Clinical Insights Into Dextrose Phonophoresis on Mild to Moderate Acne Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Acne Global Severity Scale (AGSS):
研究概览
简要总结
Acne vulgaris is a common cutaneous inflammatory disorder of the pilosebaceous unit, which runs a chronic course. The condition commonly manifests with papules, pustules, or nodules primarily on the face, although it can also affect the upper arms, trunk, and back. The pathogenesis of acne vulgaris involves the interaction of multiple factors that ultimately lead to the formation of its primary lesion, which is known as "comedo" (see Image. Acne Vulgaris). Although acne vulgaris is commonly observed among adolescents, it is not restricted to this age group and can affect individuals of various ages. The severity of this condition can vary, ranging from a mild presentation with only a few comedones to more severe forms characterized by disfiguring inflammatory manifestations, which can lead to hyperpigmentation, scarring, and adverse psychological effects.
详细描述
Dextrose phonophoresis emerges as a novel therapeutic modality in the management of mild to moderate acne vulgaris, an inflammatory skin condition that affects a significant portion of the adolescent and adult population. The rationale for employing dextrose phonophoresis lies in its dual mechanism of enhancing drug delivery and providing anti-inflammatory effects. Phonophoresis, which involves the use of ultrasound waves to enhance the transdermal delivery of topically applied medications, can potentiate the penetration of dextrose into the skin. Dextrose, a simple sugar, is hypothesized to modulate local inflammation and promote healing. This method leverages the mechanical effects of ultrasound to increase the permeability of the stratum corneum, thereby facilitating deeper penetration of dextrose into the dermal layers where it can exert its therapeutic effects.
The anti-inflammatory properties of dextrose are pivotal in its role in treating acne vulgaris. Acne is characterized by the inflammation of pilosebaceous units, and dextrose is believed to mitigate this inflammation through osmotic and possibly metabolic pathways. By reducing the inflammatory response, dextrose phonophoresis may decrease the erythema and lesion count associated with acne vulgaris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
double blinded
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18 to 30 years.
- •Clinically diagnosed with mild to moderate acne vulgaris.
- •Willingness to comply with the study protocol and attend all treatment sessions.
- •Medical Clearance: Participants must have medical clearance to participate in this study.
排除标准
- •Individuals with severe acne vulgaris or other dermatological conditions affecting the face.
- •Current use of systemic acne medications or topical treatments other than the study intervention.
- •Known allergy to magnesium or ultrasound gel.
- •Pregnant or breastfeeding individuals.
- •Severe Comorbidities: Individuals with severe cardiovascular, pulmonary, metabolic, or vascular diseases
- •Medication Interference: Individuals using medications known to affect presence of acne.
- •Acute Psychological Conditions: Participants with acute psychological conditions that may interfere with participation or assessments.
- •Obese patient whose BMI ≥ 30.
结局指标
主要结局
Acne Global Severity Scale (AGSS):
时间窗: at baseline and at 4 weeks
The Acne Global Severity Scale is a qualitative tool used to evaluate the overall severity of a patient's acne.Based on the examination, acne severity is classified into a standardized scale:((0: Clear skin with no inflammatory or non-inflammatory lesions,1: Almost clear with rare non-inflammatory lesions and no more than one small inflammatory lesion,2: Mild presence of non-inflammatory lesions with few inflammatory lesions,3: Moderate presence of numerous non-inflammatory lesions and several inflammatory lesions,4: Severe presence of many non-inflammatory and inflammatory lesions, including nodules).0-1: Represents mild or no acne; often considered within normal limits.2-4: Indicates increasing severity needing clinical intervention.
Acne Severity Index (ASI):
时间窗: at baseline and at 4 weeks
The Acne Severity Index is a quantitative measure that combines lesion counts and types to produce a single score.Score Calculation: Use the following formula to calculate the ASI :(( ASI = (Number of Comedones) + (2 × Number of Papules) + (3 × Number of Pustules) + (4 × Number of Nodules)).Scores can vary significantly; typically, lower scores (\<10) indicate mild acne, while higher scores (20+) suggest moderate to severe acne.
Total Lesion Count (TLC)
时间窗: at baseline and at 4 weeks
Total Lesion Count is a straightforward quantitative assessment: Counting: Count all types of acne lesions (comedones, papules, pustules, nodules) on the face, chest, and back.(0-10 lesions: Considered mild,11-25 lesions: Moderate severity,26+ lesions: Severe acne requiring intervention).
Acne Global Severity Scale (AGSS):
时间窗: at baseline and at 4 weeks
The Acne Global Severity Scale is a qualitative tool used to evaluate the overall severity of a patient's acne.Based on the examination, acne severity is classified into a standardized scale:((0: Clear skin with no inflammatory or non-inflammatory lesions,1: Almost clear with rare non-inflammatory lesions and no more than one small inflammatory lesion,2: Mild presence of non-inflammatory lesions with few inflammatory lesions,3: Moderate presence of numerous non-inflammatory lesions and several inflammatory lesions,4: Severe presence of many non-inflammatory and inflammatory lesions, including nodules).0-1: Represents mild or no acne; often considered within normal limits.2-4: Indicates increasing severity needing clinical intervention.
Acne Severity Index (ASI):
时间窗: at baseline and at 4 weeks
The Acne Severity Index is a quantitative measure that combines lesion counts and types to produce a single score.Score Calculation: Use the following formula to calculate the ASI :(( ASI = (Number of Comedones) + (2 × Number of Papules) + (3 × Number of Pustules) + (4 × Number of Nodules)).Scores can vary significantly; typically, lower scores (\<10) indicate mild acne, while higher scores (20+) suggest moderate to severe acne.
Total Lesion Count (TLC)
时间窗: at baseline and at 4 weeks
Total Lesion Count is a straightforward quantitative assessment: Counting: Count all types of acne lesions (comedones, papules, pustules, nodules) on the face, chest, and back.(0-10 lesions: Considered mild,11-25 lesions: Moderate severity,26+ lesions: Severe acne requiring intervention).
次要结局
未报告次要终点
研究者
Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d
Assisstant professor
MTI University