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
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Change in skin elasticity (R2) and firmness (RO)
研究概览
简要总结
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
详细描述
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.
The study is designed to complete with at least 75 evaluable subjects (25 per treatment group), accounting for potential dropouts or withdrawals during the study period.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining the written informed consent from the study participants. Subjects will be contacted telephonically by recruiting department prior the enrolment visit.
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.
Visit: 01 (Day 01, Week 00): Screening, ICD obtained, Enrolment, Baseline readings and post product usage readings.Visit 02 (Day 30, Week 04): Treatment Phase, Evaluations Visit 03 (Day 60, Week 08): Evaluations and Treatment Phase end | End of Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Age: 35 to 55 years (both inclusive) at the time of consent. 2) Sex: Adult male and female having Crow's feet area wrinkles, fine lines, facial dark spots.
- •3) Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit.
- •4) Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin ageing in last 3 months.
- •5) Subjects are not allowed to participate in any other study until this study is complete.
- •6) Subjects must be willing and able to follow the study directions and to return for all specified visits with the product.
- •7) Subjects must agree to record each use of the test products in the subject's diary card on daily basis.
- •8) Subjects must agree to record medication use during the study
排除标准
- •1) Subjects who are on steroids for last six months. 2) Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last three months.
- •3) Subjects who are on product which contains kojic acid, glycolic acid, niacinamide, alpha arbutin, Vitamin C and other skin ageing product.
- •4) Subjects with other dermatologic diseases whose presence or treatments could interfere with the assessment of study.
- •5) Subjects that are pregnant and/or breastfeeding. 6) The subject has a known allergy or sensitivity to soaps, lotions, detergents, detanglers or fragrances.
- •7) Subjects if do not agree to limit sun exposure to affected areas such as face during prolonged sun exposure.
- •8) 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.
- •9) 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.
- •10) The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data.
- •11) Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion.
研究组 & 干预措施
Topical Cream containing 0.1% Pinorox®
Mode of Usage: Apply a coin size (approximately 1g) amount of the test treatment to the face and gently massage it until fully absorbed.
Frequency: Apply the treatment twice daily Route of administration: Topical Dosage Form: Semisolid (Cream) Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight.
干预措施: Topical Cream containing 1% Pinorox® (Other)
Topical Cream containing 0.1% Pinorox®
Mode of Usage: Apply a coin size (approximately 1g) amount of the test treatment to the face and gently massage it until fully absorbed.
Frequency: Apply the treatment twice daily Route of administration: Topical Dosage Form: Semisolid (Cream) Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight.
干预措施: Placebo (Base Cream) (Other)
Topical Cream containing 1% Pinorox®
Mode of Usage: Apply a coin size (approximately 1g) amount of the test treatment to the face and gently massage it until fully absorbed.
Frequency: Apply the treatment twice daily Route of administration: Topical Dosage Form: Semisolid (Cream) Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight.
干预措施: Topical Cream containing 0.1% Pinorox® (Other)
Topical Cream containing 1% Pinorox®
Mode of Usage: Apply a coin size (approximately 1g) amount of the test treatment to the face and gently massage it until fully absorbed.
Frequency: Apply the treatment twice daily Route of administration: Topical Dosage Form: Semisolid (Cream) Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight.
干预措施: Placebo (Base Cream) (Other)
Placebo (Base Cream)
Mode of Usage: Apply a coin size (approximately 1g) amount of the test treatment to the face and gently massage it until fully absorbed.
Frequency: Apply the treatment twice daily Route of administration: Topical Dosage Form: Semisolid (Cream) Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight.
干预措施: Topical Cream containing 0.1% Pinorox® (Other)
Placebo (Base Cream)
Mode of Usage: Apply a coin size (approximately 1g) amount of the test treatment to the face and gently massage it until fully absorbed.
Frequency: Apply the treatment twice daily Route of administration: Topical Dosage Form: Semisolid (Cream) Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight.
干预措施: Topical Cream containing 1% Pinorox® (Other)
结局指标
主要结局
Change in skin elasticity (R2) and firmness (RO)
时间窗: from baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 mins, Day 30 and Day 60
evaluated through Cutometer Dual MPA 580 (R0 and R2) (change in %)
Change in skin texture i.e. Crow's feet area wrinkles, fine lines, pores, roughness, dryness, smoothness
时间窗: baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 mins, Day 30 and Day 60
evaluated through Visioscan VC 20 Plus, Crow's feet area wrinkles (score 0-3, score 0 indicate no wrinkles, score 3 indicate severe wrinkles), fine lines, pores, roughness, dryness, smoothness (measure in %)
Change in skin pigmentation and dark spots
时间窗: baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 mins, Day 30 and Day 60
evaluated through Mexameter MX 18 (change in %)
Change in skin colour parameters - L*, a*, b*, and ITA
时间窗: baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 mins, Day 30 and Day 60
evaluated through Skin Colorimeter CL 400, L\*, a\*, b\*, and ITA measure in change in %
次要结局
- Change in facial photographs(from baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 30 (±2 Days) and Day 60 (±2 Days),)
- Change in skin hydration(from baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 minutes, Day 30 and Day 60)
- Change in product perception questionnaire(from baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 30 and Day 60)
- Change in skin wrinkles and fine lines(from baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 mins, Day 30 and Day 60)
- Change in skin pigmentation(from baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 minutes, Day 30 and Day 60)
- Change in skin glow(from baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 minutes, Day 30 and Day 60)
- Change in skin dryness, redness, fine wrinkling/lines, coarse wrinkles, laxity, roughness and sallowness(from baseline on Day 01 (prior to the treatment usage) to post treatment assessments on Day 01 after 30 mins, Day 30 and Day 60)