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

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: Completed
• Conditions: Acne Rosacea
• Intervention / Treatment: Drug: ACCU-D1; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline; Weeks 2, 4, 8, and 12
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	Baseline, Week 12
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	Baseline; Weeks 2, 4, 8, and 12
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	Baseline; Weeks 2, 4, 8, and 12
Change From Baseline in Nodule Lesions at 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	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	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

Outcome Measure	Measure Description	Time Frame
Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at 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	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

• Sponsor: Accuitis, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2017
• Primary Completion (Actual): June 5, 2018
• Study Completion (Actual): June 18, 2018

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: February 24, 2017
• First Posted (Actual): February 27, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID 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