A Randomized, Double-Blind, Three-Arm, Prospective, Single-Center Clinical Study to Evaluate the Safety, Efficacy, and Tolerability of Pinorox® in Subjects with Facial Signs of Aging
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of the test treatment(s) by assessing change in
研究概览
简要总结
This is a randomized, double-Blind, three-arm, prospective, single-centre clinical study to evaluate the safety, efficacy, and tolerability of pinorox® in subjects with facial signs of aging. A total of 81 subjects (27 subjects/treatment) will be enrolled in the study, comprising male and non-pregnant, non-lactating female participants aged 35 to 55 years (inclusive). Subjects must present with visible Crow’s feet wrinkles, fine lines, and facial dark spots at baseline. Participants will be equally distributed across three treatment groups with 27 subjects per group.
There will be total of 3 visits during the study. The duration of the study will be 60 Days (8 weeks) from the enrolment. Subjects will be instructed to visit the facility as per below visits.
ü Visit: 01 (Day 01, Week 00): Screening, ICD obtained, Enrolment, Baseline readings and post product usage readings.
ü Visit 02 (Day 30, Week 04): Treatment Phase, Evaluations
ü Visit 03 (Day 60, Week 08): Evaluations andTreatment Phase end | End of Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 35 to 55 years (both inclusive) at the time of consent.
- •Sex: Adult male and female having Crow’s feet area wrinkles, fine lines, facial dark spots.
- •Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit.
- •Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin ageing in last 3 months.
- •Subjects are not allowed to participate in any other study until this study is complete.
- •Subjects must be willing and able to follow the study directions and to return for all specified visits with the product.
- •Subjects must agree to record each use of the test products in the subject’s diary card on daily basis.
- •Subjects must agree to record medication use during the study.
排除标准
- •Subjects who are on steroids for last six months.
- •Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last three months.
- •Subjects who are on product which contains kojic acid, glycolic acid, niacinamide, alpha arbutin, Vitamin C and other skin ageing product.
- •Subjects with other dermatologic diseases whose presence or treatments could interfere with the assessment of study.
- •Subjects that are pregnant and/or breastfeeding.
- •The subject has a known allergy or sensitivity to soaps, lotions, detergents, detanglers or fragrances.
- •Subjects if do not agree to limit sun exposure to affected areas such as face during prolonged sun exposure.
- •The subject has any other skin conditions i.e. cuts, scratches, ring worms, etc.
- •which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the subject.
- •The subject has any of the conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results.
- •The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data.
结局指标
主要结局
To evaluate the effectiveness of the test treatment(s) by assessing change in
时间窗: Improvement in | 1. skin elasticity and firmness through Cutometer Dual MPA 580 | 2. skin texture evaluated through Visioscan VC 20 Plus | 3. skin pigmentation and dark spots evaluated through Mexameter MX 18 | 4. skin colour parameters — L, a, b, and ITA evaluated through Skin Colorimeter CL 400 from baseline on Day 01 to post treatment assessments on Day 01 at T30 mins, Day 30 and Day 60, assessed within each treatment group and across treatment groups.
1. skin elasticity and firmness
时间窗: Improvement in | 1. skin elasticity and firmness through Cutometer Dual MPA 580 | 2. skin texture evaluated through Visioscan VC 20 Plus | 3. skin pigmentation and dark spots evaluated through Mexameter MX 18 | 4. skin colour parameters — L, a, b, and ITA evaluated through Skin Colorimeter CL 400 from baseline on Day 01 to post treatment assessments on Day 01 at T30 mins, Day 30 and Day 60, assessed within each treatment group and across treatment groups.
2. change in skin texture - Crow’s feet area wrinkles, fine lines, pores, roughness, dryness, smoothness
时间窗: Improvement in | 1. skin elasticity and firmness through Cutometer Dual MPA 580 | 2. skin texture evaluated through Visioscan VC 20 Plus | 3. skin pigmentation and dark spots evaluated through Mexameter MX 18 | 4. skin colour parameters — L, a, b, and ITA evaluated through Skin Colorimeter CL 400 from baseline on Day 01 to post treatment assessments on Day 01 at T30 mins, Day 30 and Day 60, assessed within each treatment group and across treatment groups.
3. change in skin pigmentation and dark spots
时间窗: Improvement in | 1. skin elasticity and firmness through Cutometer Dual MPA 580 | 2. skin texture evaluated through Visioscan VC 20 Plus | 3. skin pigmentation and dark spots evaluated through Mexameter MX 18 | 4. skin colour parameters — L, a, b, and ITA evaluated through Skin Colorimeter CL 400 from baseline on Day 01 to post treatment assessments on Day 01 at T30 mins, Day 30 and Day 60, assessed within each treatment group and across treatment groups.
4. change in skin colour parameters — L, a, b, and ITA, from baseline to post-treatment, within each treatment group and across treatment groups.
时间窗: Improvement in | 1. skin elasticity and firmness through Cutometer Dual MPA 580 | 2. skin texture evaluated through Visioscan VC 20 Plus | 3. skin pigmentation and dark spots evaluated through Mexameter MX 18 | 4. skin colour parameters — L, a, b, and ITA evaluated through Skin Colorimeter CL 400 from baseline on Day 01 to post treatment assessments on Day 01 at T30 mins, Day 30 and Day 60, assessed within each treatment group and across treatment groups.
次要结局
- 1. To evaluate the effectiveness of the test treatments by assessing change in skin dryness, redness, fine wrinkling/lines, coarse wrinkles, laxity, roughness and sallowness from baseline to post-treatment, within each treatment group and across treatment groups.(Day 01 (pre treatment), Day 01 T30 mins, Day 30, Day 60)
- 2. To evaluate the effectiveness of the test treatments by assessing change in skin wrinkles and fine lines from baseline to post-treatment, within each treatment group and across treatment groups.(Day 01 (pre treatment), Day 01 T30 mins, Day 30, Day 60)
- 3To evaluate the effectiveness of the test treatments by assessing change in skin pigmentation from baseline to post-treatment, within each treatment group and across treatment groups.(Day 01 (pre treatment), Day 01 T30 mins, Day 30, Day 60)
- 4. To evaluate the effectiveness of the test treatments by assessing change in skin hydration from baseline to post-treatment, within each treatment group and across treatment groups.(Day 01 (pre treatment), Day 01 T30 mins, Day 30, Day 60)
- 5. To evaluate the effectiveness of the test treatments by assessing change in skin glow from baseline to post-treatment, within each treatment group and across treatment groups.(Day 01 (pre treatment), Day 01 T30 mins, Day 30, Day 60)
- 6. To evaluate the effectiveness of the test treatments by assessing change in facial photographs from baseline to post-treatment, within each treatment group and across treatment groups.(Day 01 (pre treatment), Day 30, Day 60)
- 7. To evaluate the effectiveness of the test treatments by assessing change in product perception questionnaire regarding reduction in dark spots, skin appearance, skin hydration, skin texture, reduced fine lines and wrinkles from baseline to post-treatment, within each treatment group and across treatment groups.(Day 01 (pre treatment), Day 30, Day 60)
- 2. To evaluate the effectiveness of the test treatments by assessing change in wrinkle intensity, length, width & depth from baseline to post-treatment, within each treatment group & across treatment groups.(Day 01 (pretreatment), Day 01 T30 mins, Day 30, Day 60)
研究者
Dr Apeksha Merja
NovoBliss Research Private Limited