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Viviscal Extra-Strength Formulation To Promote Hair Growth And Decrease Shedding In Women With Thinning Hair

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ClinicalTrials.gov Identifier: NCT02297360
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : November 21, 2014
Sponsor:
Collaborator:
Irish Response t/a Lifes2good
Information provided by (Responsible Party):
Ablon Skin Institute Research Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hair Thinning Dietary Supplement: Viviscal Extra-Strength Supplement Other: Placebo tablet Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Viviscal Extra-Strength Supplement
Viviscal Extra-strength tablets. One tablet taken by mouth in the morning and one tablet in the evening with food for 90 days.
Dietary Supplement: Viviscal Extra-Strength Supplement
The key ingredient of Viviscal Extra-Strength Supplement 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. 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 90 days.
Other: Placebo tablet
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: 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.

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


Secondary Outcome Measures :
  1. Dino-Lite microscopic photographs for terminal hair diameter measurements in the target area [ Time Frame: 90 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. Hair washing (shampooing) in clinic for hair shedding counts ( [ Time Frame: 90 days ]
    Subjects will be instructed to wash their hair at home 24 hours in advance of study visits 1 and 2. Subjects will then have their hair washed (shampooed) with Viviscal Gentle Shampoo in the office over a sink containing cheesecloth. The cheesecloth will be positioned to collect shedding hair. The number of hairs collected in the cheesecloth will be counted and recorded. Subjects will be allowed to dry and style their hair Subjects will have their hair washed and shedding hairs counted on Visits 1 and 2.

  3. Quality of Life Questionnaire [ Time Frame: 90 days ]
    Questionnaire about the subjects general lifestyle and how their life is affected by thinning hair.

  4. Self-Assessment Questionnaire [ Time Frame: 90 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

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Females, ages 21-65 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 and 2
  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 and 2
  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 and 2
  11. 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
  12. 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
  13. 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)

Exclusion Criteria:

  1. Females with a known history of intolerance or allergy to fish, seafood/shellfish 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 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): NCT02297360


Sponsors and Collaborators
Ablon Skin Institute Research Center
Irish Response t/a Lifes2good
Investigators
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Principal Investigator: Glynis Ablon, MD, FAAD Director Ablon Skin Institute Research Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ablon Skin Institute Research Center
ClinicalTrials.gov Identifier: NCT02297360     History of Changes
Other Study ID Numbers: FHOTC 0413
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: November 2014

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

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