Science Nih to Beef Up Clinical Trial

• Periodical List
• J Clin Aesthet Dermatol
• v.5(xi); 2012 Nov
• PMC3509882

J Clin Aesthet Dermatol. 2012 Nov; 5(11): 28–34.

A Double-blind, Placebo-controlled Study Evaluating the Efficacy of an Oral Supplement in Women with Self-perceived Thinning Hair

Abstract

Objective: To assess the power of an oral supplement to increase pilus growth in women with thinning hair. Design: A randomized, placebo-controlled, double-blind study. Setting: One U.s.a. clinical site. Participants: Salubrious women anile 21 to 75 years with Fitzpatrick I to IV photo skin types with cocky-perceived thinning hair. Measurements: Subjects were randomized to treatment with the written report medication (N=10) or placebo (Northward=v) twice daily for 180 days. A 4cm² area of scalp was selected for hair counts performed after 90±7 and 180±vii days of handling. The chief efficacy measure out was the change in concluding and vellus hairs in each target expanse. The secondary measure was changes in a self-assessment questionnaire. Results: The mean (SD) number of final vellus hairs among placebo-treated subjects at baseline was 256.0 (24.1), remaining at 245.0 (22.4) and 242.2 (26.nine) after ninety and 180 days, respectively. The mean baseline number of terminal hairs in control-treated subjects was 271.0 (24.ii) increasing to 571 (65.7) and 609.half dozen (66.6) after 90 and 180 days, respectively (for each, p<0.001 vs. placebo). The mean number of vellus hairs amid placebo-and control-treated subjects did non significantly modify. Significantly more command-treated subjects perceived improvements in overall hair book, scalp coverage, and thickness of hair body after 90 days. Additional improvement after 180 days included hair shine, skin moisture retention, and pare smoothness. No adverse events were reported. Conclusion: The oral supplement assessed in this study safely and finer promotes significant hair growth in women with temporary hair thinning.

Androgenic baldness or male person-pattern baldness is the most common form of hair loss in men and less commonly a cause of hair loss in women.¹ More common causes of hair loss in women include medical conditions, such every bit hypothyroidism; medications including oral contraceptives; nutritional deficiencies; and physiological and emotional stresses.^{1 , ii} The causes of pilus loss in elderly women may be multifactorial.³ Among 100 adult women with diffuse pilus loss in one study, probable causes were determined to be psychological stress (xxx%), fever (33%), abortion and delivery (21%), trauma or surgical operations (13%), and hypothyroidism (10%).^four More than fifty percent of women had more than than one likely crusade of hair loss while a cause could not be adamant in six percent.

The effects of hair loss on cocky-image and self-esteem have been well documented. In i study, significantly macerated quality of life among adult men and women with various forms of hair loss was significantly correlated with symptoms of clinical depression,^five and the psychological bear on of pilus loss among women appears to be more severe than for men.^{six , 7} Consequently, a drug therapy that will safely and finer increase hair growth in women is highly desirable.

An oral compound consisting of proteins and glycosaminoglycans of marine origin was establish to have benign furnishings on women with lord's day-damaged skin. The results of two studies demonstrated improvements in the appearance of sun-damaged skin and increased pare thickness and elasticity. Brittle hair and nails returned to normal subsequently 90 days of treatment.^{8 , nine} Subsequent studies assessed the use of a like marine extract with the addition of other natural compounds (Viviscal^® Hair Nourishment Arrangement; Lifes2good, Inc., Chicago, Illinois) for the treatment of androgenetic alopecia. Several half-dozen-month, randomized, controlled studies have demonstrated the efficacy of Viviscal (the product used in these studies was originally marketed under the make proper name Hairgain^® [Parexel Medstat Equally, Lillestrøm, Norway]) for the treatment of androgenetic baldness.¹⁰ Similar results were accomplished in 8- and 12-month, open-label studies^{eleven , 12} Since these studies enrolled men, less is known nigh the use of Viviscal in women with thinning hair.

The objective of this randomized, double-bullheaded, placebo-controlled study was to test the hypothesis that the administration of this new oral supplement over a six-month period volition increment pilus growth in adult women with self-perceived thinning hair associated with poor diet, stress, hormonal influences, or aberrant menstrual cycles. Preliminary results of this study accept been presented elsewhere.¹³

METHODS

Subjects. The study enrolled women 21 to 75 years of age with Fitzpatrick skin types I to 4 who were in generally practiced health, just complained of self-perceived thinning hair. Participating subjects expressed their willingness to maintain a consistent shampooing frequency and cutting and color of their hair and agreed not to substantially modify their current diet, medications, or do routines for the elapsing of the study. Women of childbearing potential were required to use a medically accepted form of birth control during the study.

