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

Study Overview
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Brief Summary
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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.

Official Title
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A RANDOMIZED, DOUBLE-BLIND, VEHICLE CONTROLLED, PROOF-OF CONCEPT STUDY OF THE SAFETY AND EFFICACY OF ACU-D1 OINTMENT IN SUBJECTS WITH ACNE ROSACEA

Conditions
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Acne Rosacea

Intervention / Treatment
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* Drug: ACCU-D1
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACU-D1 Ointment<br>Twice-daily application of ACU-D1 ointment to the face for 12 weeks. | Drug: ACCU-D1<br>* ACCU-D1<br>|
| Placebo Comparator: ACU-D1 Ointment Vehicle<br>Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. | Drug: Vehicle<br>* Placebo Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |