CTRI/2022/09/045342招募中4 期
Prospective, randomized, comparative study of topical Minocycline gel 4% vs topical clindAmycin phosphate gel 1% in Indian patients with acNe vulgaris.
Dr Deval Mistry0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients eligible for enrolment in the study must meet all of the following criteria:
- •1) Patients aged 9 years or more, of either gender diagnosed with acne vulgaris defined by:
- •a) Grade 1-4 of acne
- •Grade 1: Comedones, occasional papules.
- •Grade 2: Papules, comedones, few pustules.
- •Grade 3: Predominant pustules, nodules, abscesses. Grade 4: Mainly cysts, abscesses, widespread scarring.
- •b) IGA score of 0-5
- •1: Almost Clear
- •3: Moderate
- •5: Very Severe
- •2) Patients who will refrain from use of any other acne medication, medicated cleanser, excessive sun exposure for the duration of the study.
- •3) Patients who are willing to use effective contraceptive method for the duration of the study.
- •4) Patients/their parents/legal guardians/representatives willing to give consent/assent to participate in the study.
排除标准
- •Patients meeting any of the following criteria must not be enrolled in the study:
- •1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.
- •2. Severe systemic disease as assessed by the Investigator that might interfere with the conduct of the study or the interpretation of the results.
- •3. Sunburn on the face.
- •4. Female patients who are pregnant, lactating, or planning a pregnancy.
- •5. Patients who have a documented history or known case of any of the following:
- •a. Allergy to tetracycline-class antibiotics or to any ingredient in the study drug.
- •b. Pseudomembranous colitis or antibiotic-associated colitis.
- •c. Known or suspected premalignant or malignant disease (excluding successfully treated skin cancers).
- •6. Clinically significant hepatic impairment (ALT & AST values >3 times upper limit)/renal impairment (eGFR ( <90 mL/min).
- •7. Patients who have used the following medications:
- •Within 1 week prior to screening:
- •a) Medicated facial cleansers on the face.
- •b) Topical acne treatments on the face (other than those listed below).
- •Within 4 weeks prior to screening:
- •a) Topical retinoid (e.g. tretinoin, tazarotene, adapalene) on the face.
- •b) Topical antimicrobials (e.g. clindamycin, erythromycin)
- •c) Topical anti-inflammatories and/or corticosteroids on the face, benzoyl peroxide, salicylic acid, Ã?±-hydroxy/glycolic acid
- •d) Systemic antibiotics (Minocycline, doxycycline).
- •e) Systemic acne treatments.
- •Within 12 weeks prior to screening:
- •a) Systemic retinoid.
- •b) Systemic corticosteroids
- •c) Estrogens or change in oral contraceptives therapy
- •8. Have received an investigational therapy (including investigational drug or procedure) and vaccines including COVID-19 vaccine within 28 days of screening or plan to use one during the study.
- •9. Refusal to participation expressed by patient or legal guardian/representative.
研究者
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