NCT03064438已完成2 期
A RANDOMIZED, DOUBLE-BLIND, VEHICLE CONTROLLED, PROOF-OF CONCEPT STUDY OF THE SAFETY AND EFFICACY OF ACU-D1 OINTMENT IN SUBJECTS WITH ACNE ROSACEA
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change From Baseline in Total Lesion Count at Week 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ACU-D1 Ointment
Experimental
Twice-daily application of ACU-D1 ointment to the face for 12 weeks.
干预措施: ACCU-D1 (Drug)
ACU-D1 Ointment Vehicle
Placebo Comparator
Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks.
干预措施: Vehicle (Drug)
结局指标
主要结局
Change From Baseline in Total Lesion Count at Week 12
时间窗: 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.
次要结局
- Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12(Baseline; Weeks 2, 4, 8, and 12)
- Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12(Baseline; Weeks 2, 4, 8, and 12)
- Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12(Baseline; Weeks 2, 4, 8, and 12)
- Percentage of Participants Who Were Treatment Responders at Week 12(Baseline, Week 12)
- Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12(Baseline; Weeks 2, 4, 8, and 12)
- Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12(Baseline; Weeks 2, 4, 8, and 12)
- Number of Participants With Adverse Events(Baseline to Week 14)
研究者
研究点 (2)
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