A Prospective, Single Arm, Clinical Study to Evaluate the Efficacy and Safety of Acne Moisturizer 6 in 1 Acne Control Cream Formula in Patients with Acne Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.Percentage of Patients with a Score of 0 or 1 on GAAS Percentage of patients with minimal or no acne on the GAAS scale.
研究概览
简要总结
Study Summary
Objectives:
- To evaluate the efficacy of ACNE MOISTURIZER 6 IN 1 ACNE CONTROL CREAM FORMULA in reducing acne.
- To assess the safety of ACNE MOISTURIZER 6 IN 1 ACNE CONTROL CREAM FORMULA.
Eligibility Criteria:
- Inclusion Criteria:
- Healthy male or female subjects aged 18-45 years.
- Healthy skin in the test areas. Participants will apply 1.0 gm of the test product twice daily for 30 days, using only fingers to spread the product in an outward direction without rubbing it into the skin.
- Subjects willing and able to follow the study guidelines and a fixed schedule.
- Ability to give informed consent for participation.
- Subjects with good general health and mental condition.
- At least 10 inflammatory lesions present.
- Oily skin on the face.
- Subjects must visit the clinical facility for follow-ups at day 15 and day 30, with additional visits as needed.
- Exclusion Criteria:
- Pregnancy or breastfeeding.
- Severe acne or more than two nodular lesions.
- Changes in oral contraception method within 3 months prior to the study.
- Acne hormonal treatment less than 6 months prior to the study.
- Oral isotretinoin treatment within 1 month of the study.
- Topical acne treatment within 90 days before the study.
- Aesthetic treatments (e.g., laser, peeling) within 6 months prior to the study.
- Antibiotic treatment within the last 4 months.
- Simultaneous participation in other clinical studies involving the same test sites.
- Hypersensitivity to any ingredient of the test product.
- Patients on steroid or other immunomodulatory therapy.
Participants will apply the test product twice daily and visit the clinical facility for follow-up evaluations to assess acne reduction and skin safety.
- Percentage of Patients with a Score of 0 or 1 on GAAS: Percentage of patients with minimal or no acne on the GAAS scale.
- Change in Inflammatory Lesions: Change in the number of inflammatory lesions from baseline.
- Change in Noninflammatory Lesions: Change in the number of noninflammatory lesions from baseline.
- Change in Total Lesion Counts: Overall change in facial lesion count from baseline.
- Microbiological Swab: Swab taken from acne lesion site at baseline and post-study (day 15 or 30).
- Percentage Reporting "Very Good" or "Excellent" on ASIS Item 10: Percentage of patients rating acne symptom impact as "Very Good" or "Excellent."
- Overall Improvement in Skin Health: Skin health improvement measured on a 5-point scale.
- Burning, Itching, Tingling, Stinging Scores: Scores for any skin reactions (0-3 scale).
- Sebumetric Analysis: Sebum level measurements at various time points.
- Corneometer Analysis for Moisturization: Moisturization levels assessed at multiple times.
- Dermatology Life Quality Index (DLQI): Quality of life impact assessed using the DLQI questionnaire.
- Ease of Use: Patient feedback on product texture and fragrance (1-4 scale).
Pre and Post Study Photographic Assessments: Photos taken before and after the study to assess skin condition
· Patient and Investigator Feedbacks will be obtained, Adverse event monitoring
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 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male or female subjects in the age group of 18-45 years
- •Healthy skin in the test areas
- •Subjects willing and capable to follow the study rules and a fixed schedule
- •Ability of giving consent for participation in the study
- •Subjects who present at least 10 inflammatory lesions
- •Oily skin on the face.
排除标准
- •Pregnancy or breastfeeding
- •Subjects who present severe acne
- •Subjects who present more than two nodular lesions
- •Subjects who changed their oral contraception method up to three months before the study beginning
- •Subjects who did acne hormonal treatment less than 6 months before the study
- •Subjects who did oral isotretinoine treatment less than 1 month before the study
- •Subjects who did aesthetic treatment less than 6 months before the study (like laser and peeling)
- •Subjects who did treatment with antibiotics within the last 4 months
- •Simultaneous participation in different studies from external research institutes on the same test sites
- •Hypersensitivity to any of the ingredients of the test product.
- •Pregnant or lactating women
- •Patients on steroid therapy or any other immunomodulatory agents.
结局指标
主要结局
1.Percentage of Patients with a Score of 0 or 1 on GAAS Percentage of patients with minimal or no acne on the GAAS scale.
时间窗: DAy 0, day 15 and day 30
2.Change in Inflammatory Lesions
时间窗: DAy 0, day 15 and day 30
3.Change in Noninflammatory Lesions Change in the number of noninflammatory lesions from baseline.
时间窗: DAy 0, day 15 and day 30
4.Change in Total Lesion Counts Overall change in facial lesion count from baseline.
时间窗: DAy 0, day 15 and day 30
5.Microbiological Swab Swab taken from acne lesion site at baseline and post-study (day 15 or 30).
时间窗: DAy 0, day 15 and day 30
7.Overall Improvement in Skin Health.
时间窗: DAy 0, day 15 and day 30
6.Percentage Reporting "Very Good" or "Excellent" on ASIS Item 10: Percentage of patients rating acne symptom impact as "Very Good" or "Excellent.
时间窗: DAy 0, day 15 and day 30
8. Burning, Itching, Tingling, Stinging Scores.
时间窗: DAy 0, day 15 and day 30
9.Sebumetric Analysis.
时间窗: DAy 0, day 15 and day 30
10.Corneometer Analysis
时间窗: DAy 0, day 15 and day 30
11.Dermatology Life Quality Index
时间窗: DAy 0, day 15 and day 30
12.Ease of Use.
时间窗: DAy 0, day 15 and day 30
13.Pre and Post Study Photographic Assessments
时间窗: DAy 0, day 15 and day 30
次要结局
- •Patient and Investigator Feedbacks will be obtained(•Adverse event monitoring)
研究者
Dr Roshany
DK Elite Health Care Centre