Clinical Safety and Claims Substantiation for Biozhçm Cosmeceutical Skin Care Regiment Products “The RevitaCel System”

 

Synopsis of Clinical Studies

Prepared by Lawrence A. Rheins, Ph.D., Founder and EVP, DermTech International

 

Biozhçm Cosmeceuticals of 25651 Atlantic Ocean, Suite A-10, Lake Forest, CA contracted with Hill Top Research, Inc. of Milltown, NJ and DermTech International of San Diego, CA to conduct skin safety and efficacy studies for their RevitaCel Skin Care Product(s).  Both independent testing laboratories have extensive experience in conducting and interpreting safety and claims data for the Personal Care industry.  All clinical work conducted at both clinical testing laboratories was performed under Good Clinical Practices (GCP) as directed by current FDA guidelines.

 

Clinical Safety:

 

Products intended for repeated exposure to the face over a long period of time typically must be evaluated both for irritation and allergic potential prior to market launch.  The two industry standard studies that are usually performed are the “14 Day Cumulative Irritation Study”[1] and “Human Repeat Insult Patch Test” to assess both clinical skin conditions.[2]

 

The “14 Day Cumulative Irritation Study” involved 29 healthy subjects that received the Human Fibroblast raw active (i.e. solution of naturally secreted growth factors, as a by-product of growing normal human fibroblasts) under 100% occluded patch conditions for a period of 14 consecutive, approximately 24 hour applications to the left and right upper forearms.

 

The results of the study indicated that the test articles exhibited an irritation potential similar to the saline control.  As such, the test materials do not exhibit experimental irritation.

 

In addition, a 100 person Human Repeat Insult Patch Test (HRIPT) was conducted to evaluate the Human Fibroblast active potential to induce contact sensitization (e.g. skin allergy).  One hundred and eight healthy subjects were empanelled for the six-week study.  On Monday, Wednesday and Friday for three consecutive weeks, the test subjects received the Human Fibroblast active in its cosmetic base formulation applied to the upper left and right forearm under 100% occlusion.  Following three weeks of rest, the subjects returned to the laboratory on week six to receive the “challenge” application of the test and control articles.

 

The results of the study indicated that under the test conditions there was no evidence of contact sensitization.  It should be noted that the occluded conditions are exaggerated (10 x fold) far beyond the manufacturer’s directions for normal use.  The reported negative results strongly support the safety of this product for general use in the market place.  Further, all the other formula excipients, preservatives, etc., for the RevitaCel product regiments are all generally regarded as safe and effective (GRASE) with no attendant safety issues.  These particular ingredients, etc., are currently found in the marketplace in multiple personal care products.

 

Clinical Claims Substantiation:

 

The RevitaCel skin care product regiment purports to have qualities that reduce the appearance of fine lines, wrinkles, and skin elasticity effects.  Further, the product regiment enhances the skin’s moisturization with recommended use.

 

The double-blinded, efficacy study was conducted by DermTech International evaluating the RevitaCel skin care regiment, consisting of the Berryhydroxy Blast (an AHA marketed product) followed by the RevitaCel/Human Fibroblast product, and the addition of a marketed moisturizer; a three-step application process.  The applications occurred twice a day for a total of 90 days.  Test subjects were evaluated at baseline, day 45, and day 90.  Endpoints for clinical efficacy included: 35mm medical photography,[3],[4] performed at baseline and day 90.5  Nova Meter (model DPM 9003) evaporimetry measurements to assess changes in skin moisturization were conducted at baseline, and day 90.  Cutometer (Cutometer SEM 474) measurements to assess skin elasticity were conducted at baseline, and day 90[5].  The final endpoint, fine lines/wrinkles were evaluated using silicon replicas of the peri-occular region of the face.5  The resulting replicas were subjected to image analysis.  Silicon replicas were conducted at baseline, day 45 and day 90.

 

Forty-four healthy subjects (age 36-72) entered and completed the study.  During the study the subjects were prohibited form using any other skin care products, moisturizers, treatments, etc.

 

45 DAY RESULTS – DATA SILICON REPLICAS AND SCANNING IMAGE ANALYSIS – FROM “CROW LINES” AROUND EYES

	100%
	70%
	50%
	25%
	0%
						Wrinkle Reduction				Fine Line Reduction				Wrinkle Depth Reduction

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

HIGHEST PERCENTAGE OF RECORDED IMPROVEMENT

Ninety-five percent of the subjects demonstrated improvement in reduction of wrinkles, fine lines, and wrinkle depth when compared to baseline.  Although, individual results may vary, percent improvement of over 60% in wrinkle reduction, over 70% reduction in fine lines, and over 40% in depth of wrinkles can occur in individuals after just 45 days of use.

 

90 DAY RESULTS – DATA INCLUDES RESULTS OF SILICON REPLICAS, SKIN MOISTURIZATION, AND SKIN ELASTICITY CHANGES OCCURRING IN TREATED “CROW’S FEET”, FOREHEAD, AND CHEEKS

 

 

	100%
		70%
		50%
		25%
		0%
						Wrinkle Reduction				Fine Line Wrinkle				Moisturization Improvement				Elasticity Improvement

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

HIGHEST LEVEL OF IMPROVEMENT

 

 

At 90 day, 100% of the subjects demonstrated reduction in appearance of wrinkles, fine lines, wrinkle depth, increased moisturization, and skin elasticity with the treatment regiment.

 

Further, before and after 35mm photography between baseline and 90 days demonstrated the reduction in the appearance of fine lines, wrinkles, and wrinkle depth with twice/day treatment.

 

Although individual results may vary, the treatment at 90 days can produce greater than 70% reduction in the appearance of wrinkles and fine lines.  A 90% or better result is possible for increased facial moisturization, and greater than 50% elasticity improvement can occur following 90 days of twice per day regiment treatment. 

 

 

 

 

Clinical Photography Orientation

 

The described approach is one of the industry standards for aging/photodamage photography.1 , 2 A portrait studio was set up on the clinical facility of DermTech International.  It consisted of a “Smoke Gray” seamless paper for background and lighting.  A posing stool was set up about two feet from the background and 3 feet from the camera.  Footprints were taped to the ground and tape markers put on the walls and light stands to mark the right profile, right half profile, frontal, left half profile, and left profile positions for each subject.  This was to insure consistency among all subjects for the “before” and “after” shots.

 

A Hasselblad 501CM camera with Carl Zeiss 120mm, f$ macro lens was used with Fuji Provia Astia 120 color transparency film.  Exposure was 1/125 second at f22-1/2.  This f-stop was selected to maximize the depth of field.  Polaroid 679 color test prints were also used initially to determine the desired lighting and to confirm the correct exposure.  Lighting was uniform on both sides to minimize shadows.  Two lights were used to make sure that both profiles were shown equally.  Lighting was not changed for the “before” and “after” shots.  The lighting consisted to two Dynalite 4040 heads with 40” silver umbrellas, each set at 1,000 watt-seconds.  The lights were approximately two feet to each side of the camera, five and one half feet high and three feet from the subject.

 

Summary:

 

The Biozhçm Cosmeceutical RevitaCel skin regiment products are safe for general market use per the manufacturer’s instructions.  Further, when compared to baseline measurements, there were reductions in fine lines, wrinkles, and wrinkle depth at 45 days in a majority of test participants.  An additional 45 days of treatment demonstrated improvement in moisturization, and skin elasticity as well.  Standardized 35mm before and after photography provided compelling clinical data that the regiment could reduce the appearance of fine lines, and wrinkles, and depth of wrinkles.  On a final note, this skin care product regiment has been in the market place for over 3 months, with no reported significant adverse events, and with end user satisfaction for the marketed performance claims. 

 

 

45 DAY RESULTS – DATA SILICON REPLICAS AND SCANNING IMAGE ANALYSIS – FROM “CROW LINES” AROUND EYES

	100%
	70%
	50%
	25%
	0%
						Wrinkle Reduction				Fine Line Reduction				Wrinkle Depth Reduction