Subjects were excluded from participation if they had a history of allergy or intolerance to fish, seafood, acerola, whatever shampoos or hair conditioners; were nursing, pregnant, or planning to get pregnant during the written report; were participating in some other clinical research written report; had started the use of hormones for nativity command or hormone replacement therapy inside the prior six months; were currently undergoing a grade of treatment for thinning hair including drug or light therapy within the last three months; or used prescription drugs known to affect the hair growth bike within the last six months. Subjects with other hair loss disorders, such equally alopecia areata, scarring alopecia, and androgenetic alopecia; cocky-reported uncontrolled diseases, such as diabetes, hypertension, hyperthyroidism, or hypothyroidism; self-reported active hepatitis, allowed deficiency, human being immunodeficiency virus, or autoimmune disease; or any known active dermatological condition, which, in the opinion of the investigator, might place the subject at a greater adventure or interfere with clinical evaluations, were as well excluded.

Procedures. During the baseline visit, inclusion/exclusion criteria were reviewed and each subject provided informed consent and signed a photography release form. A medical history was obtained from each subject field, concomitant medications and lifestyle instructions were reviewed, and each subject underwent a physical exam and pregnancy testing. The scalp was examined to rule out the presence of any confounding scalp weather. The investigator selected an approximately 4cm² area of scalp along the frontalis bone at the junction of the frontal and lateral hairlines. This location was identified for farther assessments using a three-point location noted on each patient according to measurements taken from medial canthus, lateral canthus, and preauricular skin pit to the hairline junction and digitally photographed (Nikkon SLR 200/300 camera with a Canfield EpiFlash). Following the baseline visit, subjects returned for evaluation after ninety±7 and 180±seven days. At that fourth dimension, the physical exam, vital signs, and digital photographs were repeated. In improver, subjects completed self-assessment questionnaires (Tables 1) and were queried virtually possible adverse events.

Tabular array 1

Self-assessment questionnaire

Please review each of the parameters below and place a bank check mark (✓) for the most appropriate respond.
	Greatly INCREASED	MODERATELY INCREASED	SLIGHTLY INCREASED	NO CHANGE	SLIGHTLY DECREASED	MODERATELY DECREASED	Greatly DECREASED
i. Overall Pilus Volume	1 □	2 □	3 □	4 □	5 □	6 □	vii □
2. Scalp Coverage	ane □	two □	3 □	4 □	5 □	6 □	7 □
3. Thickness of Hair Body	1 □	2 □	3 □	four □	5 □	vi □	seven □
4. Softness of Hair Body	1 □	2 □	3 □	4 □	5 □	6 □	7 □
5. Pilus Smoothen	1 □	2 □	3 □	iv □	5 □	half dozen □	7 □
six. Number of Hairs Lost on Boilerplate Day	seven □	6 □	v □	4 □	3 □	two □	one □
7. Nail Force	1 □	two □	three □	4 □	5 □	6 □	vii □
eight. Boom Growth Rate	1 □	2 □	3 □	4 □	5 □	6 □	7 □
9. Peel Moisture Retentiveness	one □	2 □	3 □	4 □	v □	6 □	seven □
10. Facial Fine Lines and Wrinkles	i □	2 □	three □	iv □	5 □	half dozen □	7 □
11. Skin Softness	ane □	2 □	3 □	four □	5 □	half-dozen □	7 □
12. Pare Resiliency	seven □	6 □	5 □	4 □	iii □	2 □	1 □
13. Growth of Countenance Hair	i □	ii □	iii □	4 □	five □	half dozen □	7 □
14. Growth of Eyelashes	1 □	ii □	3 □	4 □	5 □	vi □	7 □
15. Skin Smoothness	1 □	2 □	3 □	4 □	5 □	6 □	vii □
16. Overall Pare Health	7 □	6 □	v □	4 □	3 □	2 □	1 □

Examination material. Subjects were randomized in double-blind fashion to receive the new oral supplement (Viviscal^® Maximum Strength) or placebo. Viviscal contains AminoMar C^™ marine complex, a proprietary alloy of shark and mollusk powder, an organic form of silica derived from Equisetum sp. (horsetail), vitamin C derived from Malpighia emarginata (acerola cherry), microcrystalline cellulose (E460), natural orange flavour, magnesium stearate, hypromellose, and glycerol. Placebo treatment consisted of inert tablets with similar appearance. Subjects were instructed to take one tablet of their assigned handling each morning and one tablet each evening with h2o following a repast.

