A Double Blind, Prospective, Placebo Controlled, Randomised, Three Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Collagen Peptide of Titan Biotech Limited in the Skin, Nail and Hair Health of Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- 1.Skin Improvement Questionnaire : Total Score of ≥20 by end of study
研究概览
简要总结
Study Design: DoubleBlind, Prospective, Placebo Controlled, Randomised, Three Arm Clinical Study. **Indication:**Skin, Nail and Hair Health InvestigationalProduct Test 1: Collagen Peptide(Fish Source) InvestigationalProduct Test 2: Collagen Peptide(Bovine Source) Comparator: Placebo StudyPopulation: 72 Subjects; Adultsbetween 18 and 45 years of age (both ages and all sexes inclusive). TreatmentDuration: 3 Months (90 Days)
RESULTS OF THE CLINICAL STUDY
Skin ImprovementQuestionnaire
BovineCollagen: 46% of Subjects in this treatment group have achieved a Score of >20in Skin Improvement Questionnaire in 90 Days. (Z = –0.39, p = 0.653 > 0.05).End Point NOT Achieved.
Fish Collagen: 100% of Subjects in thistreatment group have achieved a Score of >20 in Skin ImprovementQuestionnaire in 90 Days. (Z = 4.90, p = 0.000 < 0.05). End Point Achieved.
Placebo: 0% of Subjects in this treatment group haveachieved a Score of >20 in Skin Improvement Questionnaire in 90 Days. (Z =-4.69, p = 1.000 > 0.05). End Point NOT Achieved.
Fish Collagen vs Placebo: 100% ofSubjects in “Collagen (Fish) group†have achieved a Score of >20 whereas, 0% of subject in Placebo group achieved a score of >20 in Skin Improvement Questionnaire in 90 Days.
Bovine Collagen vs Placebo: 46% ofSubjects in “Collagen (Bovine) group†have achieved a Score of >20 whereas, 0% of subject in Placebo group achieved a score of >20 in Skin Improvement Questionnaire in 90 Days.
Bovine Collagen vs Fish Collagen: Only 46% of the subjects in “Collagen(Bovine) group†have achieved a Score of >20 in Skin ImprovementQuestionnaire in 90 Days, while 100% of subjects (i.e., all the subjects) haveachieved such reduction in “Collagen (Fish) groupâ€.
60 Second Hair CountTest
BovineCollagen : 50%of Subjects in this treatment group have achieved a reduction of 20% in 60 Second Hair Count Test in 90 Days. (Z = 3.88, p = 0.000 < 0.05). End Point NOT Achieved
Fish Collagen: 100% of Subjects in this treatment group haveachieved a reduction of 20% in 60 Second Hair Count Test in 90 Days. (Z = 4.90, p = 0.000 < 0.05).EndPoint Achieved
Placebo: 0% of Subjects in this treatment group haveachieved a reduction of 20% in 60 Second Hair Count Test in 90 Days. (Z = -4.69, p = 1.000 >0.05). End Point NOT Achieved.
Fish Collagenvs Placebo: 100%of Subjects (i.e., all thesubjects) have achieved 20% reduction in “Collagen (Fish) group†whereas, 0% ofsubject in Placebo group achieved a reduction of 20%in 60 Second Hair Count Testin 90 Days.
BovineCollagen vs Placebo: 50% of Subjectsin “Collagen (Bovine) group†haveachieved a reduction of 20% whereas,0% of subject in Placebo group achieveda reduction of 20% in 60 SecondHair Count Test in 90 Days.
BovineCollagen vs Fish Collagen: 50% of the subjects in “Collagen (Bovine) group†haveachieved a reduction of at least 20% in Hair Count Test score, whereas, 100% ofsubjects (i.e., all the subjects) have achieved such reduction in “Collagen(Fish) groupâ€.
Hair Growth Questionnaire
Bovine Collagen: 42% of Subjects in this treatment group have achieveda Score of >20 in Hair Growth Questionnaire in 90 Days.(Z = –0.78, p = 0.784 > 0.05). End Point NOT Achieved
Fish Collagen: 100% of Subjects in this treatment group have achieved a Score of >20in Hair Growth Questionnaire in 90 Days. (Z = 4.90, p = 0.000 < 0.05).EndPoint Achieved
Placebo: 0% of Subjects in this treatmentgroup have achieved a Score of >20 in Hair Growth Questionnaire in 90 Days.(Z = -4.69, p = 1.000 > 0.05). End Point NOT Achieved
FishCollagen vs Placebo: 100% of Subjects in “Collagen (Fish) group†have achieved a Score of>20 whereas, 0% of subject in Placebo group achieveda score of >20 in Hair GrowthQuestionnaire in 90 Days.
**BovineCollagen vs Placebo:**From Visit 1 to Visit 3: According to the result ofSingle Proportion Test, 42% of Subjects in “Collagen (Bovine) group†haveachieved a Score of >20 whereas, 0% of subject in Placebo group achieveda score of >20 in Hair GrowthQuestionnaire in 90 Days.
