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23% Better Skin In Just Two Weeks

Blue Horizon - Tuesday, February 11, 2014

Independent Lab Finds Special Skin Serum Delivers 23% Better Skin in Just 2 Weeks

BLUE HORIZON STEM CELL SKIN CARE TEST REPORT ON 20 HEALTHY SUBJECTS

Below is an English translation of the independent findings on 20 test subjects for Blue Horizon's Special Skin Serum.  You can read the report on laboratory letterhead in the original German, here: Stem Cell Skin Care Test Results in German.

Dermatest®, a top, independent German pharmaceutical and cosmetic test accreditation laboratory, deployed Dermatological Optical 3D Test – Norm DIN 4768 on the skin of 20 test subjects using Blue Horizon's Special Skin Serum.  At the end of two weeks, Dermatest ® found twice daily use of stem cell skin care safely delivered a 23 percent reduction in the appearance of fine lines, wrinkles, and scars.

CONCLUSION:

Improvement of the depth of wrinkles, after using the compound Special Skin Serum BC – UB0520 for two weeks was on average 23%.

6. ASSESSMENT OF THE TEST RESULTS

The 20 test subjects showed absolutely no harmful results during the two‐week clinical test of the compound Special Skin Care Serum BC – UB0520. There were no cases of unwanted skin changes in the test area.

The skin roughness of the twenty test subjects was examined both before and after two weeks of regular use of the compound Special Skin Care Serum BC – UB0520. 3D measurements of the epidermal “roughness” showed a visible improvement of 23 percent in just two weeks.

From a dermatological standpoint, we found that the subjects reacted very well to the
compound Special Skin Care Serum BC – UB0520 over the course of the two‐week test.
Improvements in skin roughness were observed, in accordance with DIN‐NORM 4768ff.

Key takeaway: test subjects showed an average of 23 percent improvement in skin roughness in just two weeks.

Read the full report below:

Medical Specialist’s Dermatological Survey Optical 3D Measurement of Skin Surface Quantitative Assessment of Surface Roughness of the Skin Calculation of the Skin’s Normed Roughness Parameters According to DIN 4768ff

Special Skin Care Serum BC – UB 0520 Test Parameters:

  • Client: BXXXXXXXXXXXXXs GmbH
  • Am MXXXXXXXXX9 Roetgen‐Aachen Germany
  • Special Skin Care Serum BC – UB0520
  • Test subjects: 20 female test subjects, all with healthy skin
  • Test period: two weeks
  • Testing area: face
  • Application Frequency: twice daily
  • Standards: Deutsche Industry Norm (DIN)
  • International Standards Organization (ISO)

1. OVERALL OBJECTIVE

The objective of this assessment was to test the product’s fitness for use at clinical
dermatological standards. Furthermore, the depths of lines and wrinkles were measured via optical 3D before and after usage. The data set is such that all candidates were dermatologically examined prior to the commencement of tests. The female candidates consulted with dermatologists regarding objective and subjective skin changes. Only candidates who showed no pathological skin conditions were selected for the test. Each candidate used the product UB0520 (Special Skin Serum) twice daily, once in the morning and once at night. Daily check‐ups with a dermatologist were available to subjects.

2. OPTICAL 3D MEASUREMENT WITH PRIMOS

2.1 INTRODUCTION

In‐vivo 3D measurement and evaluation of human skin is a precise and reliable technique to gauge medical and cosmetic treatment effects on the surface of human skin. This study
examines the medical and cosmetic dermatological effects to exacting standards. These effects can be measured via in‐vivo measurement or by creating skin replicas. Both methodologies are valid.

2.2 METHODS OF MEASUREMENT

The optical 3D measurement device PRIMOS uses an optical measurement methodology called digital stripe projection. The light projects a parallel stripe pattern onto the surface of the skin, which is recorded by a CCD camera and saved on the camera’s CCD chip.

3D measurement is achieved by observing minute differences in the level of the skin in the projection of the parallel stripes. These deflections can be used as qualitative and quantitative measurements of the profile of the skin. The CCD camera records and transmits data on the differences for evaluation by the measurement and evaluation computer. The assessment utilizes mathematical algorithms that were first developed for the precise optical measurement of mechanical pieces, and have now been co‐opted for use in the field of 3D skin measurement.

The combined process creates an exact 3D profile of the skin’s surface.  The optical 3D skin measurement device PRIMOS is precise and effective due to its use of both analog and digital signal processing, which combine with the stripe pattern to yield very fine measurements. The digital projection of light methodology is based on the development of digital micro‐mirror projectors, invented by Texas Instruments during the 1990s for quality control.

The compact version of PRIMOS consists of an optical gauge head that enables measurement of different areas of the skin. The PRIMOS equipment also includes:

  • An integrated micro‐mirror projector
  • Projection and recording optics
  • A CCD‐recording camera
  • A measurement and assessment computer
  • A device mount for free movement of the optical gauge head

PRIMOS pairs with a measurement and assessment software package that records and evaluates the surface of the skin. Each type of measurement has advantages and disadvantages. With the PRIMOS device, it is possible to measure the subject’s skin profile or skin replica entirely free of skin contact.

Methods that require skin contact are less accurate due to the pressure caused by application.  This pressure changes the 3D microstructure of the skin’s surface. Consequently, direct in‐vivo skin measurement can lead to skewed test results.

2.3 HIGHLY ACCURATE AREA RETRIEVAL

Visual inspection of skin is not sufficient to record changes accurately. Human skin is subject to constant circulatory system and autonomic nerve system movements. Furthermore, there is always a danger of subtle body movements during the collection of data, particularly during the examination of areas that are difficult to access. Such changes may lead to different levels of phase disturbances during the recording process (the phase of the exposure to light). The entire 3D data set could be rendered useless by strong movements. Normal movements can be identified fairly well in the data sets. However, sub‐microscopically small movement sequences of the examined skin are very hard to detect and can render the measurement data inaccurate.

The objective of 3D optical assessments is to identify the changes that are caused directly by cosmetic and medical treatments to the epidermis. Exacting quantitative and qualitative measurements before and after the treatment are important to draw authoritative conclusions.

We use the reference term of “roughness” to capture the total change in skin condition, even though facial skin roughness can vary greatly from area to area on the same subject. It is still the best constant measure for before and after results.

It is important to map the exact area of the skin being evaluated, as human epidermis has an uneven microstructure. The PRIMOS device is able to accurately measure position to within one tenth of a pixel. The measured area is 10 x 8 mm and the camera field is 640 x 480 pixels. This yields an accuracy of 1 μm. Highly accurate, real‐time retrieval of measurement data is matched to real‐time analysis of historical data.

Studying the effect of cosmetics on the smoothness of skin and eye wrinkles is very challenging. The initial photo captures a digital image of the subject’s skin in its original state for comparison to subsequent treatments. Each PRIMOS image layers on top of the next to create real‐time images of changes in the skin. Layering, combining and time‐shifting could create data issues.

Here is how PRIMOS deals with problems of inconsistency. Data mapping avoids data problems associated with minute differences in border overlays. We identify five distinctive structures in the reference area and map these with differently colored circles.

These circles are the constants between readings and create accuracy within two camera pixels. Companion software significantly increases measurement accuracy because it improves the capability to capture and analyze the tiniest of structural differences. This highly accurate matching procedure works by uploading the reference area of the skin to the left window and auto‐compares it to the right window via the companion software.
There are two methods for determining the change between the skin’s initial state and the
current measured state. The first method includes embedding profile cuts within two main
profiles. This can be done automatically and precisely thanks to highly accurate matching.

The second method quantifies and compares the roughness parameters from the reference profile and the measurement profile. Both methods can be used simultaneously.

2.4 MATERIALS USED

Silicon replicas are another viable method of measuring skin changes, using silicon‐based precision casting impression material (polysiloxan‐condensation‐networking, commonly known as molding silicon). The material is highly viscous, in compliance with DIN 13 913 A 2 and ISO 4823 (type 1, cat. B, color white).

The material has a pressure deformation in the range of 1 to 4%, with an average of under 2% in compliance with DIN 13 913. Dimensions vary less than 0.45%, in compliance with both DIN 13913 and ISO 48 23.

The impression compound is produced immediately prior to use. For every 12 ml of molding silicone, 2.5 cm of universal paste hardener is used. The compound is mixed for 45 seconds, after which it is spread evenly and lightly on the skin. The compound hardens after 2‐3 minutes, and the elastic impression is then carefully separated from the surface of the skin and secured on a glass top with a dissolvent‐free adhesive.

2.5 EVALUATION

By choosing the relevant point density for the x and y axes, a computer program renders a
realistic three‐dimensional image of skin texture on a color display. At the end of the study, the companion software is able to generate a highly accurate, real‐time analysis of skin changes.

The analysis covers the following steps:
1. The test derives a skin roughness profile through comparison of measurements before, during and after treatment.
2. Next, we compare the results to normal roughness parameters.

The PRIMOS companion software matches the structural changes of the epidermis
quantitatively. This happens by using the measurement parameters set by Deutsche Industry Norm (DIN) as well as the International Standards Organization (ISO). The calculations are based on the corresponding DIN norms. When necessary, long‐waved profile parts can be removed by using polynomials. When needed, wave and Gauss filters are used. The profile sections are arranged in a star pattern, and are used to determine the angular dependence of the roughness parameters in the direction of the strongest differences in height. The most common surface parameters used to analyze the skin structures are the following

  1. Ra: The average of the sum of all the profile ordinates within the tracing section (lm) after the digital filtering of form deviations and more rugged parts of the wave.
  2. Rz (DIN): The average of the five individual roughness depths of the adjacent tracing sections of the digitally filtered profile.
  3. Rq: The root mean square of the roughness profile deviation within the tracing section of the digitally filtered profile.
  4. Rmax (DIN): Largest occurring individual roughness depth Z1 of the filtered profile when calculating Rz.
  5. R3z: The arithmetic mean of the five individual roughness depths R3z1 to R3z5. The individual roughness depth is defined as the vertical distance between the third highest profile peek and the third lowest profile valley within the individual tracing section of the digitally filtered roughness profile. This comes with the qualifier that both vertical and horizontal minimum values have to be surpassed.
  6. R3zm: The deepest R3z within the tracing section in the occurring individual roughness depth.
  7. Rp: The distance between the highest point and the middle line within the tracing section of a digitally filtered profile.
  8. Rz (ISO): The sum of the average of the absolute heights of the five highest profile elevations related to the middle line as well as the five deepest depths related to the middle line.
  9. Rc: The sum of the absolute mean of the height of the profile peaks and depths of the profile valleys.
  10. Sm: The average of the distances between the intersections of the declining flanks of the profile elevations and the threshold value within the defined length lm. S=1/n S Si= (S1+S2+S3+Sn)/n.
  11. Wt: Height of the profile within the ripple tracing section I after filtering out the roughness.
  12. F.D. Fractal Dimension: 1 <FD< 3. More precise definition in e.g. “Surface Topography”, Vol. 1, Issue 2, June 88, p. 143ff. Simplified, it is possible to say that the smaller the value, the smoother the measured area.

2.6. LITERATURE

[1] S. Jaspers, G. Frankowski, G. Sauermann, D. Salter, U. Hoppe, H. Hopermann, R. Lunderstädt, J. Ennen: "Microtopometry Measurement of Human Skin in vivo by a new Digital Optical Projection System", Preprints 5th Congress of the International Society for Skin Imaging, Wien 1997.
[2] R. Lunderstädt, H. Hopermann, U. Hoppe: "Rauhigkeitsmessung und Texturermittlung der menschlichen Haut", 3. ITG/GMA Fachtagung "Sensoren und Meßsysteme", Bad Nauheim 1998.
[3] H. Hopermann, C. Hof: "In vivo Vermessung der Mikrotopographie der menschlichen Haut", AUTOMED '99, Darmstadt 1999.
[4] H. Hopermann, R. Lunderstädt: "Area Tracking in Topographical In Vivo Measurement Series of Human Skin by Displacement Vector Fields", Proceedings of SPIE Vol.4115, Applications of Digital Image Processing XXIII, pp. 283-293, San Diego 2000.
[5] T. Heinrich, R. Lunderstädt: "Quantification of Mechanical Properties of Human Skin in Vivo ", SPIE´s 46th Annual Meeting, Applications of Digital Image Processing XXIV, San Diego 2001.
[6] R. Lunderstädt, U. Müller: "Laserprofilometrie zur quantitativen Analyse der menschlichen Haut", Technisches Messen tm 59 (1992), S. 448-453.
[7] U. Müller, R. Lunderstädt: "Erstellung eines vollautomatisierten Meßplatzes zur Detektierung der Oberfläche der menschlichen Haut und rechnerorientierte Auswertung der Meßergebnisse", Tagungsband Fachtagung Automatisierung der TU Dresden, Dresden 1992.
[8] U. Müller, V. Schreiner, M.- C. Leneveu-Duchemin, W. Menßen, U. Hoppe "Microtopographical Changes of the skin surface regarding texture and roughness caused by treatment with an emulsion", IFSCC Congress, Venice 1994.
[9] M. Fiedler: "Quantitative Analyse der menschlichen Hautoberfläche mit Methoden der digitalen Bildverarbeitung", Dissertation, Institut für Automatisierungstechnik, Universität der Bundeswehr Hamburg 1994. (erschienen in: Verlag Shaker, R Informatik)
[10] A. Schröder, C. Hof: "Signalanalyse mit der Wavelet-Transformation am Beispiel der menschlichen Haut", Automatisierungstechnik at 47 (1999) Nr. 2, S. 55-62.
[11] C. Hof, R. A. Lunderstädt: "Analysis of the surface of human skin", Proceedings of SPIE Vol. 3784, Rough Surface Scattering and Contamination, pp. 175-184, Denver 1999.
[12] C. Hof: "Application of Wavelet- and Wavelet-Packet-Transform to Human Skin Data", Proceedings of SPIE Vol. 4474, San Diego 2001.

3. TEST SUBJECTS

The test group consisted of 20 adult females.

3.1 INCLUSION CRITERIA

• Women at least 40 years of age who have healthy skin in the test area.

3.2 EXCLUSION CRITERIA

• Severe or chronic dermatitis.
• Severe internal or chronic diseases.
• Ingestion of drugs that may alter the skin reaction (glucocorticoid, antiallergenic agents,
topical medication, etc.).
• The use of care products containing active agents 7‐ 10 days before the beginning of the test.
• Severe allergies or severe side effects from the use of cosmetic compounds.
• Significant sun exposure or tanning salon visits during the study.
• Known cancer sufferers.
• Pregnant or nursing.

3.3 TEST SUBJECTS

Nr. Name Sex Age Skin type
1 Il. Ac. w 61 dry
2 Ma. Bo. w 56 dry/sensitive
3 Ca. He. w 54 normal
4 Al. Kr. w 81 dry
5 Ur. Kr. w 57 dry
6 Gi. La. w 71 dry
7 An. Le. w 46 dry/sensitive
8 Si. Me. w 55 sensitive
9 Ge. Me. w 49 dry
10 Fr. Pe. w 51 dry/sensitive
11 As. Po. w 53 normal
12 Hi. Po. w 69 dry/sensitive
13 Ch. Ra. w 50 sensitive
14 Ed. Sch. w 52 mixed skin
15 Re. St. w 48 dry/sensitive
16 Ma. St. w 69 dry
17 An. Te. w 48 dry
18 Sy. v. Wi. w 53 oily
19 Ma. We. w 51 dry/sensitive
20 Br. We. w 56 dry

4. DERMATOLOGICAL EXAMINATIONS

1. Before the beginning of the test period:

All test subjects had visibly healthy skin in the test area. Pathological skin changes were not visible in any case.

2. During the test period:

None of the test subjects experienced pathological skin changes in or near the tested area during the four‐week test period. No test subject required a break from the test period, or dermatological treatment.

3. After the completion of the test period:

During the final dermatological examination after the completion of the test period, no
pathological changes of the skin were visible within the tested area of the test subjects. The
test subjects reacted very well to the formulation, and there were no undesirable changes to the skin.

5. RESULTS OF THE OPTICAL 3D MEASUREMENTS OF THE EPIDERMIS

5.1 SUMMARY OF THE CHANGES

The table below shows the Rz(DIN) values in the test area before and after treatment, and the difference between the two. Negative values indicate improvement, in this case a decrease in skin wrinkles.
Candidate‐Nr.
Before
Rz‐Values
μm
After
Rz‐Values
μm
Difference
of the
Rz‐values
μm
Relative Change in %
1 169.3 128.0 ‐41.3 ‐24.39
2 156.4 120.4 ‐36.0 ‐23.02
3 169.6 131.4 ‐38.2 ‐22.52
4 179.2 141.9 ‐37.3 ‐20.81
5 158.3 124.6 ‐33.7 ‐21.29
6 176.6 133.6 ‐43.0 ‐24.35
7 152.0 115.3 ‐36.7 ‐24.14
8 140.4 105.1 ‐35.3 ‐25.14
9 149.4 110.8 ‐38.6 ‐25.84
10 167.2 130.6 ‐36.6 ‐21.89
11 154.4 117.0 ‐37.4 ‐24.22
12 171.6 136.7 ‐34.9 ‐20.34
13 139.8 106.0 ‐33.8 ‐24.18
14 140.4 110.0 ‐30.4 ‐21.65
15 146.7 115.4 ‐31.3 ‐21.34
16 165.0 122.6 ‐42.4 ‐25.70
17 167.8 133.8 ‐34.0 ‐20.26
18 169.6 130.9 ‐36.7 ‐22.82
19 163.9 122.4 ‐41.5 ‐25.32
20 161.6 128.4 ‐33.2 ‐20.54

Average 160.0 123.2 36.7 ‐23.00
Minimum 139.8 105.1 ‐43.0 ‐25.84
maximum 179.2 141.9 ‐30.4 ‐20.26
12.1 10.5 3.5 1.89
Variance 146.4 110.9 12.6 3.56

Improvement of the depth of wrinkles after using the compound
Special Skin Serum BC – UB0520 for two weeks was on average 23 percent.

6. ASSESSMENT OF THE TEST RESULTS

The 20 test subjects showed absolutely no harmful results during the two‐week clinical test of the compound Special Skin Care Serum BC – UB0520. There were no cases of unwanted skin changes in the test area.

The skin roughness of the twenty test subjects was examined both before and after two weeks of regular use of the compound Special Skin Care Serum BC – UB0520. 3D measurements of the epidermal “roughness” showed a visible improvement of 23 percent in just two weeks.
From a dermatological standpoint, we found that the subjects reacted very well to the
compound Special Skin Care Serum BC – UB0520 over the course of the two‐week test.
Improvements in skin roughness were observed, In accordance with DIN‐NORM 4768ff.

Key takeaway: test subjects showed an average of 23 percent improvement in skin roughness in just two weeks.


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