Hindawi Publishing CorporationDermatology Research and PracticeVolume 2015, Article ID 841570, 8 pages Clinical Study
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

Glynis Ablon
Ablon Skin Institute Research Center, Manhattan Beach, CA 90266, USA Correspondence should be addressed to Glynis Ablon; [email protected] Received 10 November 2014; Revised 18 February 2015; Accepted 10 March 2015 Academic Editor: Bruno A. Bernard Copyright 2015 Glynis Ablon. This is an open access article distributed under the Creative Commons Attribution License, whichpermits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
An oral marine protein supplement (MPS) is designed to promote hair growth in women with temporary thinning hair (ViviscalExtra Strength; Lifes2good, Inc., Chicago, IL). This double-blind, placebo-controlled study assessed the ability of MPS to promoteterminal hair growth in adult women with self-perceived thinning hair associated with poor diet, stress, hormonal influences, orabnormal menstrual cycles. Adult women with thinning hair were randomized to receive MPS (𝑁 = 30) or placebo (𝑁 = 30)twice daily for 90 days. Digital images were obtained from a 4 cm2 area scalp target area. Each subject's hair was washed andshed hairs were collected and counted. After 90 days, these measures were repeated and subjects completed Quality of Life andSelf-Assessment Questionnaires. MPS-treated subjects achieved a significant increase in the number of terminal hairs within thetarget area (𝑃 < 0.0001) which was significantly greater than placebo (𝑃 < 0.0001). MPS use also resulted in significantly less hairshedding (𝑃 = 0.002) and higher total Self-Assessment (𝑃 = 0.006) and Quality of Life Questionnaires scores (𝑃 = 0.035). Therewere no reported adverse events. MPS promotes hair growth and decreases hair loss in women suffering from temporary thinninghair. This trial is registered with Identifier: NCT02297360.
various medical conditions [7]. Regardless of the cause, thepsychological impact of hair loss in women is well-known [8– Hair loss in women is often an overlooked and underappre- 11]. The psychological impact of hair loss is also more severe ciated condition that affects women almost as frequently as it for women than men.
affects men. In the United States, 40% of people with hair loss Nutritional deficiencies are also a known cause of hair are women and 40% of women have visible hair loss by age of loss [4] and may include inadequate intake of proteins, 40. Hair loss may begin in women as early as their teens [1] minerals, essential fatty acids, and vitamins [12]. Dietary zinc or 20s [2] and increases significantly with age. In one study, deficiency may be a cause of alopecia [13, 14]. Compared 6% of women aged under 50 years were diagnosed as having to normal controls, serum zinc concentrations were shown female pattern hair loss, increasing to 38% in subjects aged 70 to be significantly lower among women with female pattern years and over [3].
hair loss [15], which can be halted or improved with zinc Reasons for female pattern hair loss include medical supplements [14, 16]. Zinc supplements can increase hair conditions, medications, and physiologic or emotional stress growth in patients with alopecia areata [17]. Hair loss in [4–6]. A recent study of twins showed that significant factors women has also been reported to be associated with iron associated with hair loss in women included divorce or deficiency [12–14]; however, the results of a large controlled separation, multiple marriages, more children, longer sleep study indicate that the incidence of iron deficiency among duration, higher stress severity, smoking, higher income, and women with female pattern hair loss is not different than Dermatology Research and Practice women with no hair loss [15]. Deficiencies in other minerals within the last 6 months such as hormone-based contracep- such as selenium may also be a factor in hair loss [18]. Biotin tives, cyproterone acetate, aldactone/spironolactone, finas- is a water-soluble vitamin and essential cofactor for several teride, or other 5-alpha-reductase inhibitors; self-reported important enzymes [18]. Dietary deficiency of this important active hepatitis, immune deficiency, HIV, or autoimmune cofactor has also been associated with hair loss [13, 18, 19].
disease; self-reported uncontrolled diseases such as diabetes Currently, many medical treatments are available to men or hypertension; an active dermatologic condition which that are too dangerous for women or are unsafe for use in might place the subject at risk or interfere with the objectives women of child-bearing age, such as finasteride [20]. Viviscal of the study; other hair loss disorders, such as alopecia Extra Strength is an oral marine protein supplement (MPS) areata, scarring alopecia, androgenetic alopecia, and telogen specifically designed to promote hair growth in women effluvium; participating in any clinical research study; or suffering from temporary thinning hair. MPS is a proprietary nursing, pregnancy, or planning to become pregnant during blend of shark and mollusc powder derived from sustainable marine sources which provides essential nutrients to nourishhair naturally and improve the appearance of thinning hair. It 2.2. Test Material. Subjects were randomized in double-blind does not contain hormones or other drugs. MPS or the same fashion to receive the oral MPS (Viviscal Extra Strength Oral ingredients contained in MPS were initially shown to have Tablets; Lifes2good, Inc., Chicago, IL) or placebo. The key beneficial effects on hereditary androgenic alopecia in men ingredient in MPS tablets is AminoMar marine complex, [21] and photodamaged skin in women [22, 23]. The product Equisetum arvense sp. (horsetail which contains a naturally has been marketed in Europe for over 15 years.
