Summary of Clinical Study

Introduction

Male pattern baldness, or thinning hair in women, particularly beyond the age of menopause, has certainly been recognized as a significant problem in the majority of the adult population.

Although there are many surgical techniques to try to correct these problems, surgery is expensive, requires a significant amount of time to heal, produces complications, and has results limited only to those areas on which surgery was performed. Wigs of various types have been used throughout the ages to compensate for this problem. Wigs are expensive and must be maintained, and certain techniques of weaving have been associated with medical problems.

There have been many different types of topical applications used in attempts to stimulate the growth of new hair, but typically, the results of these have been poor. Rogaine^®has certainly gained the most name recognition, but Rogaine^® is only successful in growing any type of hair in 29% of the population that uses it, and the hair typically is "baby hair," rather than mature hair. Because it is fine, immature hair that never achieves a good, normal length, the new hair that is produced all falls out within two weeks after discontinuing the use of Rogaine^®. The typical price of a one-month supply of Rogaine^® is between $50.00 and $100.00. To achieve any results, it must also be used twice daily, and this schedule must be maintained for the remainder of the person's life if he or she wants to continue deriving any benefit from the medication. Rogaine^® is a medication, and more side effects of this medication are now becoming apparent as long term use has occurred.

We saw a need for a 100% natural product what would achieve two significant goals. The first goal was to rapidly stop any excessive hair loss, thereby at least stabilizing the hair that an individual had when they began using Curetage, and to prevent further hair loss from occurring. This would stop the balding or thinning process. The second goal for the product was to achieve the growth of new mature hair that would be permanent.

Pre-Study Evaluation

Prior to initiating the formal study, an informal evaluation using two test subjects was carried out for twelve months. When satisfactory results were achieved, it was felt that a formal study should be undertaken.

Recruitment of Test Subjects and Selection of Applicators

In order to obtain objectivity, it was felt that no individual involved with the product or its development or marketing should be an applicator of the solutions; therefore, a licensed cosmetologist with forty years experience was selected as the test applicator. Twenty-six male volunteers, ranging in age from 29 to 68 years of age, were accepted into the test program. Two were completely bald except on the sides and nape area, and twelve had bald spots in the crown area along with receding hairlines. Ten were only thinning with receding hairlines.

Parameters of the Study

All twenty-six test subjects came to the clinic for initial interviews, photographs from four different angles, with the hair wet and dry, and initial interviews and treatments with Curetage products. They were instructed in the use and application of the products at home on a daily basis, and were instructed to return to the clinic in thirty days for another interview, clinical application, and more photographs.

The Materials Used

• Curetage Antioxidant/Botanical Cleanser I
• Curetage Purifier II
• Curetage Conditioner III
• Curetage Revitalizer IV
• Curetage Root Stimulator V

Method of Application

1. Wet hair, lather with Cleanser I, rinse. Lather again and let stand for two to three minutes. Rinse thoroughly.
2. Pour a small amount of Purifier II into hand and massage though wet hair vigorously. Rinse thoroughly with warm water.
3. Massage Conditioner III into wet hair and scalp for one to two minutes. Rinse thoroughly with warm water.
4. Apply Revitalizer IV until hair and scalp are saturated. Leave in. Do not rinse out!
5. Apply a small amount of Root Stimulator V to the scalp's thinning areas and massage. Leave in. Do not rinse out! Dry and style as usual. For best results, massage and apply Stimulator 2Xdaily.

Strength of Test Solutions

In order to determine the effectiveness of the formula at different strengths, four separate groups of test subjects utilized solutions using varying strengths of the active ingredients. The four groups used solutions of 25%, 50%, 70%, and 100% strength. After the first three months of the formal study, all test subjects were then provided with 100% strength solution to use during the last nine months.

Documentation

Prior to the initiation of the study, each test applicant was interviewed for a family history of baldness, illnesses, medication being taken, or other factors that might affect the health of the scalp or hair. A clinical examination was performed and photographs were taken from four angles. Throughout the year-long study, photographs were taken on a monthly basis along with a clinical examination and evaluation.

Results

The evaluation of the study was performed looking at multiple parameters.

All twenty-four test subjects with excessive hair loss completely stopped the hair loss within two to three weeks. In no case did excessive hair loss continue or resume.

Early growth of new hair, which was fine and immature, was noted in 100% of test subjects within eight to twelve weeks. That hair averaged 1/4 to 3/4 inches in length. The new hair began as a lighter more youthful color in cases (in men 30-45 years of age) where some test subjects' hair had darkened over the years. In one test subject - a sixty-two year old gentleman with silver hair - the new growth was noted to initially be black.

Maturity of the hair was characterized by thickening of the individual hairs, a change of color from gray to blonde to the natural color of the test subject, and an increase in length to the normal length of the individual's hair. Mature hair was noted to grow in 94% of all test subjects. Those individuals growing mature hair noted in 100% of all cases that the mature hair changed to the natural color of the test subject. At the conclusion of twelve months, new hair growth and maturation was still occurring. Thickening of existing hair was noted in 100% of all test subjects.

Throughout the entire study, there has been no indication of any allergy or hypersensitivity as a result of the application of the formulas.

94% of the test subjects expressed satisfaction with the results, and also expressed a desire to continue use of the product indefinitely.

Satisfaction

The rating by the examiners revealed good to excellent results in 84% of test subjects, fair results in 10% and poor results in 6%. It should be noted that even those with poor results did achieve the "baby hair" similar to that obtained with Rogaine^®, and excessive hair loss was stopped.

Conclusion

After the completion of the study, we felt that the two major objectives of the formulation - stopping excessive hair loss and the growth of new, mature hair - had been achieved in an extremely high percentage of test subjects. The satisfaction rating by the test subjects themselves, and the examiners' ratings, all demonstrated the superiority of these formulas compared to any other similar treatment commercially available. A table summarizing the results is below.

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