Efficacy of Manuka Honey Nano-Formulatin on the Clinical Improvement and Inflammatory Markers Reduction in Patients With Acne Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 102
- 主要终点
- Acne severity evaluation
研究概览
简要总结
The present study aims to manufacture manuka honey-loaded nano-formulation using natural materials as a potent tissue-healing remedy and compare it to commercially available antimicrobial therapy in order to reduce the severity and recurrences of skin lesions.
详细描述
It was found that patients with acne suffer from lower self-esteem, depression, anxiety, and social isolation as a result of papules, pustules, nodules, cysts, and scarring. Moreover, a common complication of acne is residual post-inflammatory hyperpigmentation and acne scaring which cause further psychological and social distress. Collectively, these factors explain the reduction of quality of life .
The intervention for AV treatment has been unaltered throughout last years. There is a global shift from antibiotics concerning limiting their use due to increasing antibiotic resistance. Hence, it is imperative to provide natural products as another modality of treatment.
Manuka honey (MH) is a mono-floral honey harvested by honeybees (Apis mellifera) after pollinating and collecting nectar primarily from the Manuka tree. MH's anti-inflammatory and broad-spectrum antibacterial activity is due to its major ingredients, hydrogen peroxide H2O2 produced enzymatically, non-peroxidase methylglyoxal (MGO), and the peptide bee defensin-1 which has antimicrobial action. Furthermore, MH inhibits bacterial growth by high osmolality and low pH. A high MGO content MH nano-formulation will be fabricated to serve as a vehicle for its topical delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
The intervention of each group
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate acne vulgaris patients.Patients will be assessed for severity of acne by Global acne grading system (GAGS).
- •Age of patients: 18-40 years.
- •Sex: both sexes.
排除标准
- •Pregnancy and lactation.
- •severe acne vulgaris.
- •exogenous acne as industrial or cosmetic causes.
- •Patients with photodermatitis or allergic dermatitis.
- •serious or systemic illnesses such as liver and renal dysfunction.
- •Patients with radiotherapy, cryotherapy, cutaneous malignant tumors, and patients suffer from mental illnesses.
结局指标
主要结局
Acne severity evaluation
时间窗: 4 weeks
Acne severity evaluation : The skin lesion scores were calculated before treatment and 4 weeks after treatment according to Global acne grading system (GAGS). (Yun Chen MM et al.,2023).
Clinical evaluation
时间窗: 4 weeks
Clinical evaluation: (Yun Chen MM et al.,2023) * cure :Reduction of lesion area ≥90% * Significant effect: The lesion area was reduced by 60%-89% * Effective: Skin lesion area reduced by 30%-59% * Invalid: Reduction of lesion area ≤29% * cure :Reduction of lesion area ≥90% * Significant effect: The lesion area was reduced by 60%-89% * Effective: Skin lesion area reduced by 30%-59% * Invalid: Reduction of lesion area ≤29%
次要结局
- Specific parameter interleukin-17 (IL-17) measurement(4 weeks)
- Specific parameters (interleukin-1 beta ) (IL-1β)measurement(4 weeks)
- Specific parameter C-reactive protein (CRP) measurement(4 weeks)
研究者
Maha khalifa
Associate Professor, Pharmaceutics Department, Al-Azhar University
Al-Azhar University