Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of the New Viviscal Professional Strength Oral Supplement in Females With Thinning Hair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02302053
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : November 26, 2014
Sponsor:
Collaborators:
Irish Response t/a Lifes2good
DeNova Research
Information provided by (Responsible Party):
Ablon Skin Institute Research Center

Brief Summary:

The New Viviscal Professional Strength is an oral food supplement specifically designed to promote hair 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 purpose of this clinical research study is to evaluate certain physiological effects of Viviscal compared to placebo in forty (40) female subjects, ages 21-75 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.


Condition or disease Intervention/treatment Phase
Hair Thinning Dietary Supplement: New Viviscal Professional Supplement Dietary Supplement: Placebo tablets Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy of the New Viviscal Professional Strength Oral Supplement in Females With Self-Perceived Thinning Hair
Study Start Date : February 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: New Viviscal Professional Supplement
New Viviscal Professional Strength Supplements. One tablet taken by mouth in the morning and one tablet in the evening with food for 180 days.
Dietary Supplement: New Viviscal Professional Supplement
The key ingredient is AminoMar C™ marine complex, an organic form of silica derived from Equisetum sp. (horsetail), vitamin C derived from Malpighia emarginata (acerola cherry), microcrystalline cellulose (E460), natural orange flavor, magnesium stearate, hypromellose, and glycerol. 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. The Viviscal supplement is compared to the placebo tablet which contains no active ingredients. One tablet is taken by mouth in the morning and evening with food.

Placebo Comparator: Placebo Tablet
Placebo tablets. One tablet taken by mouth in the morning and one tablet in the evening with food for 180 days.
Dietary Supplement: Placebo tablets
The placebo tablet contains no active ingredients. One tablet is taken by mouth in the morning and evening with food.




Primary Outcome Measures :
  1. Number of terminal hairs in the target area of the scalp. [ Time Frame: 180 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.

  2. Number of vellus hairs in the target area of the scalp. [ Time Frame: 180 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 vellus hair count.


Secondary Outcome Measures :
  1. Dino-Lite microscopic photographs for terminal hair diameter measurements in the target area. [ Time Frame: 180 days ]
    Dino-Lite Microscopic digital photographs to measure the diameter of the hair will be taken of the selected target area of each subject at each visit as specified under the Schedule of Procedures. Ten (10) terminal hairs in the target area will be randomly chosen throughout the area (not all from one direct area) and cut at the surface of the scalp thus not creating any bald patches. The hair diameter will then be measured at 1mm from the cut end of the hair. The ten (10) hair measurements will then be averaged to attain a median hair diameter for the target area.

  2. Quality of Life Questionnaire [ Time Frame: 180 days ]
    Questionnaire about the subjects general lifestyle and how their life is affected by thinning hair.

  3. Self-Assessment Questionnaire [ Time Frame: 180 days ]
    Questionnaire is the evaluation of the growth and qualities related to the subjects hair, nails and skin.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Females, ages 21-75 years of age.
  2. Clinically-determined general good health as determined by responses to the initial study assessment.
  3. 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).
  4. Females willing to maintain their normal hair shampooing frequency.
  5. Females willing to add the provided oral supplement to their current daily routine.
  6. 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.
  7. 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, 2 and 3.
  8. Females with Fitzpatrick I-IV photo skin types.
  9. Willingness to have digital photography of the target area and scalp for hair counts at Visits 1, 2 and 3.
  10. 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, 2, and 3.
  11. Willingness to maintain a consistent hair cut and hair color throughout the 6 month study period and to come to visits with clean (shampoo done in the morning prior to visit) and dry hair.
  12. 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 Visits 2 and 3)

Exclusion Criteria:

  1. Females with a known history of intolerance or allergy to fish, seafood or acerola.
  2. Females with any known allergy or sensitivity to any shampoo/conditioner.
  3. Females who are nursing, pregnant, planning to become pregnant during the study.
  4. Females with known stressful incident within the last six months (ie. death in family, miscarriage)
  5. Females who are participating on any clinical research study at ASIRC, DeNova Research or at another research center or doctor's office.
  6. 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.
  7. Females currently using the HairMax light treatment or other light therapy to treat thinning hair.
  8. Females who have regularly used Rogaine (Minoxidil) within the last 3 months.
  9. 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).
  10. 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.
  11. 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.
  12. Females with self-reported active hepatitis, immune deficiency, HIV or autoimmune disease.
  13. 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.).

Information from the National Library of Medicine

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): NCT02302053


Sponsors and Collaborators
Ablon Skin Institute Research Center
Irish Response t/a Lifes2good
DeNova Research
Investigators
Layout table for investigator information
Principal Investigator: Glynis Ablon, MD, FAAD Director Ablon Skin Institute Research Center
Principal Investigator: Steven Dayan, MD, FACS Director DeNova Research

Layout table for additonal information
Responsible Party: Ablon Skin Institute Research Center
ClinicalTrials.gov Identifier: NCT02302053     History of Changes
Other Study ID Numbers: ADHT-0213
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: November 26, 2014
Last Verified: November 2014

Keywords provided by Ablon Skin Institute Research Center:
Hair thinning, hair loss, alopecia, women, oral supplement

Additional relevant MeSH terms:
Layout table for MeSH terms
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical