An Open-Label, Single-Arm, Single-Center, Phase III Clinical Study to Evaluate the Safety and Efficacy of RSO Plus oil in Subjects with Cellulitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
Brief SummaryCellulitis is a common bacterial infection of the skin and subcutaneous tissue, characterized by redness, swelling, warmth, and tenderness. Despite standard antibiotic therapy, recurrence and incomplete resolution of local symptoms remain frequent due to persistent inflammation and impaired skin barrier recovery.
RSO Plus Oil is a proprietary Ayurvedic formulation containing herbal oils with anti-inflammatory, antimicrobial, antioxidant, and wound-healing properties. The formulation is intended for topical use to alleviate local symptoms, promote healing, and enhance quality of life in patients with cellulitis.
This open-label, single-arm, single-center clinical study aims to evaluate the efficacy, safety, and tolerability of RSO Plus Oil applied topically once daily for 40 days in adult female subjects with mild-to-moderate cellulitis. The primary endpoint is the reduction in erythema, swelling, burning sensation, and hypersensitivity from baseline to end of treatment. Secondary objectives include improvement in skin texture and firmness, quality of life, and subject satisfaction.
Results:
This Phase III, open-label, single-arm clinical study demonstrated that topical application of RSO Plus Oil resulted in clinically meaningful improvement in adult female subjects with mild-tomoderate cellulitis over a 40-day treatment period. Statistically and clinically relevant reductions were observed in both physician-assessed and patient-reported local symptoms of cellulitis, including erythema, skin irritation, burning sensation, and hypersensitivity, indicating effective local symptom control. The study also shows effect of RSO Plus Oil on subcutaneous fat deposits. Progressive reductions in extra fat deposited under the skin were observed across multiple body regions, including the abdomen, thighs, hips, arms, and neck, along with visible improvements in skin appearance.
Consistent improvements were noted across secondary efficacy endpoints. Cellulite severity and skin texture/firmness demonstrated progressive improvement as assessed by the Cellulite Severity Scale (CSS). Quality of life, measured using the Dermatology Life Quality Index (DLQI), showed improvement across all domains, reflecting reductions in physical discomfort, emotional distress, and interference with daily activities and social functioning. Subject satisfaction and cosmetic acceptability assessments further supported favourable user experience and perceived therapeutic benefit. RSO Plus Oil was well tolerated throughout the study. No serious adverse events were reported. All adverse events were mild, transient, resolved without medical intervention, and were assessed as unrelated to the investigational product. High treatment compliance further supported the feasibility and acceptability of daily topical application.
In conclusion, RSO Plus Oil demonstrated a favourable safety profile and clinically meaningful efficacy in reducing local cellulitis symptoms, improving cellulite severity and skin quality, and reducing subcutaneous fat deposits across multiple body areas. These findings support its potential role as a safe and effective adjunctive topical therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female participants aged 18–50 years.
- •Clinically diagnosed cellulitis of mild-to-moderate severity (as per investigator’s judgment).
- •No active dermatologic conditions or recent skin infections in the treatment area that could interfere with topical application.
- •Stable general health without chronic medical conditions requiring systemic therapy during the study period.
- •Willing and able to provide written informed consent prior to any study-related procedures.
- •Willing to comply with study requirements, including scheduled visits, questionnaires, and use of the investigational product as instructed.
排除标准
- •History of skin allergy, eczema, or hypersensitivity in the treatment area.
- •Pregnant or breastfeeding women, or those planning pregnancy during the study period.
- •Known allergy or intolerance to any component of RSO Plus Oil.
- •Presence of severe cellulitis requiring immediate systemic antibiotic therapy or hospitalization.
- •Participation in another clinical study or use of investigational drugs within the last 30 days prior to screening.
- •Current use of other topical medicated/herbal treatments on the affected area.
- •Any condition that, in the opinion of the investigator, may compromise subject safety, compliance, or study integrity.
研究者
Dr Jamuna B A
RVS Ayurvedic Medical College Hospital and Research Centre