Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03064438
Recruitment Status : Completed
First Posted : February 27, 2017
Results First Posted : August 23, 2021
Last Update Posted : August 23, 2021
Sponsor:
Information provided by (Responsible Party):
Accuitis, Inc.

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.

Condition or disease Intervention/treatment Phase
Acne Rosacea Drug: ACCU-D1 Drug: Vehicle Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 28, 2017
Actual Primary Completion Date : June 5, 2018
Actual Study Completion Date : June 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Acne Rosacea

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


  2. 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


  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.


Other Outcome Measures:
  1. 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


  2. 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064438


Locations
Layout table for location information
United States, Kentucky
DS Research
Louisville, Kentucky, United States, 40421
United States, Texas
DermResearch
Austin, Texas, United States, 78759
Sponsors and Collaborators
Accuitis, Inc.
  Study Documents (Full-Text)

Documents provided by Accuitis, Inc.:
Study Protocol  [PDF] August 5, 2017
Statistical Analysis Plan  [PDF] May 11, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Accuitis, Inc.
ClinicalTrials.gov Identifier: NCT03064438    
Other Study ID Numbers: ACU-D1
First Posted: February 27, 2017    Key Record Dates
Results First Posted: August 23, 2021
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Rosacea
Skin Diseases