Efficacy measures. The primary endpoint was the change in the number of final and vellus hairs in the target area of the scalp. The secondary endpoint was the modify in patient self-cess questionnaires post-obit treatment (Tables 1).

Safety measures. Rubber measures included spontaneous reports of adverse events and any adverse events disclosed during clinic evaluations and any changes noted during physical examinations.

Statistical analysis. The primary endpoint parameters measured during each evaluation were compared to baseline data using a paired t-test. Comparisons between agile and placebo treatments were fabricated using analysis of variance (ANOVA). Secondary endpoint parameters were compared using top box assay. Differences were considered significant at the level of p≤0.05.

Ideals. This study protocol and informed consent agreement were reviewed and approved by an institutional review board. Written consent was obtained from all participants prior to their participation in any report-related activities. This study was conducted in accordance with applicative guidelines for the protection of human subjects for inquiry equally outlined in the Usa Food and Drug Administration (FDA) 21 CFR Part 50, with the accepted standards for Good Clinical Practices and with the standard practices of the Ablon Pare Institute Research Center.

RESULTS

Efficacy. Subjects were randomized to receive the active medication (North=10) or placebo (Due north=5). The hateful (SD) age of subjects in the active and placebo treatment groups were 49.9 (8.5) years and 47.half dozen (17.0) years, respectively, and were not significantly different from i another. All subjects described themselves as Caucasian, except ane who was Hispanic.

At baseline, the hateful number of last hairs amid placebo-treated subjects was 256.0 (24.1) and remained at 245.0 (22.4) and 242.two (26.9) after 90 and 180 days, respectively (Tables 2). In contrast, the mean number of terminal hairs in the report medication-treated subjects was 271.0 (24.2) at baseline, increasing to 571 (65.7) and 609.6 (66.6) after 90 and 180 days, respectively (for each, p<0.001 vs. placebo) (Figure 1). Digital images reveal the visible improvements in two subjects treated with the new oral supplement (Figures ii–7).

Change in the number of vellus hairs. The use of a new oral supplement was associated with a meaning increment in the number of final hairs after 90 and 180 days of treatment.

*Denotes p<0.001 vs. placebo

TABLE 2

Changes in the number concluding and vellus hairs, mean (SD)

	Report MEDICATION (Due north=ten)			PLACEBO (N=5)
	Day 0	Day 90	Solar day 180	24-hour interval 0	Mean solar day xc	Twenty-four hours 180
Terminal hairs	271.0 (24.ii)	571.0 (65.7)a	609.5 (66.6)a	256.0 (24.1)	245.0 (22.four)	242.2 (26.9)
Vellus hairs	46.five (17.seven)	48.0 (sixteen.2)	46.5 (fourteen.4)	57.0 (32.one)	68.0 (21.4)	65.8 (16.vi)

The mean number of vellus hairs among placebo-treated subjects was 57.0 (32.1) at baseline and 68.0 (21.4) and 65.8 (16.half-dozen) afterwards 90 and 180 days, respectively (Tabular array ii). The mean number of vellus hairs among oral supplement-treated subjects was 46.5 (17.7) at baseline and 48.0 (16.2) and 46.five (14.iv) after 90 and 180 days, respectively.

With respect to subject cocky-assessments, significantly more than study medication-treated subjects perceived improvements in overall pilus volume, scalp coverage, and thickness of hair body after ninety days (Table 3). Additional improvements after 180 days included pilus smoothen, skin moisture retentivity, and skin smoothness.

Table iii

Changes in self-assessment questionnaire, mean (SD)

	Report MEDICATION (N=10)		PLACEBO (N=v)
	90 Days	180 Days	xc Days	180 Days
Overall hair book	2.8 (0.nine)a	i.8 (0.8)d	4.ii (0.four)	iii.8 (0.four)
Scalp coverage	2.half dozen (0.eight)b	1.5 (0.9)d	4.ii (0.four)	4.0 (0.0)
Thickness of hair torso	ii.9 (0.7)c	two.0 (0.9)d	four.two (0.iv)	4.0 (0.0)
Hair shine	two.9 (i.1)	ii.i (1.three)e	3.six (0.9)	iii.6 (0.9)
Pare moisture retentivity	3.6 (0.eight)	3.0 (0.viii)e	4.0 (0.0)	four.0 (0.0)
Skin smoothness	3.5 (0.vii)	3.0 (0.8)east	4.0 (0.0)	4.0 (0.0)

Safety. No adverse events were reported and no changes were observed during concrete examinations.

Give-and-take

When women with thinning hair were treated with the study medication, the mean number of terminal hairs in the target scalp expanse increased from 271.0 at baseline to 571 after three months of treatment and increased further to 609.6 after six months. Both were significantly greater than the mean number of terminal hairs amongst placebo-treated subjects at baseline (256.0), which remained unchanged throughout the study. These results support the hypothesis that Viviscal increases hair growth in women with thinning hair. These results are in understanding with studies demonstrating the drug'southward beneficial effect in the handling of sun-damaged skin in women^{8 , ix} and androgenetic alopecia in men.^{ten – 12}

In addition to objective measures of increased hair growth, significantly more women treated with the report medication perceived improvements in overall pilus book and thickness and scalp coverage after three months of treatment. Other improvements occurred afterwards three additional months of treatment including hair shine and skin smoothness and wet retentivity, suggesting boosted hair and skin improvements may occur with continued product apply. These results may stand for the start description of increased pilus growth in women associated with the use of a nutritional supplement. The results of work by others has demonstrated an oral supplement containing natural ingredients including marine-derived protein (shark cartilage) and fish oil (omega-three polyunsaturated fatty acids) significantly reduced pilus loss in women; all the same, it did not promote hair growth.^fourteen

Other natural products, such equally biotin and zinc, have also been advocated for the treatment of hair loss. Biotin is a water-soluble vitamin and an essential coenzyme for several of import enzymes¹⁵ while zinc is an essential micronutrient that is responsible for the normal functioning of hundreds of enzymes.^{16 , 17} The utilize of these agents for pilus loss is based on the observation that baldness is i of many consequences associated with biotin¹⁵ and zinc deficiencies.^xviii In one instance report, a kid with alopecia due to zinc deficiency was administered a zinc supplement and her hair loss stopped in 3 weeks^eighteen; still, the apply of a zinc supplement in a group of 15 patients with alopecia areata and depression serum zinc levels did not event in significant hair growth.^xix A literature search did not reveal whatever studies describing the utilise of biotin supplementation for the treatment of pilus loss.

Atomic number 26 deficiency is likewise believed to exist a crusade of hair loss in women, just literature reports are inconsistent. 1 report suggests women with iron deficiency status are at a risk of telogen pilus loss,²⁰ and among more than 5,000 women, a larger proportion with excessive pilus loss (59%) had low iron stores compared to women with moderate or no hair loss.²¹ Nevertheless, in another study, the incidence of iron deficiency was not increased among women with female pattern hair loss or chronic telogen effluvium.²² A literature search did not reveal any studies describing the use of iron supplementation for the treatment of hair loss.

Based on these promising results, ongoing research is studying how the AminoMar C extract affects hair cobweb formation within the hair follicle organ using an ex vivo culture model. Additional clinical studies designed to further assess the employ of Viviscal to increase hair thickness and hair counts using larger patient populations are currently under way. Together, these studies will help provide a more detailed understanding of the mechanism of this new drug to promote pilus growth and add to the existing trunk of clinical evidence.

CONCLUSION

The daily administration of a proprietary nutritional supplement significantly increased hair growth after 90 and 180 days. Self-perceived improvements after 90 days were increased after 180 days of boosted treatment, suggesting continued improvements may occur with ongoing handling. No adverse events were reported. These results may stand for the first description of increased hair growth in women associated with the use of a nutritional supplement.

Acquittance

Funding for this report was provided by Lifes2good, Inc., Chicago, Illinois. The writer acknowledges the assistance of Dr. Carl Hornfeldt during the preparation of this manuscript.

Footnotes

DISCLOSURE:Dr. Ablon received a research grant from Lifes2good, Inc., Chicago, Illinois. Funding for this written report was provided by Lifes2good, Inc.

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Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3509882/

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