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

Acne Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064438
• Other study ID #: ACU-D1
• Status: Completed
• Phase: Phase 2
• Start date: November 28, 2017
• Est. completion date: June 18, 2018

Study information

• Verified date: August 2021
• Source: Accuitis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 18, 2018
• Est. primary completion date: June 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Rosacea
• Rosacea

Intervention

Drug:
• ACCU-D1
ACCU-D1
• Vehicle
Placebo Comparator

Locations

Country	Name	City	State
United States	DermResearch	Austin	Texas
United States	DS Research	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Accuitis, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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