Non-interventional Translational Study in Mild, Moderate and Severe Acne Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Acne lesion counts
研究概览
简要总结
This study aims to uncover the specific immunopathology, microbiome and pathophysiology of acne vulgaris in people living in a tropical climate such as Singapore. This is a largely unexplored population in terms of acne pathogenesis, and will lead to population-specific interventions for the management of acne vulgaris.
详细描述
The main objective of this translational study in healthy participants and in mild, moderate and severe acne participants is to deepen the current understanding of acne aetiology. A multi-omics approach will be leveraged to analyse the interactions between the local skin microbiota and host factors found in different stages of acne vulgaris and generate hypotheses on how these may contribute to different disease manifestations.
General objectives:
I. Deepen the current understanding of acne aetiology II. Identify key biological markers of disease severity and specific immune pathways III. Describe bacterial components associated with disease severity and inflammatory immune response IV. Determine antigens of the natural immune response against C. acnes
Data collected from participants includes:
- Demographic Data [age, sex, ethnicity, body mass index (BMI)]
- Skin type (using the Fitzpatrick skin classification scale)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •AGE I01: Aged 18 to 25 years on the day of inclusion.
- •TYPE OF PARTICIPANT AND DISEASE CHARACTERISTICS
- •I02: Participants with a formal diagnosis of either:
- •Mild facial acne vulgaris defined as Investigator's Global Assessment (IGA) of 2, or
- •Moderate facial acne vulgaris defined as IGA score of 3, or
- •Severe facial acne vulgaris defined as IGA score of 4, or
- •Healthy volunteers without acne defined as IGA score of
- •INFORMED CONSENT I03: Informed consent form has been signed and dated by participant capable of providing informed consent.
- •Note: For minor participants, informed consent form must also be signed and dated by the parent(s) or another legally acceptable representative(s).
- •OTHER INCLUSIONS I04: Participant or participant and parent(s)/legally acceptable representative(s) are able to attend all scheduled visits and to comply with all study procedures.
排除标准
- •Participants are not eligible for the study if any of the following criteria are met:
- •MEDICAL CONDITIONS E01: Thrombocytopenia, presence of bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating blood sampling, currently or previously suffering from any immune disorder.
- •E02: Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion.
- •E03: Active nodulocystic acne, acne conglobata, acne fulminans, secondary acne (eg, chloracne, drug-induced acne) or other forms of acne (eg, acne mechanica).
- •E04: Skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the study intervention or requires use of interfering topical, systemic, or surgical therapy.
- •E05: Excessive facial hair, facial tattoos, facial skin disorders, skin reactions that may interfere with the study assessments in the investigator's opinion (including - but not limited to - actinic keratosis, eczema, psoriasis, seborrheic dermatitis, rosacea, acute or recent sunburn) or skin infection.
- •E06: Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion.
- •E07: Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
- •E08: Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of samplings. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- •PRIOR/CONCOMITANT THERAPY:
- •E09: Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within 6 months prior to the study sample collection; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) within 3 months from study sample collection.
- •E10: Start or switch of hormonal contraceptive use within 12 weeks prior to the study visit.
- •E11: Previous use of oral isotretinoin. E12: Use of any acne-affecting treatment without an appropriate washout period (antibacterial/antifungal/antiseptic medications or topicals). Participants receiving prohibited medications/therapies at Screening Visit will have to observe a washout period of 2 to 24 weeks before enrolment to preserve eligibility in the study.
- •E13: Previous vaccination against C. acnes with an investigational vaccine E14: Receipt of immune globulins, blood or blood-derived products in the past 3 months E15: Pregnant or lactating women
- •PRIOR/CONCURRENT CLINICAL STUDY EXPERIENCE E16: Participation at the time of study enrolment or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- •OTHER EXCLUSIONS:
- •E17: Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- •E18 Identified as an Investigator or employee of the Investigator or study centre with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
研究组 & 干预措施
Mild Acne
Moderate Acne
Severe Acne
Healthy Participants
结局指标
主要结局
Acne lesion counts
时间窗: 2 years
The number of total lesions, inflammatory lesions (papules and pustules), and non-inflammatory lesions (open and closed comedones) on the face will be counted. All lesions on the face should be counted, including those on the nose. Counts of nodulocystic lesion (nodules and cysts) will be reported separately and are not to be included in the inflammatory or non-inflammatory lesion counts.
Investigator's Global Assessment (IGA) Scale
时间窗: 2 years
The overall severity of facial acne will be assessed using the 5-point IGA scale (Table 6) (15). Each grade is defined by a distinct and clinically relevant morphologic description that minimizes interobserver variability. The IGA severity score assessments should be performed exclusively by site staff qualified as IGA rater. Investigators or designee should use the IGA scale provided in the study protocol throughout the study.
Patient Reported Outcome Measures
时间窗: 2 years
With the objective of evaluating the impact of different acne severities in the quality of life, participants will be asked to complete 2 quality of life (QoL) questionnaires: the Skindex-29 and the Acne-specific Quality of Life (Acne-QoL). The Skindex-29 questionnaire is a validated health-related quality of life self-administered questionnaire to assess the impact of skin diseases on patient's quality of life (17). Skindex-29 consists of 30 items, distributed into 3 domains (symptoms, emotion and function. Each item is scored on a 5-point Likert scale, from 1 to 5. Scores are standardized to 100, with lower score indicating higher levels of QoL. The Acne-QoL is a validated health-related quality of life self-administered questionnaire to assess quality of life among participants with facial acne (16). Acne-QoL consists of 19 items organized into 4 domains: self-perception, role-social, role-emotional and acne symptoms. Each item is scored
Facial Photographs
时间窗: 2 years
The investigator or designee will take digital photographs of the participants' face using Canfield Facial Image Photography Device. Photographs will be taken under standardized conditions. Images will be captured, viewed, and uploaded using Canfield Facial Image Photography Device software which automatically checksums, encrypts, packages, and transfers the data to secure, validated and compliant web servers hosted by Canfield Clinic. Deidentified images will be used to assess the skin condition of each participant and be the input data for the AI-based tool to derive acne severity.
Application of AI-based methods for assessing acne severity from images
时间窗: 2 years
Images will be analyzed with experimental AI technologies to develop and improve acne lesion count and severity grading. Deep learning-based methods will be used to automatically detect various categories of acne lesions and assess acne severity by quantifying the number of lesions in each category. The deep learning model will be trained on the dataset with ground truth bounding box labels annotated by dermatologists, enabling it to identify lesion locations and classify each lesion type, such as inflammatory lesions (papules, pustules, nodule, and cysts), noninflammatory lesions (open comedo and closed comedo), and others (eg, scar, melasma, and nevus). Facial images for the study are captured using the Canfield Facial Image Photography Device, ensuring high-quality, standardized input for robust model performance. The trained model will output bounding boxes with lesion classifications for test images, providing a detailed and objective assessment of acne severity based on lesion c
次要结局
- Immunogenicity Assessments(2 years)
- METAGENOMIC AND METATRANSCRIPTOMIC ASSESSMENTS(2 years)
- SPATIAL AND SINGLE CELL RNA SEQUENCING(2 years)
- SKIN SURFACE MATERIAL ASSESSMENTS OR METABOLIC AND PROTEOMIC ASSESSMENTS(2 years)
- MICROBIAL ISOLATION(2 years)