): numerous papules and pustules, multiple nodules may be present, severe erythema
Baseline, Week 12
Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12
Time Frame: Baseline; Weeks 2, 4, 8, and 12
Papule - raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material
Baseline; Weeks 2, 4, 8, and 12
Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12
Time Frame: Baseline; Weeks 2, 4, 8, and 12
Pustule - raised inflammatory lesions, <0.5 cm in diameter with visible purulent material
Baseline; Weeks 2, 4, 8, and 12
Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12
Time Frame: Baseline; Weeks 2, 4, 8, and 12
Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter
Baseline; Weeks 2, 4, 8, and 12
Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12
Time Frame: Baseline; Weeks 2, 4, 8, and 12
Papules + pustules lesions were the sum of counts of papule (raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material) and pustule (raised inflammatory lesions, <0.5 cm in diameter with visible purulent material) lesions.
Baseline; Weeks 2, 4, 8, and 12
Number of Participants With Adverse Events
Time Frame: Baseline to Week 14
Number of participants reporting any adverse event including local tolerability of signs and symptoms of irritation, clinical laboratory safety tests, and vital signs.
Baseline to Week 14

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12
Time Frame: Week 12

Erythema score was evaluated by the investigator on a 0 to 3 scale with a lower score indicating lesser severity.

Score 0 (clear): no erythema present

Score 1 (mild): slight erythema

Score 2 (moderate): definite erythema

Score 3 (severe): marked, fiery erythema
Week 12
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Time Frame: Day 1 (Post-application) and Weeks 2, 4, 8, and 14

Erythema score was evaluated by the investigator on a 0 to 3 scale with a lower score indicating lesser severity.

Score 0 (clear): no erythema present

Score 1 (mild): slight erythema

Score 2 (moderate): definite erythema

Score 3 (severe): marked, fiery erythema
Day 1 (Post-application) and Weeks 2, 4, 8, and 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Accuitis, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACU-D1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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