Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-01-03 @ 3:50 PM
Study NCT ID:
NCT02288858
Status:
COMPLETED
Last Update Posted:
2014-11-14
First Post:
2014-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Effects of Viviscal Oral Supplements When Used by Females With Self-perceived Thinning Hair
Sponsor:
Irish Response t/a Lifes2good
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: