CTRI/2023/10/058218已完成不适用
A clinical study to evaluate Safety, In-Use Tolerability and Efficacy of HARF-042202 in healthy adults with mild to moderate acne and acne prone skin.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Assessment of acne severity (in terms of reducing acne) using Investigator global assessment (IGA) and counting of inflammatory and non-inflammatory lesions.
研究概览
简要总结
This is anopen label, non-randomized, single-arm clinical study to evaluate safety,in-use tolerability and efficacy of test products inhealthy human subjects with acne-prone skin and with mild to moderate acne.
The potentialsubjects will be screened as per the inclusion and exclusion criteria onlyafter obtaining written informed consent from the subjects.
All eligiblesubjects will undergo clinical evaluation by a Dermatologist, instrumentevaluation and subjective evaluation. Safety will be assessed throughout the study bymonitoring adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects having good general health as determined by the Investigator on the basis of medical history.
- •Subjects with acne-prone skin and with mild to moderate acne condition as per IGA scale and acne prone skin.
- •Subjects with oily skin having Sebumeter measurement > 180 (μg/cm2).
- •Female subjects of childbearing potential must have a negative urine pregnancy test performed on screening and enrolment visit.
- •Subjects who are not under any dermatologic treatment for acne and scar/ prescribed medications.
排除标准
- •Subjects with drug induced acne as disclosed by subjects.
- •Subjects undergoing treatment for skin lightening or subjects using other marketed skin lightening products during the study period or in the past 6 weeks.
- •Subjects who are receiving topical or systemic treatments for acne or acne marks.
- •Subjects receiving medications (e.g., steroids or anti-histamines) which would compromise the study.
结局指标
主要结局
Assessment of acne severity (in terms of reducing acne) using Investigator global assessment (IGA) and counting of inflammatory and non-inflammatory lesions.
时间窗: Day 01 (before application to Day 29 (plus 2 days)
次要结局
- Assessment of acne severity (in terms of reducing acne) using Investigator global assessment (IGA) and counting of inflammatory and non-inflammatory lesions(Day 01 (before application), Day 02 (24 hr. post application), Day 03, Day 08 (plus 2 days) and Day 15 (plus 2 days))
- Assessment of Skin dryness using 5-point grading scale by Dermatologist(Day 01 (before application), Day 02 (24 hr. post application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days))
- Assessment of porphyrins using Visiopor(Day 01 (before application), Day 02, (24 hr. post application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days))
- Assessment of acne severity (in terms of preventing acne) using Investigator global assessment (IGA) and counting of inflammatory and non-inflammatory lesions(Day 01 (before application), Day 02 (24 hr. post application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) Day 29 (plus 2 days))
- Assessment of Skin redness using 5-point grading scale by Dermatologist(Day 01 (before application and 8 hours post product application), Day 02 (24 hr. post application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days))
- Assessment of Skin desquamation/flakiness using 5-point ordinal scale by Dermatologist(Day 01 (before application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days))
- Assessment of Subject Satisfaction Questionnaire after product usage(Day 01 (8 hours post product application), Day 02 (24 hr post application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days))
- Assessment of skin pigmentation using 9-point grading scale(Day 01 (before application), Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days))
- Assessment of skin barrier function by measuring Transepidermal Water Loss (TEWL) using Vapometer(Day 01 (before application), Day 02 (24 hr. post application), Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days))
- Assessment of Product Response Index (Perception about Product) after product usage(Day 29 (plus 2 days))
- Assessment of acne, erythema and acne marks/spots using 3D analysis system using Antera(Day 01 before application and 8 hours post application, Day 02 (24 hr), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days))
- Assessment of skin sebum level using Sebumeter SM 815(Day 01 (before application, 30 mins, and 8 hours post product application), Day 02 (24 hr. post application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days))
- Assessment of skin moisturization using MoistureMeterSC(Day 01 (before application, 30 mins, and 8 hours post product application), Day 02 (24 hr. post application), Day 03, Day 08 (plus 2 days), Day 15 (plus 2 days) and Day 29 (plus 2 days))
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Anti-Mesothelin CAR-T Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid TumorsNCT07010523Zhejiang University24
Unknown
1 期
UCLM802 (Anti-Mesothelin CAR-T) Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid TumorsMesothelin-positive Advanced Malignant Solid TumorsNCT05848999Zhejiang University87
尚未招募
1 期
UCLM802 (Anti-Mesothelin CAR-T) Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid TumorsSolid TumorNCT05775666Peking University87
招募中
1 期
A Clinical Study Evaluating the Safety, Tolerability, and Initial Efficacy of JWK008 in Patients With Mucopolysaccharidosis Type IMucopolysaccharidosis Type INCT06519552West China Hospital6
进行中（未招募）
1 期
A Clinical Study Evaluating the Safety, Tolerability, and Initial Efficacy of Single Intravenous Infusion of JWK007 in Patients With Duchenne Muscular Dystrophy (DMD)Duchenne Muscular DystrophyNCT06114056West China Hospital3