CTRI/2023/04/051390已完成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
- 已完成
- 入组人数
- 256
- 试验地点
- 8
- 主要终点
- To evaluate the local skin tolerability (erythema, dryness, hyperpigmentation, skin peeling, pruritus) of minocycline hydrochloride topical gel 4% in Indian patients with moderate to severe acne vulgaris
研究概览
简要总结
Thisprospective, open label, multicentre, single arm, Phase IV study is toinvestigate the safety, tolerability and efficacy of minocycline hydrochloridetopical gel 4% in Indian patients with moderate to severe acne vulgaris. 256 patients will be enrolled in study across India and followed up for 12 Weeks. Safetywill be assessed for local skin tolerability on 4 point scale (0=none;3=severe). Efficacyevaluations (acne lesion count, investigator’s global assessment) will beperformed at baseline, week 3, 6, 9 and 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 9.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Each patient must meet all of the following criteria to be enrolled in the study:
- •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)
- •Patients who will refrain from use of any other acne medication, medicated cleanser, excessive sun exposure for the duration of the study.
- •Patients who are willing to use effective contraceptive method for the duration of the study.
- •Patients/their parents/legal guardians/representatives willing to give consent/assent to participate in the study.
排除标准
- •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.
- •Severe systemic disease as assessed by the Investigator that might interfere with the conduct of the study or the interpretation of the results.
- •Sunburn on the face.
- •Female patients who are pregnant, lactating, or planning a pregnancy.
- •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.
- •Pseudomembranous colitis or antibiotic-associated colitis.
- •Known or suspected premalignant or malignant disease (excluding successfully treated skin cancers).
- •Clinically significant hepatic impairment (ALT & AST values >3 times upper limit)/renal impairment (eGFR (<90 mL/min) and positive ANA titer.
- •Patients who have used the following medications: Within 1 week prior to screening: • Medicated facial cleansers on the face.
- •â€¢ 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.
- •â€¢ Topical antimicrobials (e.g. clindamycin, erythromycin) • Topical anti-inflammatories and/or corticosteroids on the face, benzoyl peroxide, salicylic acid, α-hydroxy/glycolic acid • Systemic antibiotics (Minocycline, doxycycline).
- •â€¢ Systemic acne treatments.
- •Within 12 weeks prior to screening: • Systemic retinoid.
- •â€¢ Systemic corticosteroids • Estrogens or change in oral contraceptives therapy
- •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
- •Refusal to participation expressed by patient or legal guardian/representative.
结局指标
主要结局
To evaluate the local skin tolerability (erythema, dryness, hyperpigmentation, skin peeling, pruritus) of minocycline hydrochloride topical gel 4% in Indian patients with moderate to severe acne vulgaris
时间窗: up to 84 days
次要结局
- 1) Number of adverse events (AEs), serious adverse events (SAEs), treatment related AEs and SAEs and AEs leading to dose modification/discontinuation of treatment(2) Change from baseline in the inflammatory and non-inflammatory lesion count at week 3, 6, 9 and 12)
研究者
研究点 (8)
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