BovineCollagen vs Fish Collagen: From Visit 1 to Visit 3:According to the result of Two-Proportion test, the null hypothesis is rejectedat 5% level of significance (Z = –4.45,p = 0.000 < 0.05). Only 42% of thesubjects in “Collagen (Bovine) group†have achieved a Score of >20 in HairGrowth Questionnaire in 90 Days, while 100% of subjects (i.e., all thesubjects) have achieved such reduction in “Collagen (Fish) groupâ€
NailHealth Questionnaire
BovineCollagen: 42% of Subjects in this treatment group haveachieved a Score of >20 in Nail Health Questionnaire in 90 Days. (Z = –0.78, p = 0.784 > 0.05). EndPoint NOT Achieved
FishCollagen: 100% of Subjects in this treatment group haveachieved a Score of >20 in Nail Health Questionnaire in 90 Days. (Z = 4.90,p = 0.000 < 0.05).End Point Achieved
Placebo: 0% of Subjects in this treatmentgroup have achieved a Score of >20 in Nail Health Questionnaire in 90 Days.(Z = -4.69, p = 1.000 > 0.05). End Point NOT Achieved
FishCollagen vs Placebo: 100% of Subjects in “Collagen (Fish) group†have achieved a Score of>20 whereas, 0% of subject in Placebo Group achieved a score of >20 in Nail Health Questionnaire in 90 Days.
Bovine Collagen vs Placebo: 42% of Subjects in “Collagen (Bovine)group†have achieved a Score of >20 whereas, 0% of subject in PlaceboGroup have achieved a scoreof >20 in Nail HealthQuestionnaire in 90 Days.
Bovine Collagen vs Fish Collagen: 42% of the subjects in “Collagen (Bovine) group†have achieved a Scoreof >20 in Nail Health Questionnaire in 90 Days, while 100% of subjects(i.e., all the subjects) have achieved such reduction in “Collagen (Fish) groupâ€.
SafetyResults
No adverse event was reported in thisclinical study. The safety investigations also showed no clinical differencefrom baseline to end of the study.
Overall Study Conclusion: Overall,it is concluded that Fish Collagen waseffective in the improving skin, hairand nail health in 90 days. No adverse event was reported uponconsumption of both Bovine Collagen and Fish Collagen. Thesafety investigations also showed no clinical difference from baseline to endof the study. Based on the results of this Clinical Study Report,Fish Collagen Peptide of Titan Biotech Limited/Stalwart Nutritions Pvt. Ltd isrecommended as a safe and effective therapy in the improving skin, hair andnail health.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults between 18 and 45 years of age (both ages and all sexes inclusive) 2.Subjects with any skin type with a minimum of one concern i.Wrinkles ii.Dry, Dull Skin iii.Brittle Nails iv.Dry, Dull Hair v.Hair Fall, Breakage vi.Split Ends of the hair 3.Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.
- •4.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
排除标准
- •1.Subjects with known hypersensitivity to investigational product or its constituents.
- •2.Subjects who have skin condition that prevent proper examination or evaluation of study criteria.
- •3.Subjects who are on active treatments for skin and/or hair conditions.
- •4.Subjects who have dyed their hair in the last 60 days.
- •5.Subjects with immunucompromised state complications.
- •6.Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
- •7.Females who are pregnant or lactating or planning to become pregnant during the study period.
- •8.Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
- •9.Subjects, who in the opinion of the Investigator or the Medical Experts are not eligible for enrolment in the study.
结局指标
主要结局
1.Skin Improvement Questionnaire : Total Score of ≥20 by end of study
时间窗: 1.Skin Improvement Questionnaire : Day1,Day 45, Day 90 | 2.60 Second Hair Count Test: Day1,Day 45, Day 90 | 3.Hair Growth Questionnaire : Day1,Day 45, Day 90 | 4.Nail Health Questionnaire:Day1,Day 45, Day 90
2.60 Second Hair Count Test: Reduction of ≥20% by end of study
时间窗: 1.Skin Improvement Questionnaire : Day1,Day 45, Day 90 | 2.60 Second Hair Count Test: Day1,Day 45, Day 90 | 3.Hair Growth Questionnaire : Day1,Day 45, Day 90 | 4.Nail Health Questionnaire:Day1,Day 45, Day 90
3.Hair Growth Questionnaire : Total Score of ≥20 by end of study
时间窗: 1.Skin Improvement Questionnaire : Day1,Day 45, Day 90 | 2.60 Second Hair Count Test: Day1,Day 45, Day 90 | 3.Hair Growth Questionnaire : Day1,Day 45, Day 90 | 4.Nail Health Questionnaire:Day1,Day 45, Day 90
4.Nail Health Questionnaire: Total Score of ≥20 by end of study
时间窗: 1.Skin Improvement Questionnaire : Day1,Day 45, Day 90 | 2.60 Second Hair Count Test: Day1,Day 45, Day 90 | 3.Hair Growth Questionnaire : Day1,Day 45, Day 90 | 4.Nail Health Questionnaire:Day1,Day 45, Day 90
次要结局
- Not applicable(Not Applicable)