Hair ThinningNCT02288858
To Evaluate the Effects of Viviscal Oral Supplements When Used by Females With Self-perceived Thinning Hair
A study testing Viviscal Oral Supplement Tablets in people with Hair Thinning, run by Irish Response t/a Lifes2good at 1 site in United States.
Trial summary
The purpose of this multi-site, double-blind, placebo-controlled clinical study, conducted for Lifes2Good, is to evaluate certain physiological effects of Viviscal Oral Supplement compared to a placebo in female subjects with self-perceived thinning hair associated with poor diet, stress, hormonal influences, or… Read more about this study
- Who is it for?
- Ages 24 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hair Thinning
- What is being tested?
- Viviscal Oral Supplement Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females, ages 21-55 years of age.
- Clinically-determined general good health as determined by responses to the initial paperwork.
- Females with self-perceived thinning hair associated with poor diet, stress, hormone influences or abnormal menstrual cycle.
- 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.
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- 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, 3, and 5.
- Females willing to have a small dot tattoo applied to the scalp, a small area of hair shaved (approximately 1 cm2) to approximately 1 mm in length, remaining hair in that small area dyed black, and to have photographs performed. If the dot tattoo fades substantially by Visit 3, it may need to be re-inked.
- Females willing to wash their hair at the testing facility at Visits 2, 4 and 6 with the provided normal shampoo. Subjects may bring their own conditioner to use after shampooing.
- Individuals with Fitzpatrick I-III photo skin types, (Fitzpatrick IV may be enrolled at the discretion of the clinical investigator).
- Willingness to maintain a consistent haircut and hair color throughout the 6 month study period.
Who cannot join
- Females with a known history of intolerance or allergy to fish, seafood or acerola.
- Individuals with any known allergy or sensitivity to any shampoo/conditioner.
- Females who are nursing, pregnant, planning to become pregnant during the study.
- Females who are participating on any clinical research study at Stephens 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 to treat thinning hair.
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- Females who have regularly used Rogaine (Minoxidil) or Nizoral/Ketoconazole within the last 3 months.
- Females who have used prescription drugs known to affect the hair growth cycle within, 6 months (e.g., hormone-based birth control for less than 6 months).
- Females suffering from other hair loss disorders, such as alopecia areata, scarring alopecia or androgenetic alopecia.
- Females who have had hair transplants within 6 months of study start.
- 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 Investigator, might place the subject at a greater risk or interfere with clinical evaluations (e.g., seborrheic dermatitis, psoriasis, atopic dermatitis, advanced skin cancer, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-site, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effects of Viviscal Oral Supplements When Used by Females With Self-perceived Thinning Hair
The purpose of this multi-site, double-blind, placebo-controlled clinical study, conducted for Lifes2Good, is to evaluate certain physiological effects of Viviscal Oral Supplement compared to a placebo in female subjects with self-perceived thinning hair associated with poor diet, stress, hormonal influences, or abnormal menstrual cycles.
Viviscal is an oral food supplement specifically designed to promote the quality of existing hair growth and/or to promote new hair re-growth for women suffering from temporary thinning hair. It does not contain hormones, drugs, or industry by-products. Viviscal has been marketed in Europe for over 15 years. The key ingredient is AminoMar C - a protein rich compound of marine extracts blended with soluble silica and fortified with Vitamin C. Viviscal provides essential nutrients to nourish hair naturally from within. Viviscal works over several months of use to improve the appearance of thinning hair.
Read the detailed description
The purpose of this multi-site, double-blind, placebo-controlled clinical study, conducted for Lifes2Good, is to evaluate certain physiological effects of Viviscal Oral Supplement compared to a placebo in female subjects with self-perceived thinning hair associated with poor diet, stress, hormonal influences, or abnormal menstrual cycles. A total of 72 female subjects (36 subjects at the Dallas Research Center and 36 subjects at the Colorado Research Center) completed the study.
At day 0, prior to clinical procedures, subjects were assigned to 1 of the 2 treatment groups, Viviscal Oral Supplement or Placebo Tablets, based on the completely randomized study design that was generated with no input of subject information and conditions. During the course of the study, subjects consumed 1 tablet (512 mg) 3 times per day of the assigned test material, Viviscal Oral Supplement or Placebo Tablets, with water after food.
Clinical evaluations were conducted at visit 1 (day 0), visit 2 (day 2), visit 3 (3 months ± 2 weeks), visit 4 (2 days after visit 3), visit 5 (6 months ± 2 weeks), and visit 6 (2 days after visit 5). Subjects participated in the following procedures at the indicated time points:
- Scalp Examination At day 0, each subject's scalp was examined by the Sub-Investigator to rule out any confounding scalp conditions.
- Physical Examination A qualified nurse/nurse practitioner performed a basic physical examination of each subject at day 0, 3 months±2 weeks, and 6 months±2 weeks. The physical examination included a basic body systems overview, vital signs (blood pressure and pulse), respiration rate, temperature, weight, and height. Additionally, at the Colorado Research Center, the Sub-Investigator and qualified nurse practitioner examined each subject's scalp.
- Test Site Selection and Preparation At day 0, the examining Sub-Investigator selected a target area on each subject's scalp. To prepare the target areas for digital photography, subjects underwent shaving of the target areas at day 0, 3 months±2 weeks, and 6 months±2 weeks. Hair dyeing of the target areas was performed at day 0 and (if fading had occurred) at day 2, 3 months±2 weeks, 2 days after visit 3, 6 months±2 weeks, and 2 days after visit 5. Subjects underwent demarcation of the target areas with a small black dot tattoo at day 0 and (if fading had occurred) at 3 months±2 weeks and 6 months±2 weeks. For post-day 0 time points, tattooing procedures (if needed) were performed after the photography procedures.
- Digital Photography Macro photographs were captured of each subject's target area selected by the Sub-Investigator at all study visits.
- Shed Hair Collection Procedures At day 2, 2 days after visit 3, 2 days after visit 5, a clinician shampooed each subject's hair in a normal washing manner over a sink with securely fastened cheesecloth positioned to catch any hairs that were shed from the scalp. A clinician gently combed through the hair and rinsed any shed hairs from the comb onto the cheesecloth. Shed hairs found in the cheesecloth were counted and recorded.
- Questionnaire Each subject completed a quality of life questionnaire at baseline (day 0), 2 days after visit 3 and 2 days after visit 5 and a consumer questionnaire at 2 days after visit 3 and 2 days after visit 5.
- Daily Diary During the course of the study, subjects completed a daily diary to record product application times, any comments, and responses to a weekly question regarding their hair loss.
- Interviews At day 0, a portion of the subjects (at the Dallas Research Center) was selected to be interviewed and filmed. Film interviews were conducted for the pre-selected subjects at day 2 and 2 days after visit 5.
- Conditions
- Hair Thinning
- Being tested
- Viviscal Oral Supplement Tablets
- Keywords
- Hair thinning
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viviscal Oral Supplement TabletsDietary supplement
Tablet (512 mg)
| Study group | Role | What they receive |
|---|---|---|
| Test product | Active comparator | Viviscal Oral Supplement Tablets (as 512mg coated red-brown tablets in unbranded blister packs) Receives: Dietary Supplement: Viviscal Oral Supplement Tablets |
| Placebo | Placebo comparator | Placebo Tablets (as 512 coated red-brown tablets in unbranded blister packs) Receives: Dietary Supplement: Viviscal Oral Supplement Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair shedding rate
The numbers of scalp hairs shed at month 3 and month 6 when compared with baseline values.
Measured: 6 months
Hair fiber diameter
Mean vellus hair width change
Measured: 6 months
Secondary outcomes (1)
Quality of life questionnaires
Quality of life questionnaires relating to perception of quality of hair growth and their wellbeing.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startApr 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair ThinningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irish Response t/a Lifes2good
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stephens & Associates, Inc.
- Responsible party
- Sponsor
- Investigators
- Ronald L Rizer, PhD, Principal investigator, Stephens & Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288858
- Sponsor's protocol ID
- L2G-Stephens-Viviscal
- Status last verified
- Nov 2014
- First submitted
- 7 Nov 2014
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-site, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effects of Viviscal Oral Supplements When Used by Females With Self-perceived Thinning Hair
- ClinicalTrials.gov ID
- NCT02288858
- Acronym / sponsor ID
- L2G-Stephens-Viviscal
- Conditions
- Hair Thinning
- Keywords
- Hair thinning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Irish Response t/a Lifes2goodIndustry (pharma, biotech, devices)
- Collaborators
- Stephens & Associates, Inc.
- Study start
- Apr 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this multi-site, double-blind, placebo-controlled clinical study, conducted for Lifes2Good, is to evaluate certain physiological effects of Viviscal Oral Supplement compared to a placebo in female subjects with self-perceived thinning hair associated with poor diet, stress, hormonal influences, or abnormal menstrual cycles.
Viviscal is an oral food supplement specifically designed to promote the quality of existing hair growth and/or to promote new hair re-growth for women suffering from temporary thinning hair. It does not contain hormones, drugs, or industry by-products. Viviscal has been marketed in Europe for over 15 years. The key ingredient is AminoMar C - a protein rich compound of marine extracts blended with soluble silica and fortified with Vitamin C. Viviscal provides essential nutrients to nourish hair naturally from within. Viviscal works over several months of use to improve the appearance of thinning hair.
Detailed description
The purpose of this multi-site, double-blind, placebo-controlled clinical study, conducted for Lifes2Good, is to evaluate certain physiological effects of Viviscal Oral Supplement compared to a placebo in female subjects with self-perceived thinning hair associated with poor diet, stress, hormonal influences, or abnormal menstrual cycles. A total of 72 female subjects (36 subjects at the Dallas Research Center and 36 subjects at the Colorado Research Center) completed the study.
At day 0, prior to clinical procedures, subjects were assigned to 1 of the 2 treatment groups, Viviscal Oral Supplement or Placebo Tablets, based on the completely randomized study design that was generated with no input of subject information and conditions. During the course of the study, subjects consumed 1 tablet (512 mg) 3 times per day of the assigned test material, Viviscal Oral Supplement or Placebo Tablets, with water after food.
Clinical evaluations were conducted at visit 1 (day 0), visit 2 (day 2), visit 3 (3 months ± 2 weeks), visit 4 (2 days after visit 3), visit 5 (6 months ± 2 weeks), and visit 6 (2 days after visit 5). Subjects participated in the following procedures at the indicated time points:
- Scalp Examination At day 0, each subject's scalp was examined by the Sub-Investigator to rule out any confounding scalp conditions.
- Physical Examination A qualified nurse/nurse practitioner performed a basic physical examination of each subject at day 0, 3 months±2 weeks, and 6 months±2 weeks. The physical examination included a basic body systems overview, vital signs (blood pressure and pulse), respiration rate, temperature, weight, and height. Additionally, at the Colorado Research Center, the Sub-Investigator and qualified nurse practitioner examined each subject's scalp.
- Test Site Selection and Preparation At day 0, the examining Sub-Investigator selected a target area on each subject's scalp. To prepare the target areas for digital photography, subjects underwent shaving of the target areas at day 0, 3 months±2 weeks, and 6 months±2 weeks. Hair dyeing of the target areas was performed at day 0 and (if fading had occurred) at day 2, 3 months±2 weeks, 2 days after visit 3, 6 months±2 weeks, and 2 days after visit 5. Subjects underwent demarcation of the target areas with a small black dot tattoo at day 0 and (if fading had occurred) at 3 months±2 weeks and 6 months±2 weeks. For post-day 0 time points, tattooing procedures (if needed) were performed after the photography procedures.
- Digital Photography Macro photographs were captured of each subject's target area selected by the Sub-Investigator at all study visits.
- Shed Hair Collection Procedures At day 2, 2 days after visit 3, 2 days after visit 5, a clinician shampooed each subject's hair in a normal washing manner over a sink with securely fastened cheesecloth positioned to catch any hairs that were shed from the scalp. A clinician gently combed through the hair and rinsed any shed hairs from the comb onto the cheesecloth. Shed hairs found in the cheesecloth were counted and recorded.
- Questionnaire Each subject completed a quality of life questionnaire at baseline (day 0), 2 days after visit 3 and 2 days after visit 5 and a consumer questionnaire at 2 days after visit 3 and 2 days after visit 5.
- Daily Diary During the course of the study, subjects completed a daily diary to record product application times, any comments, and responses to a weekly question regarding their hair loss.
- Interviews At day 0, a portion of the subjects (at the Dallas Research Center) was selected to be interviewed and filmed. Film interviews were conducted for the pre-selected subjects at day 2 and 2 days after visit 5.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test product | Active comparator | Dietary Supplement: Viviscal Oral Supplement TabletsViviscal Oral Supplement Tablets (as 512mg coated red-brown tablets in unbranded blister packs) |
| Placebo | Placebo comparator | Dietary Supplement: Viviscal Oral Supplement TabletsPlacebo Tablets (as 512 coated red-brown tablets in unbranded blister packs) |
Who may qualify
- Ages
- 24 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Females, ages 21-55 years of age.
- Clinically-determined general good health as determined by responses to the initial paperwork.
- Females with self-perceived thinning hair associated with poor diet, stress, hormone influences or abnormal menstrual cycle.
- Females willing to maintain their normal hair shampooing frequency.
- Females willing to add the provided oral supplement to their current daily routine.
Key exclusion criteria (13 listed)
- Females with a known history of intolerance or allergy to fish, seafood or acerola.
- Individuals with any known allergy or sensitivity to any shampoo/conditioner.
- Females who are nursing, pregnant, planning to become pregnant during the study.
- Females who are participating on any clinical research study at Stephens 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viviscal Oral Supplement TabletsTablet (512 mg) | Dietary supplement | Placebo, Test product |
Primary outcome
Hair shedding rate
Time frame: 6 months
The numbers of scalp hairs shed at month 3 and month 6 when compared with baseline values.
Hair fiber diameter
Time frame: 6 months
Mean vellus hair width change
1 secondary outcome
Quality of life questionnaires
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald L Rizer, PhD principal investigator
Stephens & Associates, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viviscal Oral Supplement Tablets in people with Hair Thinning, run by Irish Response t/a Lifes2good at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair shedding rate (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2014.