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 CLINICAL EVALUATION OF THE EFFICACY OF A 
SPIDER VEIN CREAM

1.0 OBJECTIVE
The objective of this study was to evaluate the efficacy of a spider vein cream in a 4-week take-home study with evaluations using a laser Doppler to determine blood flow changes.

 

1.1 Background
Laser Doppler flow meter allows for non-invasive measurement of skin blood flow and is well suited to measure stimulated blood flow as occurs during inflammation. The human epidermis contains no blood vessels but is nourished by diffusion from the dermis. The blood flow signal measured by laser Doppler instruments are an indication of the cutaneous perfusion. If an inflammatory response occurs such as a bruise of skin irritation the blood flow will normally increase. Once the inflammation subsides, the blood flow to the affected area returns to normal.
2.0 SPONSOR
Woodridge Labs
16217 Kittridge Street
Van Nuys, CA 91406		 2.1 Sponsor Representative
Denise Cosner
R&D Manager 
Product Quest Inc.
100 Moderage Blvd.
Holly Hill, FL 32117		  
3.0 CLINICAL INVESTIGATORS
Study Director
Annemarie E. Bisaccio, BA

Principal Investigator
Toni F. Miller, PhD, DABT, BCFE

 4.0 CLINICAL TESTING FACILITY
Essex Testing Clinic, Inc.
799 Bloomfield Avenue
Verona, NJ 07044		   5.0 STUDY DATES
Study Initiation
November 4, 1999

Final Evaluation
December 8, 1999

6.1 Ethical Conduct of the Study
This study was conducted in accordance with the intent and purpose of Good Clinical Practice regulations described in Title 21 of the U.S. Code of Federal Regulations (CFR), the Declaration of Helsinki and/or Essex Testing Clinic (ETC) Standard Operating Procedures.

ETHICS

 

6.2 Subject Information and Consent
This study was conducted in compliance with CFR Title 21, Part 50 (Informed Consent of Human Subjects). Informed Consent was obtained from each subject in the study and documented in writing before participation in the study. A copy of the Informed Consent was provided to each subject.
7.0 TEST ARTICLE
The test article used in this study was provided by:
Product Quest Inc.
100 Modernage Blvd.
Holly Hill, FL 32117

It was received on October 29, 1999 and identified as follows:

ETC Entry Nos. Qty. Rec'd Test Article I.D. Physical Description
6608.02   15 Tubes Formula N Light Yellow Cream
8.0 TEST SUBJECTS
Eleven (11) female subjects with spider veins, ranging in age from 35 to 58 years, were empanelled for the home use-testing procedure.

Each panellist read, understood and signed a written Informed Consent Form.
Each panellist completed a brief Medical History Form.

9.0 TEST PROCEDURE
All test panelists had at least two areas of spider vein on their legs. At the baseline visit each subject had a laser Doppler evaluation of the spider veins. One site was designated as the treated site and one as the control (non-treated) site. Subjects were given the test product (Formula N) and instructed to apply the product, twice a day, to the designated spider veins.

All subjects were instructed to return to the Testing Facility for laser Doppler evaluation after 1, 2, 3, and 4 weeks of use. If complete resolution of the spider veins was noted prior to Week 4, evaluations were discontinued at that time.

All subjects were give a Daily Diary with the following instructions for use:

1. Apply the test article to the designated bruise (on clean skin) once in the morning and once in the evening. 2. You may use your regular cleansing and moisturizing products, but do not try any new products. 3. Record each use (A.M. and P.M.) on the diary in black ink.
10.0 RESULTS AND DISCUSSION
Nine (9/11) subjects completed the study with Test Article: Formula N.
Two (2/11) test panelists (Subject Nos. 16 and 26) were discontinued due to personal reasons unrelated to the conduct of the study.

The subjects and the test sites used for control and treated evaluations are outlined below.

Subjects No. Treated Site Control Site
4
6
8
12
14
18
20
22
24		 Bottom
Left
Left
Left
Bottom
Back 
Left
Side
Bottom		 Top
Right
Right
Right
Top
Front
Right
Front
Top
10.1 Evaluation of Spider Veins
The mean laser Doppler values for the spider veins treated with Formula N, the control site, the percent change from baseline and the percent change from baseline and control are presented below.

Formula N.
Spider Vein Blood Flow Values
(% Change from Baseline)
Mean Blood Flow (Direct Contrast)
  Baseline Week 1 Week 2 Week 3 Week 4
Treated
(% Change from Baseline)		 2322 3077
(33%)		 3318
(52%)		 3337
(44%)		 3402
(47%)
Control
(% Change from Baseline)		 2465 3046
(23%)		 3043
(38%)		 3208
(30%)		 3310
(34%)
% Change from Baseline
and Control		   10% 14% 14% 13%
Formula N treated spider veins were associated with a 33%, 52%, 44% and 47% increase in blood flow after 1, 2, 3 and 4 weeks of product use compared with baseline. When these values were adjusted for the control and background blood flow, an increase in blood flow of 10%, 14%, 14% and 13% was observed during Week 1-4 respectively.

10.2 Discussion
The exact nature of the venous physiology associated with spider veins (spider reangiectasias) is not known. One of the theories includes the relaxation of the various wall tone. As this occurs, the rate and amount of blood flowing to the affected area may decrease. Laser Doppler image scanning has been successfully used to visualize and measure, non invasively, the flow of blood in the cutaneous microvasulature.
 

11.0 CONCLUSION
Under the conditions of this study, a clinically significant increase in blood flow was demonstrated during each of the 4 weeks in which spider veins were treated with Formula N. Laser Doppler photography and flowmetry clearly illustrated that Formula N helped to alleviate the visible appearance of spider veins.

Based upon these findings, it is concluded that Formula N helps to produce a clinically significant increase in blood microcirculation associated with spider veins.

 
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