occurring form of silica), Malpighia glabra (acerola cherry The purpose of this double-blind, placebo-controlled which provides vitamin C), biotin, and zinc. The AminoMar study was to further evaluate the ability of MPS to strengthen is composed of a proprietary blend of shark powder and and promote the growth of terminal hairs in adult women mollusc powder derived from sustainable marine sources.
with self-perceived thinning hair associated with poor diet, The placebo treatment consisted of inert tablets with similar stress, hormonal influences, or abnormal menstrual cycles.
We use the term hair loss to nonspecifically describe our study Subjects were instructed to take one tablet of their as- population as women who may notice their hair thinning signed treatment twice daily in the morning and evening even if it is not significantly dramatic enough for clinical following a meal. They were to maintain their normal hair diagnosis of true alopecia. True alopecia cases including care routine and use the same brand/type of hair care alopecia areata, scarring alopecia, androgenetic alopecia, products and maintain the same haircut, color, and style for and telogen effluvium as described in our exclusion criteria the study duration. Subjects with color-treated hair were also were not included. Since female pattern hair loss is also instructed to have the color treatment performed at the same characterized by changes in hair diameter associated with time interval prior to each visit (if the color treatment was hair follicle miniaturization [24, 25], the effect of MPS on done 1 week prior to Visit 1, it should be repeated 1 week prior hair diameter will also be measured. Finally, this study also to Visit 2). Subjects were instructed to wash their hair at home assessed the ability of MPS to decrease hair shedding.
24 hours in advance of each study visit.
2. Methods
2.3. Study Procedures. This study consisted of a baseline clinicvisit (Visit 1) and a follow-up visit at 90 days (Visit 2). A basic 2.1. Study Subjects. Women 21–65 years of age with Fitz- physical examination was performed at both visits which patrick photo skin types I–IV and self-perceived thinning included a basic body systems overview, vital signs, and scalp hair associated with poor diet, stress, hormone influences, or examination to rule out any confounding scalp conditions.
abnormal menstrual cycle were eligible for enrollment. Each Subjects were instructed to wash their hair at home 24 hours subject expressed her willingness to follow study procedures in advance of each study visit. During the clinic visit, each including maintaining their normal hair shampooing and subject had their hair washed with a commercial shampoo color treatment frequency and not substantially changing (Viviscal Gentle Shampoo; Lifes2good, Inc., Chicago, IL) over their current diet, medications, or exercise routines for the a sink containing a cheesecloth positioned to collect any shed duration of the study. Women of child-bearing potential were hairs which were collected and counted.
required to use a medically sound, nonhormonal form of During the baseline visit, an approximately 2 cm Γ— 2 cm birth control during the study.
(4 cm2) area of the scalp was selected along the frontalis Reasons for exclusion from study participation included bone where frontal hairline and lateral hairline meet (hairline a history of intolerance or allergy to fish, seafood, shellfish, junction). A three-point location was recorded based on or acerola; known allergy or sensitivity to any shampoo or measurements obtained from the medial canthus, lateral conditioner; a stressful incident within the last 6 months, canthus, and preauricular skin pit to the hairline junction.
such as the death of a family member; use of hormones Where these three points meet (anterior lateral triangle of for birth control or hormone replacement therapy during scalp), a target area 1 cm posterior into scalp hair was chosen.
the past 6 months; use of other therapies for hair growth The 4 cm2 target area was marked using a black fine-tip skin such as light therapy or minoxidil within the last 3 months; marker such that the three-point triangulation mark was in use of medications known to affect the hair growth cycle Dermatology Research and Practice Table 1: Changes in hair growth and hair diameter.
Mean terminal hair count (SD) Mean vellus hair count (SD) Mean terminal hair diameter, mm (SD) Mean shed hair counts (SD) Placebo, 𝑁 = 30 Mean terminal hairs (SD) Mean vellus hairs (SD) Mean terminal hair diameter, mm (SD) Mean shed hair counts (SD) βˆ—Repeated measures ANOVA across study days contrasts per treatment group; NS, not significant. Baseline versus 90 days.
