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

NCT03064438 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ACU-D1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Acne Rosacea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12

  Baseline; Weeks 2, 4, 8, and 12

• Percentage of Participants Who Were Treatment Responders at Week 12

  Baseline, Week 12

• Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12

  Baseline; Weeks 2, 4, 8, and 12

• Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12

  Baseline; Weeks 2, 4, 8, and 12

• Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12

  Baseline; Weeks 2, 4, 8, and 12

Other Outcomes (2)

• Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12

  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

  Day 1 (Post-application) and Weeks 2, 4, 8, and 14

Study Arms (2)

ACU-D1 Ointment

EXPERIMENTAL

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

Drug: ACCU-D1

ACU-D1 Ointment Vehicle

PLACEBO COMPARATOR

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

Drug: Vehicle

Interventions

ACCU-D1 DRUG

ACCU-D1

ACU-D1 Ointment

Vehicle DRUG

Placebo Comparator

ACU-D1 Ointment Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Accuitis, Inc.: lead

Study Sites (2)

DS Research

Louisville, Kentucky, 40421, United States

Location

DermResearch

Austin, Texas, 78759, United States

Location

Related Publications (1)

• 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.

  PMID: 34076401 DERIVED

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Chief Science Officer
• Organization: Accuitis, Inc.

info@accuitis.com

678-812-1492

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: February 27, 2017
• Study Start: November 28, 2017
• Primary Completion: June 5, 2018
• Study Completion: June 18, 2018
• Last Updated: August 23, 2021
• Results First Posted: August 23, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)