A Prospective, Single Arm, Clinical Study To Evaluate TheEfficacy And Safety Of Glaze 5-In-1 Acne Control FormulaIn Patients With Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 4) From Baseline in Total Lesion Counts
研究概览
简要总结
Study Procedure:
The study who fulfilled the inclusion and exclusion criteria will be enrolled in the study . 30 Participants will be randomized in to a single group.
The application of the product will be done at site on each day of assessment throughout the study period by the subject. Subject will wash their test area with a water prior to the application. After pat dry, the test product will be applied on the acne lesions ( approximately 8-12 hours apart) twice daily throughout the study duration. After application, the subject should not wash their test site for at least 2 hours with water or any other product. Subjects will avoid unnecessary sun exposure immediately after morning product application. Take approx 1.0 gm quantity of test product on tip of index finger. Apply dot wise on whole face and then lightly spread test product using only fingers in outward direction. Ensure that you do not rub the product in to your skin. Apply the product twice daily in morning and evening on whole face for the period of 30 days
(As directed by the Dermatologist). Subject will be asked to visit Clinical Facility for their follow up at the end of 15 and 30 days and any other additional visits if needed.
Primary and secondary outcome
-
Global Acne Assessment Score (GAAS)
-
Change from baseline in Inflammatory facial Lesion counts
-
Change from Baseline in Noninflammatory Facial Lesions Counts
-
Microbiological swabs from Acne Lesion Site on baseline and Post study ( day 15 or day 30 based on healing)
-
Percentage of Patients Reporting Very Good or Excellent on Item 10 of the 5-Point Acne Symptom Impact Scale ( ASIS)
-
Overall Improvement of skin health
-
Scoring in terms of Itching
-
Instrument Analysis: Sebumetric Analysis, Corneometer Analysis
-
DLQI
-
Ease of use
-
Pre and Post study Photographic assessments
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male or female subjects in the age group of 18-45 years 2.Healthy skin in the test areas; 3.Subjects willing and capable to follow the study rules and a fixed schedule; 4.Ability of giving consent for participation in the study; 5.Subjects with good health in general and good mental condition; 6.Subjects who present at least 10 inflammatory lesions; 7.Oily skin on the face.
排除标准
- •1.Pregnancy or breastfeeding; 2.Subjects who present severe acne; 3.Subjects who present more than two nodular lesions; 4.Subjects who changed their oral contraception method up to three months before the study beginning; 5.Subjects who did acne hormonal treatment less than 6 months before the study; 6.Subjects who did oral isotretinoïne treatment less than 1 month before the study; 7.Subjects who did topical acne treatment less than 90 months before the study; 8.Subjects who did aesthetic treatment less than 6 months before the study (like laser and peeling); 9.Subjects who did treatment with antibiotics within the last 4 months; 10.Simultaneous participation in different studies from external research institutes on the same test sites 11.Hypersensitivity to any of the ingredients of the test product.
- •12.Pregnant or lactating women 13.Patients on steroid therapy or any other immunomodulatory agents.
结局指标
主要结局
4) From Baseline in Total Lesion Counts
时间窗: Day 0, 15 and 30
5)Microbiological Swab from the Acne lesion site will be taken
时间窗: Day 0, 15 and 30
6)Instrumental Assessment:
时间窗: Day 0, 15 and 30
1) Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5- point Global Acne Assessment Score (GAAS)
时间窗: Day 0, 15 and 30
-Sebumetric analysis (Baseline, 1Hr, 2Hr, 6Hr, 12Hr and 24Hrs post application) and also post study at day 30.
时间窗: Day 0, 15 and 30
- Corneometer analysis for skin Moisturization (Baseline, 1Hr, 2Hr, 6Hr, 12Hr and 24Hrs post application)
时间窗: Day 0, 15 and 30
7) Dermatology Life Quality Index (DLQI) questionnaire
时间窗: Day 0, 15 and 30
2)Change From Baseline in Inflammatory Facial Lesion Counts
时间窗: Day 0, 15 and 30
3)Change From Baseline in Noninflammatory Facial Lesion Counts
时间窗: Day 0, 15 and 30
次要结局
- Patient and Investigator Feedbacks will be obtained(Adverse event monitoring)