A Multicenter, Cohort-design, Double-blind, Randomized, Parallel-group, Controlled Study to Evaluate the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 395
- 试验地点
- 20
- 主要终点
- Percentage of Participants who Achieve a 20% Reduction in Acne Scar Area
研究概览
简要总结
Atrophic acne scars are flat, indented or with an inverted center scars that develop at the endpoint of the normal healing process for acne. Acne scarring that remains after acne resolves has a significant impact on health related quality of life, including reduced self-esteem and embarrassment/self consciousness. ELAPR002f provides an immediate space-occupying effect for filling in the scar tissue. The purpose of this study is to assess how safe and effective ELAPR002f injectable gel is on adult participants with atrophic acne scars.
ELAPR002f injectable gel is an investigational device being developed for the treatment of facial atrophic acne scars. There are 2 cohorts in this study. In Cohort 1, all participants will receive ELAPR002f injectable gel. In Cohort 2, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to the saline active control group. Around 395 adult participants with moderate to severe atrophic acne scarring on both cheeks will be screened in the study in approximately 25 sites in the United States.
Participants will receive 3 treatments over 2 months of intradermal injections of either ELAPR002f injectable gel or saline active control and will be followed for up to an additional 12 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants in general good health, and seeking improvement of atrophic acne scars.
- •Moderate to severe atrophic acne scarring (Grade 4 or 5 on the Allergan Acne Scar Improvement Scale [ASIS]) on each cheek based on evaluating investigator (EI) live assessment (both cheeks must qualify but do not need to have the same score) at the first Screening Visit.
- •At least 5 rolling or boxcar-type acne scars in total within the predefined 4 cm × 4 cm assessment field of either cheek in areas of otherwise normal healthy skin, as assessed by the treating investigator (TI).
排除标准
- •The participant has clinically significant acne on the face.
- •Current cutaneous or mucosal inflammatory or infectious processes other than acne (eg, herpes), rosacea, abscess, an unhealed wound, or a cancerous or precancerous lesion, on the face.
- •The participant presents with predominantly ice pick scars.
- •History of keloid scar formation, hypertrophic scarring, and/or post inflammatory hyperpigmentation or hypopigmentation.
研究组 & 干预措施
Cohort 1: Open-Label ELAPR002f Injectable Gel
Participants will receive ELAPR002f Injectable Gel on Days 1, 31, and 61. Participants will be followed for up to 420 days.
干预措施: ELAPR002f Injectable Gel (Device)
Cohort 2: ELAPR002f Injectable Gel
Participants will receive ELAPR002f Injectable Gel on Days 1, 31, and 61. Participants will be followed for up to 420 days.
干预措施: ELAPR002f Injectable Gel (Device)
Cohort 2: Saline Control
Participants will receive a saline control on Days 1, 31, and 61. Participants will be followed for up to 420 days.
干预措施: Saline Control (Device)
结局指标
主要结局
Percentage of Participants who Achieve a 20% Reduction in Acne Scar Area
时间窗: Baseline to Day 181
The acne scar area is calculated from 3D camera imaging software. Area is defined as the sum of the individual scar area of the 5 most prominent scars identified by the treating investigator (TI).
Number of Participants with Visual Disturbance Symptoms Associated with Vascular Occlusion
时间窗: Up to Day 420
Number of participants with any acute cognitive changes or any change in confrontational visual fields, ocular motility, or a worsening (1-line change or more) on the Snellen visual acuity assessment.
Number of Participants with Adverse Events
时间窗: Up to Day 420
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Number of Participants with Injection Site Responses (ISRs) and Systemic Responses
时间窗: Up to Day 420
Incidence of ISRs/systemic responses as recorded by e-diary. ISRs are defined as redness, pain after injection, tenderness to touch, firmness, swelling, lumps/bumps, bruising, itching and discoloration (not redness or bruising).
Number of Participants with Presence of Binding Antibodies
时间窗: Up to Day 420
Presence of binding antibodies followed by characterization through isotyping and evaluation of cross-reactivity to endogenous tissues.
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
时间窗: Up to Day 420
Vital sign parameters include body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate. The investigator will assess the results for clinical significance.
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
时间窗: Up to Day 420
Clinical laboratory parameters include tests of hematology, chemistry, and urinalysis. The investigator will assess the results for clinical significance.
Number of Participants With Clinically Significant Changes From Baseline in Physical Measurements
时间窗: Up to Day 420
Physical measurements include weight and BMI. The investigator will assess the results for clinical significance.
Change from Baseline Procedure Pain
时间窗: Up to Day 420
Participants will assess procedure pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) after each of the 3 treatment sessions.
Number of Participants with a Positive Skin Test
时间窗: Up to Day 420
Participants will undergo a skin test in the volar area of the forearm to test for hypersensitivity.
Number of Participants Needing a Histology of Volar Forearm Site Biopsy
时间窗: Up to Day 420
Participants who are suspected of having a hypersensitivity reaction or have a hypersensitivity reaction to the volar forearm injection site will require a punch biopsy of the volar forearm injection site.
次要结局
- Percentage of Participants who Achieve a 20% Reduction in Acne Scar Area(Up to Day 420)
- Percent Change from Baseline in Acne Scar Area(Up to Day 420)
- Percent Change from Baseline in Acne Scar Volume(Up to Day 420)
- Change from Baseline on the Overall Score of ACNE-Q Acne Scars Questionnaire(Up to Day 420)
- Change from Baseline on the Overall Score of ACNE-Q - Appearance-Related Distress(Up to Day 420)
- Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Total Score(Up to Day 420)
- Percentage of Participants Achieving "Responder" Status on Either Cheek Based on the Allergan Acne Scar Improvement Scale (ASIS), as assessed by the Evaluating Investigator(Up to Day 420)