To Evaluate the Effects of Viviscal Oral Supplements When Used by Females With Self-perceived Thinning Hair
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|ClinicalTrials.gov Identifier: NCT02288858|
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : November 14, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Hair Thinning||Dietary Supplement: Viviscal Oral Supplement Tablets||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|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|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Active Comparator: Test product
Viviscal Oral Supplement Tablets (as 512mg coated red-brown tablets in unbranded blister packs)
Dietary Supplement: Viviscal Oral Supplement Tablets
Tablet (512 mg)
Placebo Comparator: Placebo
Placebo Tablets (as 512 coated red-brown tablets in unbranded blister packs)
Dietary Supplement: Viviscal Oral Supplement Tablets
Tablet (512 mg)
- 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
- Quality of life questionnaires [ Time Frame: 6 months ]Quality of life questionnaires relating to perception of quality of hair growth and their wellbeing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02288858
|United States, Texas|
|Stephens Associates Inc.|
|Richardson, Texas, United States, 75081|
|Principal Investigator:||Ronald L Rizer, PhD||Stephens & Associates, Inc.|