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

• Sponsor: Ablon Skin Institute Research Center
• Collaborator: Irish Response t/a Lifes2good
• Information provided by (Responsible Party): Ablon Skin Institute Research Center

Study Description

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

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Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.)

Contacts and Locations

Sponsors and Collaborators

Ablon Skin Institute Research Center

Irish Response t/a Lifes2good

Investigators

• Principal Investigator: Glynis Ablon, MD, FAAD; Director Ablon Skin Institute Research Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ablon G. A 3-month, randomized, double-blind, placebo-controlled study evaluating the ability of an extra-strength marine protein supplement to promote hair growth and decrease shedding in women with self-perceived thinning hair. Dermatol Res Pract. 2015;2015:841570. doi: 10.1155/2015/841570. Epub 2015 Mar 25.

• 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
• 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:

Alopecia; Alopecia Areata; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical