NUTRAFOL's Synergen Complex Plus® is a formulation based on a patent-pending Synergen Complex®, a combination of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant, DHT-inhibiting and hormone-rebalancing properties - combined to synergistically combat the multiple underlying factors that compromise hair growth and health. Some key ingredients include Sensoril Ashwagandha, BCM-95 BioCurcumin, Saw Palmetto, EVNolMax 20% Tocotrienol/Tocopherol complex, gelatinized Maca, Astaxanthin, Bioperine (piperine), and Capsimax (capsaicin), all of which are bio-optimized and clinically tested.
Subjects to take four (4) Nutrafol Supplement capsules by mouth daily for 180 days with a substantial meal.

The placebo capsules contain no active ingredients. Subjects to take four (4) Placebo capsules by mouth daily for 180 days with a substantial meal.

During the 6 month open label extension all 70 subjects will receive NUTRAFOL's Synergen Complex Plus® which is a formulation based on a patent-pending Synergen Complex®, a combination of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant, DHT-inhibiting and hormone-rebalancing properties - combined to synergistically combat the multiple underlying factors that compromise hair growth and health. Some key ingredients include Sensoril Ashwagandha, BCM-95 BioCurcumin, Saw Palmetto, EVNolMax 20% Tocotrienol/Tocopherol complex, gelatinized Maca, Astaxanthin, Bioperine (piperine), and Capsimax (capsaicin), all of which are bio-optimized and clinically tested.
Subjects to take four (4) Nutrafol Supplement capsules by mouth daily for the six month extension with a substantial meal.

Hair Thinning

1. Females, age 40-65, who are perimenopausal, menopausal or post-menopausal. Perimenopausal is defined as increased variability in menstrual cycle length and defined as persistent difference of 7 days or more in length of consecutive cycles. Later stages include amenorrhea for 60 days or longer and/or vasomotor symptoms. These should have been present for at least 6 months prior to study. Menopause is defined as absence of menstrual bleeding for at least 12 months or 12 months status post complete Hysterectomy with Oophorectomy.

NUTRAFOL's Synergen Complex Plus® is a formulation based on a patent-pending Synergen Complex®, a combination of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant, DHT-inhibiting and hormone-rebalancing properties - combined to synergistically combat the multiple underlying factors that compromise hair growth and health. Some key ingredients include Sensoril Ashwagandha, BCM-95 BioCurcumin, Saw Palmetto, EVNolMax 20% Tocotrienol/Tocopherol complex, gelatinized Maca, Astaxanthin, Bioperine (piperine), and Capsimax (capsaicin), all of which are bio-optimized and clinically tested. The Nutafol supplement capsules are compared to the placebo capsules which contain no active ingredients. Four (4) capsules are taken by mouth once daily with a substantial meal.

Nutrafol Supplement Capsules

The placebo capsules contain no active ingredients. Four (4) capsules are taken by mouth once daily with a substantial amount of food.

Placebo Capsules

Ablon Skin Institute & Research Center

Efficacy and Safety of a Nutraceutical Supplement With Standardized Botanicals in Peri-menopausal and Menopausal Women With Thinning Hair

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating The Ability And Safety Of A Nutraceutical Supplement With Standardized Botanicals To Promote Hair Growth In Perimenopausal, Menopausal And Post-Menopausal Women With Self-Perceived Thinning Hair

Terminal hair is defined as coarse hair, short or long, found on the scalp with minimum cross-sectional diameter of 40 micrometers.

Vellus hair is defined as fine, short hairs found on the scalp with maximum cross-sectional diameter of 40 micrometers.

Total Hairs equals the sum of Terminal and Vellus Hairs in the Target Area

Terminal hair is defined as coarse hair, short or long, found on the scalp with minimum cross-sectional diameter of 40 micrometers. Vellus hair is defined as fine, short hairs found on the scalp with maximum cross-sectional diameter of 40 micrometers. Total Hairs equals the sum of Terminal and Vellus Hairs in the Target Area

Ten (10) terminal hairs just outside the border of the 2 cm x 2 cm area used for the Hair Check Hair Mass Index (HMI) will be randomly chosen (not all from one direct area) and cut at the surface of the scalp thus not creating any bald patches. The Dino-Lite Microscope will then be used to measure the diameter of each of the ten (10) hairs at 1mm from the cut end of the hair. All calibrations and measurement will be done at the setting of 230X. The ten (10) hair measurements will then be recorded on the Hair Diameter Log Form. All ten (10) diameters will be added together and then divided by 10 to attain an average hair diameter for the area and the average diameter will be recorded in the CRF. See Appendix IV.

Subjects will be instructed to wash their hair at home 24 hours in advance of study visits 1, 2, 3, 4 and 5. Subjects will then have their hair washed (shampooed) with a 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, 2, 3, 4 and 5. See Appendix V.

The treating investigator will complete this live assessment by circling the number on the scale that corresponds to the description that best fits the current global growth improvement and current hair quality Investigator Assessment Scale
3 Greatly increased
2 Moderately increased
1 Slightly increased 0 No change
1 Slightly worsened
2 Moderately worsened
3 Greatly worsened

Please complete the following questions by circling the number in the column which best describes your opinion for each characteristic.
Very Much (4) A Lot (3) A Little (2) Not At All (1) Not Relevant (0)
I am embarrassed by my thinning hair.
Because of my thinning hair, I avoid social gatherings.
I don't like meeting new people as I feel they are judging me because of my thinning hair.
I avoid going out during the day because of my thinning hair.
My condition impacts my emotional state at work.
I feel my thinning hair has impacted my ability to succeed in interviews.
My condition has prevented my participation in a sports activity.
My condition impacts my self esteem.
My condition makes me feel self conscious about my thinning hair.
Because of my thinning hair, I fear being the center of attention.
I feel my thinning hair is affecting my personal relationships.
Because of my thinning

Please complete the following questions by circling the number in the column which best describes your opinion for each characteristic; from +3 (greatly increased/improved) to -3 (greatly decreased/worsened)
Greatly Increased/Improved +3
Moderately Increased/Improved +2
Slightly Increased/Improved +1
No Change 0
Slightly Decreased/Worsened -1
Moderately Decreased/Worsened -2
Greatly Decreased/Worsened -3
Overall hair growth Overall hair volume Scalp coverage Thickness of hair body Hair amount Hair quality Hair color Hair shine Hair strength Softness of hair body Amount of new hair Hair growth rate Hair length Ease of styling Overall hair appearance Sleep Quality Overall Well-Being Nail strength +3 Nail Growth rate Growth of Eyebrow hair Growth of eyelashes Skin smoothness Overall skin health Energy levels Libido (Sex drive)
Please complete the following questions by circling the number in

Subject Treatment Satisfaction:
Please circle the number on the scale that corresponds to the description that you believe best fits your current satisfaction with the study treatment.
Subject Satisfaction Scale Description
3 Extremely Satisfied
2 Moderately Satisfied
1 Slightly Satisfied 0 No change
1 Slightly Unsatisfied
2 Moderately Unsatisfied
3 Greatly Unsatisfied

Questionnaire
Subject Hair Satisfaction Questionnaire:
Please check the box next to the description of your current state of hair health, which most accurately describes your current feelings of how satisfied you are with the amount and quality of hair on your scalp, including scalp coverage, volume and overall appearance.
Subject Satisfaction Scale Description
3 Extremely Satisfied
2 Moderately Satisfied
1 Slightly Satisfied 0 No change
1 Slightly Unsatisfied
2 Moderately Unsatisfied
3 Greatly Unsatisfied

Questionnaire This is a standardized scale and cannot be copied into this document.

Ablon Skin Institute Research Center

Nutraceutical Wellness Inc.

This is a six (6) month double-blind, randomized, placebo-controlled study with a six (6) month open-label extension to assess the safety and efficacy of Nutrafol® Women's Balance oral supplement in improving hair growth in perimenopausal, menopausal and post-menopausal female subjects with self-perceived thinning hair. After an initial screening period to determine eligibility, subjects will be randomly assigned to one of the following treatment arms: Nutrafol® vs. Placebo for the initial 6 months of the trial. All subjects (Nutrafol® and placebo groups) will receive the active treatment (Nutrafol®) throughout the latter 6-month open-label extension/follow-up period.

Double-Blind with a 6 month Open-Label Exension

Subjects to take four (4) Nutrafol Supplement capsules by mouth daily for 180 days with a substantial meal

Subjects to take four (4) Placebo capsules by mouth daily for 180 days with a substantial meal.

NUTRAFOL's Synergen Complex® is a patent-pending formulation of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant and DHT-inhibiting properties - combined to synergistically combat the multiple underlying factors that compromise hair growth and health. Some patented ingredients include Sensoril Ashwagandha, BCM-95 BioCurcumin, USPlus Saw Palmetto, EVNolMax 20% Tocotrienol/Tocopherol complex, Bioperine (piperine), Cynatine HNS (solubilized keratin), and Capsimax (capsaicin), all of which are standardized and clinically tested. the Nutrafol supplement capsules are compared to the placebo capsules which contain no active ingredients. Four (4) capsules are taken by mouth once daily with a substantial meal.

Nutrafol Supplement capsules

The placebo capsules contain no active ingredients. Four (4) capsules are taken by mouth once daily with a substantial meal.

Placebo capsules

Efficacy and Safety of a Nutraceutical Supplement With Standardized Botanicals in Women With Thinning Hair

A 6-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Ability and Safety of a Nutraceutical Supplement With Standardized Botanicals to Promote Hair Growth in Women With Self-Perceived Thinning Hair

The first primary efficacy parameter from the digital macrophotographs 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. Digital macrophotographs will be taken of the selected target area (1 cm by 1 cm) of each subject at each visit as specified under the Schedule of Procedures. The digital macrophotographs will show the five black colored markings on the scalp that define the target area. Digital macrophotographs will be performed using a Canon Power Shot G16 with 3GEN Dermlite FOTO Pro system.The macrophotographs are then read by the investigator to determine the terminal hair count.

The second primary efficacy parameter from the digital macrophotographs 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. Digital macrophotographs will be taken of the selected target area (1 cm by 1 cm) of each subject at each visit as specified under the Schedule of Procedures. The digital macrophotographs will show the five black colored markings on the scalp that define the target area. Digital macrophotographs will be performed using a Canon Power Shot G16 with 3GEN Dermlite FOTO Pro system. The macrophotographs are then read by the investigator to determine the vellus hair count.

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 just on the border of the 2 cm x 2 cm area used for the Hair Check HMI will be randomly chosen (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. All calibrations and measurement will be done at the setting of 230X. The ten (10) hair measurements will then be recorded in the source and averaged to attain a median hair diameter for the target area.

After attaining the target site (see target site selection section) and the four outer markings this will indicate the target area of 1 cm by 1 cm. Then the Hair Check 4-legged (2 cm x 2 cm) marking template will be placed around the triangulation point and target area. This 2 x 2 cm area will now be used for the creation of the bundle of hair to be measured for Hair Mass Index (HMI).

Questionnaire about the subjects and how their life is affected by thinning hair.

Questionnaire about the subjects general lifestyle and how their life is affected by thinning hair.

Investigator Hair Growth Global Improvement Scale:
The treating investigator will complete this live assessment by circling the number on the scale that corresponds to the description that best fits the current global growth improvement at delinated visits as indicated in the schedule of events. The blinded investigator will complete this assessment during the study at Day 90 and Day 180 visits.
Investigator Hair Quality Global Improvement Scale:
The treating investigator will complete this live assessment by circling the number on the scale that corresponds to the description that best fits the current hair quality at delinated visits as indicated in the schedule of events. Assessment grading is to be based upon the investigator's appraisal of hair brittleness, dryness, texture, shine, scalp coverage and overall appearance. The blinded investigator will complete this assessment during the study at Day 90 and Day 180 visits.

Questionnaire is the evaluation of the growth and qualities related to the subjects hair.

Acquisition of AD-tSVF via closed syringe microcannula harvest from subdermal fat deposits

Autologous AD-tSVF via enzymatic isolation/concentration via Centricyte 1000 closed system to create AD-cSVF

Re-suspension of AD-cSVF pellet in Normal Saline for deployment via IV

Nocturia

BPH With Urinary Obstruction

Prostatism

Prostate Inflammation

Use of closed syringe microcannula harvest of autologous AD-tSVF from subdermal adipose deposits to create a AD-cSVF

Microcannula Harvest Adipose

Use of Centricyte 1000 closed system digestion, incubation/agitation, and centrifugation to acquire a concentrated pellet of AD-cSVF

Centricyte 1000

Sterile Normal Saline deployment of AD-cSVF in suspension of 500cc in IV pathway

IV Sterile Normal Saline

Global Alliance for Regenerative Medicine-USA

Regenevita LLC

Use of Autologous Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Symptomatic Benign Prostate Hypertrophy

Use of Autologous Adipose-Derived Stem/Stromal Cells In Symptomatic Benign Prostate Hypertrophy

Report of minor and severe adverse effects caused by the procedures

Assessment of change from baseline (0) of frequency, urgency, pain, voiding time, and flow rate during voiding

Visual Analog Pain Scale (VAS) designated as levels pain 1-10

BPH Symptom Score change from baseline use American Urological Association Symptom Score Index change from baseline using Amercian Urological Association Symptom Score Index (AUA SI)

Change from Baseline of Measured International Prostate Symptom Score (I-PPS)

Robert W. Alexander, MD, FICS

Principal Investigator, Science

Terry, Glenn C., M.D.

Benign Prostatic Hyperplasia (BPH)

Oral administration - 160 mg twice daily.

Permixon® 160 mg

Tamsulosine Arrow LP

Placebo matching Permixon® 160 mg

Placebo matching Tamsulosine Arrow LP

Exploratory Study of L.S.E.S.r. (LipidoSterolic Extract of Serenoa Repens)(PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in Urinary Symptoms Related to BPH (Benign Prostatic Hyperplasia)

Exploratory Study of L.S.E.S.r. (PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in the Treatment of Urinary Symptoms Related to BPH; a Multinational, Multicentric, Randomised, Double Blind Parallel-group Prospective Study

"Inflammation biomarkers assay in patients suffering from Benign Prostatic Hyperplasia at Day 1, Day 30 and Day 90 :
Urine inflammation markers [mRNA (messenger RiboNucleic Acid) and proteins] on the first urine flow after digital rectal examination
Serum inflammation markers (C-Reactive Protein and Sedimentation Rate) "

Urinary symptoms assessed by International Prostate Symptom Score (I-PSS) (self-administered questionnaire)

Impact of symptoms on quality of life on the basis of the I-PSS quality of life question scored by the patient

Sexual activity assessed by the Male Sexual Function questionnaire (MSF-4) (self-administered questionnaire)

serenoa repens/inflamació

Efficacy and Safety of a Nutraceutical Supplement With Standardized Botanicals in Peri-menopausal and Menopausal Women With Thinning Hair

Efficacy and Safety of a Nutraceutical Supplement With Standardized Botanicals in Women With Thinning Hair

Use of Autologous Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Symptomatic Benign Prostate Hypertrophy

Exploratory Study of L.S.E.S.r. (LipidoSterolic Extract of Serenoa Repens)(PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in Urinary Symptoms Related to BPH (Benign Prostatic Hyperplasia)

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