Investigation of the effectiveness, tolerability and safety of ilon® Salbe classicin the treatment of acute inflammation of the hair follicle (folliculitis) Prospective, open, evaluator-blinded, randomized, placebo-controlled multicenter trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 101
研究概览
简要总结
The primary efficacy endpoint was the change in total follicle lesion counts from Visit 1 (Day 1) to the day of study completion (Final Visit). A reduction in follicle lesion counts was observed in both treatment groups, but the difference did not reach statistical significance in the ITT or Per-Protocol population. With regards to the secondary endpoints, i.e., reduction by at least one lesion count from Day 1 to the day of study completion, total follicle lesion counts weighted by observer assessment from Day 1 to the day of study completion, and general assessment by the physician, no statistically significant superiority of the active treatment (ISC) – compared to placebo was seen. According to investigators, the mean intensity of folliculitis assessed on a 11-point visual analogue scale was reduced from 5.8 (ISC) and 5.4 (placebo) at Day 1 to 2.3 (ISC) and 2.5 (placebo) at the day of study completion (Day 14). Accordingly, a larger improvement was seen in the ISC group compared to the placebo group, but the difference was not statistically significant. According to the patient’s subjective assessment, ISC was significantly better than placebo (p = 0.005). ISC was generally well tolerated. The number of adverse events was low with no relevant differences to placebo treatment. In summary, the main phase of the study failed to demonstrate superiority in efficacy for ISC vs. placebo in the primary endpoint. There are, however, some caveats to the interpretation of this outcome, limiting the reliability of the results and thus of the conclusions that can be drawn from this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •A) Caucasian
- •B) Age 18 – 80 years
- •C) Gender: female or male
- •D) Acute folliculitis with 2 to 12 hair folliculitis lesions in a defined area of 5x5 cm
- •E) Actively cooperating to participate in the trial, to follow the instructions of the Investigator and to attend the agreed visits.
- •F) Patient has signed the consent form after the nature of the trial was fully explained by the Investigator and understood by the patient.
- •G) At least one evaluable photograph of the skin area to be treated has been taken at visit 1
排除标准
- •A) Presence of acne or skin lesions, e.g. open wounds or ulcers in the respective skin area
- •B) Presence of potential fungal or viral caused skin infections
- •C) Presence of skin diseases other than acute folliculitis and interfering with study treatment
- •D) Treatment with epidermal growth factor receptor (EGFR) inhibitors
- •E) Topical use of any dermatological product (e.g. medications, medicinal products, cosmetic products) on the trial areas during the trial.
- •F) Any systemic or topical immunosuppressive therapy (e.g. corticosteroids) within 3 weeks prior to randomization.
- •G) Congenital or acquired immunodeficiency
- •H) Participation in any other trial within 30 days prior to randomization or during the trial.
- •I) Contraindications to any component of the study medication.
- •J) Known allergy or intolerance to any component of the study medication
- •K) History of drug, alcohol or chemical abuse
- •L) Other(s), considered as important by the Investigator (e.g. multiple naevi in trial area, important hair growth in trial area, pigmented skin impairing visual assessment etc.).
- •M) Pregnant or lactating females