Efficacy and Tolerability of Rehmannia Glutinosa Leaf Extract in the Treatment of Acne Vulgaris: a Double Blinded, Randomized, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Acne severity: The global acne grading system
研究概览
简要总结
In this study, The Investigator will be assessing the efficacy and tolerability of Rehmannia glutinosa Libosch leaf-based extract formulation consumption on the treatment of Acne Vulgaris in a randomized, double-blind, placebo-controlled study for the duration of 56 days.
详细描述
In this study, The Investigator will be assessing the efficacy and tolerability of Rehmannia glutinosa Libosch leaf-based extract formulation consumption on the treatment of Acne Vulgaris in a randomized, double-blind, placebo-controlled study. The participants will consume one capsule per day containing active ingredient for the duration of 56 days. Throughout the duration of the clinical trial, The Investigator will be studying the formulation's effects on the change in the Global Acne Grading System (GAGS) score, facial sebum secretion, the number and irritability of inflammatory lesions, quality of life via the Acne-QoL questionnaire, skin wrinkle severity through the Modified Fitzpatrick Wrinkle Severity Scale (MFWS) and the percentage population of responders at the end of the study. The Investigator will also assess the change in skin radiance, luminosity, smoothness, texture, firmness, and skin hydration through a participant based self-assessment questionnaire as well as the safety and tolerability of the formulation through a global evaluation by the participants and the investigators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 18 to 35 years
- •Body Mass Index (BMI) in the range of ≥ 18.5 to ≤ 29.9 kg/m
- •Moderate to severe acne as per GAGS (defined with a score of 19 to 38)
- •Participants ready to continue usual skin care regime till the entirety of study duration.
- •Participant willing to abstain Anti-acne preparations (creams, face wash, home remedies, etc) throughout the study.
- •Participants must be ready to abstain from any food supplements or medications and other related products apart from the ones allowed during the study period.
- •Participants must be willing to complete all study designated questionnaires and diaries or any other related procedures or requirements.
- •Participants having the ability to understand and sign a written informed consent form.
排除标准
- •Unwilling to forgo any aesthetic or dermatological treatments or procedures during the study period.
- •Consumption of any over-the-counter or prescribed oral anti-acne medications during the last 3 months prior to screening
- •Currently applying any over-the-counter or prescribed anti-acne medication including, but not limited to, retinoic acid or benzoyl peroxide over the past 3 months prior to screening.
- •Participants who have used facial, topical or injectable steroids 6 weeks prior to screening and during the study.
- •Females suffering from Polycystic Ovary Syndrome (PCOS).
- •Participant using oil and oil-based preparations for skin.
- •Consumptions of any herbal preparation, supplements, nutritional therapy or any other medications that is expected to improve acne over the past two weeks from randomization.
- •History of Hormonal imbalance
- •Abnormal Thyroid Stimulating Hormone (TSH) value which is < 0.35 or > 4.94 µIU/mL.
- •Participant with high caffeine consumption, (defined as >3 cups of coffee consumption in a day).
- •Topical or systemic use of antifungals and antibiotics in the previous 2 weeks prior to screening.
- •Participant having extremely oily food habits.
- •Participants taking drugs known to be photosensitizers including, but not limited to, phenothiazines, amiodarone, quinine, thiazides, tetracyclines, sulphonamides, quinolones
- •Known sensitivity to the investigational product or any excipients of the drug product.
- •Smoking or using any tobacco products.
- •Having a history of chronic skin allergies.
- •History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
- •Participation in other clinical trials in last 30 days prior to screening
- •Participants with substance abuse problems (within 2 years) defined as:
- •Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
- •High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week for women.
- •Patients who have clinically significant following severe illness (i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.)
- •Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
- •Any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.
结局指标
主要结局
Acne severity: The global acne grading system
时间窗: Day 0 Day 28 and Day 56
Acne lesions will be counted separately for all the six locations. Then the acne score (S) will be multiplied with the area factor (F) to get local score of that particular area. All six local scores will be summed to get the total scores. The total acne severity scores will be obtained on day 0, day 28, and day 56. The change in acne severity of all the enrolled participants will be assessed after 28 and 56 days of supplementation from baseline (Day 0) and in comparison to placebo.
次要结局
- Count of inflammatory acne lesions(Day 0 Day 28 and Day 56)
- Acne Quality of life questionnaire(Day 0 Day 28 and Day 56)
- Percentage responders(Day 0 Day 28 and Day 56)
- Pain VAS(Day 0 Day 28 and Day 56)
- Global evaluation of the efficacy by investigator(Day 56)
- Sebum secretion(Day 0 Day 28 and Day 56)
- Modified Fitzpatrick Wrinkle Severity Scale(Day 0 Day 28 and Day 56)
- Skin parameters using a participant based self-assessment questionnaire(Day 0 Day 28 and Day 56)
- Itch VAS(Day 0 Day 28 and Day 56)
- Global evaluation of the tolerability by Participant(Day 56)