Clinical Research

This section has been provided for educational purposes.  These are published European scientific tests based on samplings which are fewer in number than those recommended by the United States Food and Drug Administration.  These results are not guaranteed, and may differ in each individual case.

The first section presents summaries of some of the many studies done, and in some cases a link is provided at the end if you wish to see the full study.  At the end of the summaries is a list of other full studies that you may review.

European and American Testing on Kevis Products

Kevis Hair Lotion

1.  Double-blind placebo-controlled study with Kevis Lotion

In this experiment, which allows a casual interpretation for comparable groups, the effectiveness of Kevis in comparison with a placebo is revealed in a statistically significant manner:

1.  On the percentage of telogen hairs:  in 90 days it decreases by 16% in the Kevis group, and only by 6% in the placebo group;

2.  On the number of hairs counted in the three comb-stroke test:  (a) in the Kevis group it decreases by 56% in 60 days and by 59% in 90 days;  (b) in the placebo group it only decreases by 18% in 60 days and by 16% in 90 days.

3.  On the number of hairs pulled out in the traction test:  (a) in the Kevis group it decreases by 29% in 60 days and by 47% in 90 days;  (b) in the placebo group it only decreases by 5% in 60 days and by 7% in 90 days.

Hotel-Dieu, Marseille, France.  Director: Y. Privat.

2.  Les Nouvelles Dermatologiques 18-19 May. 1990 (Marseille, France).

Localization of 5-alpha-dihydr-testosterone in the hair follicle:  employment of monoclonal antibodies in the evaluation of the anti androgenetic activity of H.U.C.P.

RESULTS:  Investigation of the sections which had not been subjected to any treatment at all revealed the presence of high positivity for 5-alpha-DHT in the external follicle sheath and no apparent similar positivity in the cellular matrix.  However, in the telogen follicles of a series of sections, there was evidence of a certain amount of cytoplasmatic positivity for 5-alpha-DHT also in the matrix, always associated with the presence of 5-alpha-DHT in the follicle sheath.  Furthermore, a modest diffusion of the chromogen in between the cellular spaces was also noted and must be considered during interpretation of the prepared sections.  Observation of the sections obtained from the biopsies taken in the skin areas subjected to the action H.U.C.P. revealed an almost total absence of 5-alpha-DHT, both in the external sheath and the follicular matrix.  These findings were evident in all the subjects involved in the investigation.

University of Pavia, School of Dermatology, Milan, ltaly E. Berardesca, L. Miori, G. Rabbiosi, R. Venafra.

3.  Report of a treatment with topical solution of the product named "Kevis" used for subjects suffering from defluvium and/or alopecia

CONCLUSIONS:  After use for 60-90 days, the topical product applied in 43 male and female subjects suffering from slight or moderate degree alopecia has exerted an action which may be globally defined as favorable.  This positive evaluation is justified by the microscope finding that has evidenced a significant increase of hair in active growth phase (anagen phase) after application of the topical product.

The clinical evaluation has been expressed by the dermatologist about the effect of the treatment, globally considered:  this resulted to be very favorably in 26% of the cases versus 21% of the cases, where it was not possible to observe any effect.  In addition, in the remaining 59% of the cases a positive effect has been found, however modest its entity had appeared.

A more favorable evaluation of the topical drug was expressed by patients about "acceptance" of the product:  very good for 41% of the patients, with one unsatisfied patient only.  Same favorable evaluation expressed by patients about efficacy:  very good or good for 60% of the patients, while an unfavorable opinion was voiced by 3 patients (7%).

As to pruritus, the preparation has shown to be effective against this symptom, with statistically significant result, but three cases where drawbacks were present (onset or increase).  On the other hand, the preparation has shown to be poorly suitable for the treatment of pityriasis scaling:  patients who obtained improvement are counterbalanced by patients where a limited enhancement of scaling had appeared, so that the comparison did not result as statistically significant.

After performance of traction test, the number of subjects was halved who presented an intense or very intense defluvium, with a markedly significant improvement after treatment.  At last, the drawbacks connected to use of the topical product have appeared to be limited:  in 9% cases, increase of pityriasis scaling, and in 7% cases, onset or increase of pruritus.

University of Pavia, Dermatology Clinic July 1, 1985.  Director: Professor G. Rabbiosi

4.  La Medicina Estetica numero 4, 1986 (Editrice Salus Internazionale-Roma).  Action of a topical product on the scalp.

43 patients affected by telogen effluvium were subjected to treatment with a preparation for topical use, containing a mixture of natural mucopolysaccharides and a vasodilator.  The parameters evaluated were resistance to traction and trichogramme;  evolution of seborrhea, pruritus and dandruff;  trialist global objective judgment;  patient's global subjective judgment and his/her acceptance of the treatment.  From the statistical elaboration of the data obtained, it can be concluded that the topical product exerts a favorable action on defluvium and seborrhea;  while the response to pruritus is less evident and to pityriasis is irrelevant.

