CTRI/2023/04/051390进行中（未招募）4 期
Prospective, open label, multicentre, single arm, Phase IV study for evaluation of safety, tolerability and efficacy of minocycline hydrochloride topical gel 4% in Indian patients with moderate to severe acne vulgaris.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
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
- •Each patient must meet all of the following criteria to be enrolled in the study:
- •1. Patients aged 9 years or more, of either gender diagnosed with moderate to severe acne vulgaris defined by:
- •a. 20 to 50 inflammatory lesions (papules, pustules, and nodules)
- •b. 25 to 100 non-inflammatory lesions (open and closed comedones)
- •c. No more than 2 nodules on the face
- •d. IGA score of moderate (3) to severe (4)
- •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
- •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) and positive ANA titer.
- •7. Patients who have used the following medications:
- •Within 1 week prior to screening:
- •Medicated facial cleansers on the face.
- •Topical acne treatments on the face (other than those listed below).
- •Within 4 weeks prior to screening:
- •Topical retinoid (e.g. tretinoin, tazarotene, adapalene) on the face.
- •Topical antimicrobials (e.g. clindamycin, erythromycin)
- •Topical anti-inflammatories and/or corticosteroids on the face, benzoyl peroxide, salicylic acid, a-hydroxy/glycolic acid
- •Systemic antibiotics (Minocycline, doxycycline).
- •Systemic acne treatments.
- •Within 12 weeks prior to screening:
- •Systemic retinoid.
- •Systemic corticosteroids
- •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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