Figure 1: Subject 42. The number of terminal and vellus hairs at baseline (left) increased significantly after 90 days of treatment (right). The4 cm2 target area of the scalp is shown in the middle and bottom rows.
Dermatology Research and Practice Figure 2: Subject 47. The number of terminal and vellus hairs at baseline (left) increased significantly after 90 days of treatment (right). The4 cm2 target area of the scalp is shown in the middle and bottom rows.
Phototrichograms were obtained of the scalp target area hairs and vellus hairs in the target area of the scalp at Visit at both visits using two-dimensional digital and macropho- 2. Terminal hairs were defined as short or long coarse hairs tographs (Canon SD 4500 IS and Nikon Coolpix 4300 found on the scalp with a cross-sectional diameter of 40 πœ‡M cameras, resp., with a 3GEN Dermlite Foto37 system). All or greater. Vellus hairs were defined as fine, short hairs with photographs were taken by the same staff member, in the a maximum cross-sectional diameter of less than 40 πœ‡M.
same location, and with the same lighting. Ten [10] terminal The secondary endpoints were changes in hair diameter, the hairs in the target area were randomly chosen throughout the number of shed hairs, and the responses to Quality of Life and area and cut at the surface of the scalp. Digital photographs Self-Assessment Questionnaires at Visit 2. Safety endpoints were obtained to measure hair diameter 1 mm from the cut were changes in physical examinations, scalp condition, and end of the hair (Dino-Lite Microscope; AnMo Electronics vital signs. Subjects were queried about potential adverse Corp., Torrance, CA). The hair diameter was measured and events at Visit 2.
used to obtain an average hair diameter for the target area.
2.5. Statistical Analysis. Descriptive statistics were obtained 2.4. Study Endpoints. Using phototrichograms, the primary for all variables. Tests of normality of continuous measures efficacy endpoint was the change in the number of terminal were made and data were examined for homogeneity of Dermatology Research and Practice Table 2: Self-Assessment Questionnaire results.
Placebo, 𝑁 = 30 (1) Overall hair growth (2) Overall hair volume (3) Scalp coverage (4) Thickness of hair body (5) Softness of hair body (7) Hair strength (8) Nail strength (9) Nail growth rate (10) Growth of eyebrow hair (11) Growth of eyelashes (12) Skin smoothness (13) Overall skin health βˆ—One-way analysis of variance; NS, not significant.
variance. Changes in baseline hair growth, hair diameter, hair 0.273) (Table 1). Consequently, the number of terminal hairs shedding counts with hair washing, Quality of Life responses, among MPS-treated subjects was also significantly greater and Self-Assessment Questionnaire responses were tested than placebo-treated subjects at Visit 2 (𝑓(1,58) = 200.4, using analyses of variance with repeated measurements. All 𝑃 < 0.0001) due to the greater increase among the MPS- statistical tests were two-tailed. Differences were considered treated subjects (MPS: D0:178.3 Β± 8; D90:235.8 Β± 18; placebo: statistically significant at the level of 𝑃 value of ≀0.05 D0:178.2 Β± 10, D90:180.9 Β± 18). Changes in the clinical appearance of two treated subjects at baseline and after 90days of treatment are apparent in Figures 1 and 2.
2.6. Ethics. This study protocol and informed consent forms Similarly, there was a significant increase in the number were approved by an institutional review board (IRB Com- of vellus hairs in MPS-treated subjects (𝑓(1,29) = 54.1, 𝑃 < pany Inc., Buena Park, CA). Each subject provided informed ) but not among the placebotreated subjects (𝑓(1,29) = consent prior to participating in any study-related activity.
, 𝑃 = 0.420) (Table 1). The mean number of vellus hairs in This study strictly adhered to all applicable guidelines for the MPS group at Visit 2 was again significantly greater than the protection of human subjects for research as outlined in the placebo group. The two groups were significantly different the United States FDA 21 CFR Part 50, in accordance with in the number of vellus hairs (𝑓(1,58) = 24.21, 𝑃 < 0.0001) due the accepted standards for good clinical practices and the to the significant increase among the MPS-treated subjects standard practices of Ablon Skin Institute Research Center.
(MPS: D0:19.57 Β± 2; D90:21.23 Β± 2; placebo: D0:19.8 Β± 2,D90:19.97 Β± 2).
