An open-label, single-arm, single centre, interventional, prospective, clinical safety, efficacy and in-use tolerability study of ThriveCo Scar Fader Gel and ThriveCo Bumps Eraser Kit (ThriveCo Bumps Eraser Exfoliating Scrub and ThriveCo Smoothing Body Lotion).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1)ThriveCo Scar Fader Gel
研究概览
简要总结
An open-label, single-arm, single centre, interventional, prospective, clinical safety, efficacy and in-use tolerability study of ThriveCo Scar Fader Gel and ThriveCo Bumps Eraser Kit (ThriveCo Bumps Eraser Exfoliating Scrub and ThriveCo Smoothing Body Lotion).
32 adult female subjects will be recruited/enrolled to ensure a total of 30 subjects complete the study.
Subjects will be instructed to visit the facility as per the below visits.
Visit 01 (Day 01): Screening and Enrollment
Visit 02 ( Day 21 + 2 Days): Test Treatment Usage Period, Evaluations
Visit 03 (Day 45 + 2 Days) : Evaluations, End of Study
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 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age: 18 to 60 years (both inclusive) at the time of consent.
- •Sex: Healthy non-pregnant/non-lactating females.
- •Subject are generally in good health as determined by/form recent medical history.
- •Subject must have scars (acne scar, hypertrophic scar) on their skin.
- •Subjects with keratosis pilaris/ strawberry legs/ extremely dry skin.
- •Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
- •If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence).
- •Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
- •Subjects are willing to give written informed consent and are willing to follow the study procedure.
- •Subjects who commit not to use medicated/ prescription products for scar and bumpy skin other than the test treatments for the entire duration of the study.
- •Willing to use test treatments throughout the study period.
排除标准
- •Subjects having active infection at site of scars or bumpy skin site.
- •Subject with history of dermatological condition or active dermatological condition.
- •Subject with known allergy or sensitivity to the ingredients of test treatments.
- •Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
- •Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
- •Subject is currently pregnant/breastfeeding.
- •Subject has a history of any prior scar treatment procedures (e.g., radiofrequency therapy or laser therapy).
- •Subject has a history of alcohol or drug addiction.
- •Subject having any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
- •Subject planning to become pregnant during the study period.
- •Subject with history of chronic illness which may influence the cutaneous state.
- •Subjects participating in other similar trials within the last four weeks.
结局指标
主要结局
1)ThriveCo Scar Fader Gel
时间窗: 1)ThriveCo Scar Fader Gel | From baseline before usage of test treatment on Day 01 and after usage of test treatment on Day 21(+2 Days) and Day 45(+2 Days). | 2)ThriveCo Bumps Eraser Kit | From baseline before usage of test treatment on Day 01 and after usage of test treatment at T30 mins on Day 01, Day 21(+2 Days) and Day 45(+2 Days).
1.To assess the effectiveness of the test treatment in terms of visible change in scar.
时间窗: 1)ThriveCo Scar Fader Gel | From baseline before usage of test treatment on Day 01 and after usage of test treatment on Day 21(+2 Days) and Day 45(+2 Days). | 2)ThriveCo Bumps Eraser Kit | From baseline before usage of test treatment on Day 01 and after usage of test treatment at T30 mins on Day 01, Day 21(+2 Days) and Day 45(+2 Days).
2)ThriveCo Bumps Eraser Kit
时间窗: 1)ThriveCo Scar Fader Gel | From baseline before usage of test treatment on Day 01 and after usage of test treatment on Day 21(+2 Days) and Day 45(+2 Days). | 2)ThriveCo Bumps Eraser Kit | From baseline before usage of test treatment on Day 01 and after usage of test treatment at T30 mins on Day 01, Day 21(+2 Days) and Day 45(+2 Days).
1.To assess the effectiveness of the test treatment in terms of change in skin hydration
时间窗: 1)ThriveCo Scar Fader Gel | From baseline before usage of test treatment on Day 01 and after usage of test treatment on Day 21(+2 Days) and Day 45(+2 Days). | 2)ThriveCo Bumps Eraser Kit | From baseline before usage of test treatment on Day 01 and after usage of test treatment at T30 mins on Day 01, Day 21(+2 Days) and Day 45(+2 Days).
2.To assess the effectiveness of test treatment in terms of change in in the skin redness and pigmentation.
时间窗: 1)ThriveCo Scar Fader Gel | From baseline before usage of test treatment on Day 01 and after usage of test treatment on Day 21(+2 Days) and Day 45(+2 Days). | 2)ThriveCo Bumps Eraser Kit | From baseline before usage of test treatment on Day 01 and after usage of test treatment at T30 mins on Day 01, Day 21(+2 Days) and Day 45(+2 Days).
3.To assess the effectiveness of the test treatment in terms of change in skin itchiness.
时间窗: 1)ThriveCo Scar Fader Gel | From baseline before usage of test treatment on Day 01 and after usage of test treatment on Day 21(+2 Days) and Day 45(+2 Days). | 2)ThriveCo Bumps Eraser Kit | From baseline before usage of test treatment on Day 01 and after usage of test treatment at T30 mins on Day 01, Day 21(+2 Days) and Day 45(+2 Days).
次要结局
- 1.To assess the effectiveness of the test treatment(ThriveCo Scar Fader Gel )in terms of change in skin texture.(From baseline before usage of test treatment on Day 01 and after usage of test treatment on Day 21 and Day 45.)
- 2.To assess the effectiveness of the test treatment(ThriveCo Scar Fader Gel)in terms of change in digital photographs of the scar.(From baseline before usage of the test treatment on Day 01 and after usage of test treatment on Day 21 and Day 45.)
- 3. To assess the effectiveness of the test treatment(ThriveCo Scar Fader Gel)in terms of treatment perception.(From baseline before usage of the test treatment on Day 01 and after usage of test treatment on Day 21 and Day 45.)
- 4.To assess the effectiveness of the test treatment(ThriveCo Bumps Eraser Kit) in terms of change in skin texture i.e. smoothness, roughness, scaliness.(From baseline before usage of test treatment on Day 01 and after usage of test treatment at T30 mins on Day 01, Day 21and Day 45.)
- 5.To assess the effectiveness of the test treatment(ThriveCo Bumps Eraser Kit)in terms of change in digital photographs.(From baseline before usage of the test treatment on Day 01 and after usage of test treatment at T30 mins on Day 01, Day 21 and Day 45.)
- 6.To assess the effectiveness of the test treatment(ThriveCo Bumps Eraser Kit) in terms of treatment perception after usage of the test treatment.(From baseline before usage of the test treatment on Day 01 and after usage of test treatment at T30 mins, Day 21and Day 45.)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited