Skip to main content
OpenTrials
Completed

NCT Number: NCT03064438

Safety and Efficacy of ACU-D1 in the Treatment of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acne Rosacea Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

DS Research, Louisville, Kentucky, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACCU-D1

Drug

ACCU-D1

Vehicle

Drug

Placebo Comparator

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Accuitis, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2017
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.