University of Pavia, Dermatology Clinic.  Director: G. Rabbiosi

5.  La Medicina Estetica number 3, 1988 (Editrice Salus Internazionale-Roma).  Double blind trial against placebo in the treatment of postpartum telogen effluvium.

A total of 50 women, aged between 20 and 35 years, mainly primiparae, affected by postpartum telogen effluvium, were divided into two randomized groups of 25 and treated, in double blind conditions, for a period of 36 days with a topical product indicated in the prevention of hair loss, compared with a placebo.  The results, analyzed by the trichogram method and traction test, demonstrated the product's efficacy in favoring the return to the physiological state, while the excellent tolerability confirmed its safety.

Maggiore Hospital of Lodi, Italy.  Professor Mario Goisis

6.  Evaluation of Kevis Thinning Hair Product-RB B67 122

A twelve-week study was conducted using males and females to determine subjects' perceptions regarding the performance and acceptability of a topical hair preparation designed for persons with thinning hair.  The product was generally perceived to provide a significant increase in hair body and fullness.  A significant number of subjects also rated the product as beneficial in improving hair texture and decreasing fallout rate.

Study Date:  July 5, 1988-November 22, 1988.  Study Site: Hilltop Research, Miamiville, OH;  Hilltop Research, Scottsdale, AZ.

7.  La Medicina Estetica number 1, 1988 (Editrice Salus Internazionale-Roma).  Report on the treatment with a topical preparation, Kevis, of volunteers affected by neoplasia and subjected to cycles of chemotherapy with cytostatic drugs.

In a clinical study performed in 61 patients subjected to chemotherapy with antiblastics (adriamycin and cis-platinum), a group of 32 patients received topical treatment with a new anti-alopecic preparation (KEVIS), while 29 patients who did not receive topical treatment were used as the control group.  Based on the resultant objective observations (photographs, traction test), it was statistically demonstrated that Kevis is active, first, in slowing down drastic hair loss caused by antiblastic therapy, and second, in aiding the conditions of the scalp to return to the normal physiological state at the end of the chemotherapy cycle.

"S. Anna" Province General Hospital, Como, Italy.  Director: Dr. Cosimo Epifani

Local Treatment of Androgenetic Alpecia with Kevis.  An international post-marketing survey on the results of clinical trials in patients treated for up to one year.

Foreword

In the treatment of androgenetic alopecia, systemic drugs with hormonal and/or vasodilating activity are generally devoid of any relevant therapeutical effect, other than those which are temporary or of scarce value, and represent a certain risk in terms of side effects.  On the contrary, a lotion for topical use, Kevis, has been reported in literature as a very safe and reliable product for such an indication (1, 2, 3, 4, 5).

The two main active ingredients contained in Kevis are: 1. H.U.C.P., a biological complex with a high content of high molecular weight hyaluronic acid and proteoglycans;  2. Thioglycoran, i.e. glycosamine-glycan sulphates (GAGS).  Thurfyl nicotinate (a well-known cutaneous vasodilator), Biotin, and Na-pantothenate are also contained in the formulation.

In a human pharmacology study, H.U.C.P. demonstrated its action in correcting the abnormal response of the sebaceous glands and hair follicles to the local effect of 5-alfa-dihydrotestosterone (5-alfa-DHT), which is considered as the major genetically programmed factor of the androgenetic alopecia process (Berardesca et al. 1990).  Furthermore, H.U.C.P. has demonstrated its efficacy in prolonging the anagen phase of the hairgrowth cycle which is normally shortened during the androgenetic alopecia process (9, 10).

Conclusions

According to the cyclical schedule of treatment adopted (1 vial/day for 4 weeks; 1 vial every other day for 7 weeks;  1 vial/week for 28 weeks), Kevis is effective in producing a relevant improvement in the androgenetic alopecia process as early as in the first 3-4 months, demonstrated by the significant reduction in the traction test values, and confirmed by the judgement expressed both by the dermatologists and by the patients.  At the same time, Kevis produces appreciable "aesthetic" effects, reported by the patients as an amelioration of appearance, manageability, and texture of the hair, and a general improvement in the look of fullness.

Apart from the very high rate of positive results in terms of general improvement, the interruption of the alopecic process, during treatment with Kevis for periods of up to one year, was apparent in practically the totality of the cases studied, thus representing a fact which is to be considered as one of the major and most important advantages offered by the use of this product.

Although the effects of treatment generally appear fairly soon, it must be noted that the best results are obtained progressively.  It is, therefore, advisable to continue treatment for the recommended period, even if there is a delay in obtaining evident results.

It is likely that the prompt and stable improvement in the results of both the traction test and overall condition (reported by the doctors), as well as the prompt and stable interruption of hair loss (reported by the patient), are related above all to the efficacy of H.U.C.P. and Thioglycoran (GAGS) in correcting the abnormal response of the sebaceous glands and hair follicles to the local action of 5-alpha-DHT.

In this regard, it is also important to point out that H.U.C.P. and Thioglycoran exert a benefic action in deep cutaneous hydration (14) and in prolonging the anagen phase of the human phase of the human hair growth cycle, which is shortened during the evolution of androgenetic alopecia (10).

Improvement of appearance, texture, manageability, and look of fullness of the hair is expectable as a consequence of the above mentioned primary action on the sebaceous glands and hair follicles (6), and should therefore become progressively evident based on the physiological duration of growth and regrowth of shedded hair, thanks to the activity exerted by Kevis.

Nevertheless, the prompt improvement of the same parameters also suggests a direct and synergic action of the product's active ingredients (H.U.C.P., Thioglycoran, Thurfyl nicotinate, Biotin and Na-pantothenate) on the structure of the hair, mainly in terms of keratin synthesis stimulation.

In conclusion, a long-term cycle of applications with Kevis is to be considered as a very reliable approach to the local treatment of androgenetic alopecia.  In fact, use of the preparation by both males and females, regardless of the actual alopecic pattern, was not only effective in a wide majority of cases (approx. 90%), but also practically devoid of any risk in terms of side effects.

Bibliography

1.  Vignini M., Speziali A., Fideli D., Donadini A.: Azione sul cuoio capelluto di un prodotto per uso topico. La Med. Estetica, Anno 10, n° 4, pp 97-100 (1986).

2.  Pelfini C., Fideli D., Speziali A., Vignini M.: Effects of a topical preparation on some hair growth parameters, evaluated utilizing a morphometric computerized analysis. Int. J. Cosm. Sc., 9, pp 1-11 (1987).

3.  Dallera F., Grazia D., Grossi F., Venafra R.: Studio in doppio cieco contro placebo nel trattamento del telogen effluvium del post partum: La Med. Estetica, Anno 12, n° 3, pp 1 129 (1988).

4.  Epifani C., Alberio F., Gini., Scognamiglio G., Venafra R.: Relazione sul trattamento col topico denominato "Kevis" su colontari affetti da neoplasia e sottoposti a cicli di chemioterapia mediante farmaci citostatici. La Med. Estetica, Anno 12, n° 1, pp 29-36, (1988).

5.  Privat Y.: A double-blind placebo-controlled study with Kevis Lotion. Trends in Human Hair Growth and Alopecia Research, Kluwer Academic Pub., pp 231-245 (1988).

6.  Berardesca E., Miori L., Rabbiosi G., Venafra R.: Valutazione dell'attività anti-androgena dell'H.U.C.P.. Abstract, lères Journées, Soc. Int. de Cosmétologie Médicale et Pharmaceutique, 18-19 Maggio 1990, Marsiglia.

7.  Lucky A. W.: The paradox of androgens and balding: where are we now? J. Inv. Dermatol. (1988).

8.  Sawaya M. E., Honig L. S., Garland L. H., Hsia S. L.:~ -5-3~-Hydroxysteroid dehydrogenase activity in sebaceous glands of scalp in male-pattern baldness. J. Inv. Dermatol. (1988).

9.  Cipriani C.: Evaluation of the trichology activity of a preparation containing GAGS and retinoic acid compared with a minoxidil solution. Congr. Int. di Dermatol., Berlino, (1988).

10.  Messenger et al.: Distribution of proteoglycans during the human hair growth cycle. Abstract, J. lnv. Derm., Vol. 92, n° 3, pp 540 (1989).

11.  Hamilton J.B.: Patterned loss of hair in man: types and incidence. Ann. NY Acad. Sci. 53, pp 708-728, (1952).

12.  Ludwig E.: Classification of the types of androgenic alopecia (common baldness) occuring in the female sex. Br. J. Dermatol., 97, pp 247-254 1977).

13.  Baden H.P.: Diseases of the Hair and Nails, pp 118. Year Book Medical Publishers Inc. (1987)

14.  Berardesca E., Gabba P., Borroni G., Rabbiosi G.: Assessment of the effects of a topical product containing glycosaminoglyclans in cutaneous hydration. lnt. J. Clin. Pharm. