Clinical trial NCT03064438: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Rosacea
Lead sponsor: Accuitis, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Total Lesion Count at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12
timeFrame: Baseline; Weeks 2, 4, 8, and 12
measure: Percentage of Participants Who Were Treatment Responders at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12
timeFrame: Baseline; Weeks 2, 4, 8, and 12
measure: Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12
timeFrame: Baseline; Weeks 2, 4, 8, and 12
measure: Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12
timeFrame: Baseline; Weeks 2, 4, 8, and 12
measure: Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12
timeFrame: Baseline; Weeks 2, 4, 8, and 12
measure: Number of Participants With Adverse Events
timeFrame: Baseline to Week 14
Other outcomes:
measure: Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12
timeFrame: Week 12
measure: 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
timeFrame: Day 1 (Post-application) and Weeks 2, 4, 8, and 14
Locations:
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: Austin
country: United States
facility: DermResearch
state: Texas
Study officials:
References:
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.