3. Results
3.3. Secondary Endpoints. The two groups were significantlydifferent in the hair shedding counts following hair washing 3.1. Subject Enrollment. The study enrolled 60 women with a mean (SD) age of 48.6 years (10.0 years) (range, 24–65 years).
(1,58) = 4.51, 𝑃 = 0.038) due to significant decrease among the MPS-treated subjects (MPS: D0: 27.13 Β± 27; D90:16.47 Β± Subjects were randomized to receive treatment with MPS 14; placebo: D0:23.4 Β± 25, D90:21.87 Β± 21). There was no (𝑁 = 30) or placebo (𝑁 = 30) and all subjects completed the significant increase in terminal hair diameter among MPS- study. The race/ethnicity of subjects was Caucasian (𝑁 = 53; treated subjects (𝑓 88%), Hispanic (𝑁 = 6; 10%), and Asian (𝑁 = 1; 2%). There (1,29) = 11.42, 𝑃 = 0.434) or placebotreated were no significant differences between the two groups with (1,29) = 0.29, 𝑃 = 0.725) and the two groups were not significantly different from one another with respect to respect to age (MPS: 50.2 Β± 12 years; placebo: 46.9 Β± 9 years; terminal hair diameter (𝑓(1,58) = 0.674, 𝑃 = 0.415).
1,58 = 1.58; 𝑃 = 0.214) or race/ethnicity (MPS: Caucasian Subjects treated with MPS obtained significantly higher (𝑁 = 25; 83.3%); placebo: Caucasian (𝑁 = 28; 93.3%), df = 2, total scores on the Self-Assessment Questionnaire at Visit 2 (𝑓(1,58) = 8.27, 𝑃 = 0.006; MPS: 61.20 Β± 7; placebo: 55.57 Β± 8) with significant differences between the two groups on 7 of 3.2. Primary Endpoints. Among the MPS-treated subjects, 13 items including overall hair growth, overall hair volume, there was a significant increase in the mean number of ter- scalp coverage, thickness of hair body, hair strength, growth minal hairs from 178.3 (7.8) at baseline to 235.8 (18.4) at Visit of eyebrow hair, and overall skin health (Table 2).
2 (𝑓(1,29) = 362.0, 𝑃 < 0.0001) but not among placebotreated The MPS-treated subjects also obtained significantly subjects from 178.2 (9.6) to 180.9 (18.8) (𝑓(1,29) = 1.25, 𝑃 = higher total scores on the Quality of Life Questionnaire Dermatology Research and Practice Table 3: Quality of Life Questionnaire results.
Placebo, 𝑁 = 30 (1) I am embarrassed by my thinning hair.
(2) Because of my thinning hair, I avoid social gatherings.
(3) I do not like meeting newpeople as I feel they are judging me because of my thinning hair.
(4) I avoid going out during the day because of my thinning hair.
(5) My condition impacts my emotional state at work.
(6) I feel my thinning hair hasimpacted my ability to succeed in interviews.
(7) My condition has preventedmy participation in a sports activity.
(8) My condition impacts my self-esteem.
(9) My condition makes me feelself-conscious about my thinning hair.
(10) Because of my thinning hair,I fear being the center of attention.
(11) I feel my thinning hair isaffecting my personal relationships.
(12) Because of my thinning hair,I avoid being intimate with my partner.
(13) Because of my thinning hair,I feel less attractive to my significant other.
(14) Because of my thinning hair,I am less outgoing than I would like to be.
(15) Because of my thinning hair, I feel unattractive.
βˆ—Repeated measures ANOVA across study days contrasts per treatment group; NS, not significant.
(𝑓(1,58) = 4.61, 𝑃 = 0.035; MPS: D0:33.9 Β± 10; D90:26.9 Β± thinning hair. These changes were associated with improved 8; placebo: D0:34.0 Β± 11, D90:30.6 + 11). These differences hair quality including overall hair growth and increased hair were significant within each group (MPS: 𝑓(1,29) = 24.00, strength. There were no reports of adverse events.
𝑃 < 0.001; placebo: 𝑓(1,29) = 13.8, 𝑃 < 0.001); however, Other US studies have demonstrated the beneficial effects scores for MPS-treated subjects were significantly higher on of MPS when used by women with thinning hair. In a all 15 questionnaire items but only 10 for the placebo-treated placebo-controlled, double-blind pilot study, adult women subjects (Table 3).
with self-perceived thinning hair were randomized to receiveMPS (𝑁 = 10) or placebo (𝑁 = 5) twice daily [26].
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