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

Primary Purpose

Acne Rosacea

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ACCU-D1
Vehicle
Sponsored by
Accuitis, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DS Research
  • DermResearch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ACU-D1 Ointment

ACU-D1 Ointment Vehicle

Arm Description

Twice-daily application of ACU-D1 ointment to the face for 12 weeks.

Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in Total Lesion Count at 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.

Secondary Outcome Measures

Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at 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
Percentage of Participants Who Were Treatment Responders at 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
Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12
Papule - raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material
Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12
Pustule - raised inflammatory lesions, <0.5 cm in diameter with visible purulent material
Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12
Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter
Change From Baseline in Papules + Pustules Lesions at 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.
Number of Participants With Adverse Events
Number of participants reporting any adverse event including local tolerability of signs and symptoms of irritation, clinical laboratory safety tests, and vital signs.

Full Information

First Posted
February 22, 2017
Last Updated
August 17, 2021
Sponsor
Accuitis, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03064438
Brief Title
Safety and Efficacy of ACU-D1 in the Treatment of Acne Rosacea
Official Title
A RANDOMIZED, DOUBLE-BLIND, VEHICLE CONTROLLED, PROOF-OF CONCEPT STUDY OF THE SAFETY AND EFFICACY OF ACU-D1 OINTMENT IN SUBJECTS WITH ACNE ROSACEA
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
June 5, 2018 (Actual)
Study Completion Date
June 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Accuitis, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Rosacea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACU-D1 Ointment
Arm Type
Experimental
Arm Description
Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
Arm Title
ACU-D1 Ointment Vehicle
Arm Type
Placebo Comparator
Arm Description
Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
ACCU-D1
Intervention Description
ACCU-D1
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Placebo Comparator
Primary Outcome Measure Information:
Title
Change From Baseline in Total Lesion Count at Week 12
Description
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.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12
Description
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
Time Frame
Baseline; Weeks 2, 4, 8, and 12
Title
Percentage of Participants Who Were Treatment Responders at Week 12
Description
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
Time Frame
Baseline, Week 12
Title
Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12
Description
Papule - raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material
Time Frame
Baseline; Weeks 2, 4, 8, and 12
Title
Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12
Description
Pustule - raised inflammatory lesions, <0.5 cm in diameter with visible purulent material
Time Frame
Baseline; Weeks 2, 4, 8, and 12
Title
Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12
Description
Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter
Time Frame
Baseline; Weeks 2, 4, 8, and 12
Title
Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12
Description
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.
Time Frame
Baseline; Weeks 2, 4, 8, and 12
Title
Number of Participants With Adverse Events
Description
Number of participants reporting any adverse event including local tolerability of signs and symptoms of irritation, clinical laboratory safety tests, and vital signs.
Time Frame
Baseline to Week 14
Other Pre-specified Outcome Measures:
Title
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12
Description
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
Time Frame
Week 12
Title
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
Description
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
Time Frame
Day 1 (Post-application) and Weeks 2, 4, 8, and 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
DS Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40421
Country
United States
Facility Name
DermResearch
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34076401
Citation
Jackson JM, Coulon R, Arbiser JL. Evaluation of a First-in-Class Proteasome Inhibitor in Patients With Moderate to Severe Rosacea. J Drugs Dermatol. 2021 Jun 1;20(6):660-664. doi: 10.36849/JDD.2021.5925.
Results Reference
derived

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

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