A 3-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating The Ability Of Viviscal Extra-Strength Formulation To Promote Hair Growth And Decrease Shedding In Women With Self-Perceived Thinning Hair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Number of terminal hairs in the target area of the scalp.
研究概览
简要总结
The Viviscal Extra-Strength formulation is an oral food/dietary supplement specifically designed to promote hair growth for women suffering from temporary thinning hair. It does not contain hormones or drugs and has been marketed in Europe for over 15 years. Viviscal Extra-Strength is marketed as Viviscal Maximum Strength in some other territories.
The hypothesis of this clinical research study is that the ingestion of Viviscal Extra-Strength over a three (3) month period will strengthen and promote the growth of terminal hairs in female subjects, ages 21-65 years of age with self-perceived thinning hair associated with poor diet, stress, hormonal influences or abnormal menstrual cycles when compared to using the placebo tablet.
详细描述
The key ingredient of Viviscal Extra-Strength formulation is AminoMar C™ marine complex, Equisetum arvense sp. (horsetail), containing a naturally occurring form of silica), Malpighia glabra (acerola cherry) which contains Vitamin C, Biotin and Zinc. The AminoMar C™ is an active ingredient which has been trademarked and comprises of a proprietary blend of shark powder and mollusc powder. It is derived from sustainable marine sources. Viviscal provides essential nutrients to nourish hair naturally from within. Viviscal works in many ways over several months of use to improve the appearance of thinning hair.
- Nourishes the hair follicles
- Strengthens and promotes the growth of terminal hairs. Terminal hair is defined as coarse hair, short or long, found on the scalp with minimum cross-sectional diameter of 40 micrometers. Vellus hair is defined as fine, short hairs found on the scalp with maximum cross-sectional diameter of 40 micrometers.
- Supports the growth of hair where it has slowed down or temporarily stopped
- Hair becomes stronger, healthier and more vibrant
Ingestion of Viviscal Extra-Strength over a three (3) month period will strengthen and promote the growth of terminal hairs in female subjects, ages 21-65 years of age with self-perceived thinning hair associated with poor diet, stress, hormonal influences or abnormal menstrual cycles when compared to using the placebo tablet. The primary endpoints will be individual hair counts and favorable analysis using the Nikon CoolPix 4300 with 3GEN Dermlite Foto37 for phototrichogram analysis at the end of the three (3) month period. The secondary endpoints will be statistically significant decreased hair shedding counts with hair washing, favorable improvement in terminal hair diameter measured by the Dino-Lite Digital Microscopic and positive feedback on the Quality of Life and Self-Assessment questionnaires after three (3) months of Viviscal Extra-Strength ingestion.
All patients enrolled must be identifiable throughout the study. The Investigator will maintain a personal list of patient numbers and patient names to enable records to be found at a later date and the list will be stored in a locked cabinet. Subject numbers consist of a 2 digit number from 01 to 60. Patients will be randomized to active or placebo supplements (1:1 ratio) using a randomization table prepared prior to the start of the study by a non-participating staff member at the office of the Investigator. The study blind will not be broken until the end of the study. All test product and placebo will be labeled with subject numbers per the non-participating staff member. Subjects will be assigned a subject number in numerical order as enrolled. Randomization will occur by assignment to either Viviscal Extra-Strength supplement or placebo with 1:1 ratio. Subjects who terminate their study participation for any reason, regardless of whether study medication was used or not, will retain their randomization number.
Visit Procedures Pre-Study Procedures
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females, ages 21-65 years of age
- •Clinically-determined general good health as determined by responses to the initial study assessment
- •Females with self-perceived thinning hair associated with poor diet, stress, hormone influences or abnormal menstrual cycle as determined on initial study assessment by the Investigator (This will not include patients with medically diagnosed telogen effluvium)
- •Females willing to maintain their normal hair shampooing frequency
- •Females willing to add the provided oral supplement to their current daily routine
- •Females willing to not substantially change their current diet, medications, or exercise routines for the duration of the study. If a subject receives physician guidance during the study to change diet, medications, or exercise routine, the subject will need to notify the clinic as soon as possible
- •Females willing to undergo a brief physical exam to include height, weight, blood pressure, pulse, general physical findings and a scalp exam. The physical exam will occur at Visits 1 and 2
- •Females with Fitzpatrick I-IV photo skin types
- •Willingness to have digital photography of the target area and scalp for hair counts at Visits 1 and 2
- •Willingness to have ten (10) terminal hairs from the target area cut at the base of the scalp for microscopic hair measurements at Visits 1 and 2
- •Willingness to have their hair washed (shampooed) with Viviscal Gentle Shampoo over a sink containing cheesecloth for hair shedding counts at Visits 1 and 2
- •Willingness to maintain a consistent hair cut and hair color throughout the 3 month study period and to come to visits with clean (shampoo must be done 24 hours or more prior to the visit) and dry hair
- •Willingness of subjects who have color treated hair to have the color treatment performed at the same time interval prior to each visit (ie. If on Visit 1 the color treatment was done one week prior then the color treatment is expected to occur at a similar interval of one week prior to Visit 2)
排除标准
- •Females with a known history of intolerance or allergy to fish, seafood/shellfish or acerola
- •Females with any known allergy or sensitivity to any shampoo/conditioner
- •Females who are nursing, pregnant, planning to become pregnant during the study
- •Females with known stressful incident within the last six months (ie. death in family, miscarriage)
- •Females who are participating on any clinical research study at ASIRC or at another research center or doctor's office
- •Females who have recently (within the last 6 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using hormones for birth control or HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study
- •Females currently using the HairMax light treatment or other light therapy to treat thinning hair
- •Females who have regularly used Rogaine (Minoxidil) within the last 3 months
- •Females who have used prescription drugs known to affect the hair growth cycle within the last 6 months (e.g., hormone-based birth control for less than 6 months, cyproterone acetate, aldactone/spironolactone, Finasteride or any 5-alpha-reductase inhibitor)
- •Females suffering from other hair loss disorders, such as alopecia areata, scarring alopecia, androgenetic alopecia and telogen effluvium as determined on initial study assessment by the Investigator
- •Individuals with self-reported uncontrolled diseases (i.e. diabetes, hypertension, hyperthyroidism, hypothyroidism, etc.). Medical conditions that are under control with or without treatment will be considered on an individual basis by the Investigators
- •Females with self-reported active hepatitis, immune deficiency, HIV or autoimmune disease
- •Females having a known active dermatologic condition which, in the opinion of the examining Investigators, might place the subject at a greater risk or interfere with clinical evaluations (e.g., seborrheic dermatitis, psoriasis, atopic dermatitis, advanced skin cancer, etc.)
结局指标
主要结局
Number of terminal hairs in the target area of the scalp.
时间窗: 90 days
The first primary efficacy parameter from the phototrichogram will be the number of terminal hairs in the target area of the scalp. Terminal hair is defined as coarse hair, short or long, found on the scalp with minimum cross-sectional diameter of greater than 40 micrometers. Phototrichogram macrophotographs will be taken of the selected target area of each subject at each visit as specified under the Schedule of Procedures. Digital macrophotography will be performed using a Nikon Coolpix 4300 camera with a 3GEN Dermlite Foto37 system for scalp photography. The macrophotographs are then read by the investigator to determine the terminal hair count.
Number of vellus hairs in the target area of the scalp.
时间窗: 90 days
The second primary efficacy parameter from the phototrichogram will be the number of vellus hairs in the target area of the scalp. Vellus hair is defined as fine, short hairs found on the scalp with maximum cross-sectional diameter of 40 micrometers. Phototrichogram macrophotographs will be taken of the selected target area of each subject at each visit as specified under the Schedule of Procedures. Digital macrophotography will be performed using a Nikon Coolpix 4300 camera with a 3GEN Dermlite Foto37 system for scalp photography. The macrophotographs are then read by the investigator to determine the terminal hair count.
次要结局
- Dino-Lite microscopic photographs for terminal hair diameter measurements in the target area(90 days)
- Hair washing (shampooing) in clinic for hair shedding counts ((90 days)
- Quality of Life Questionnaire(90 days)
- Self-Assessment Questionnaire(90 days)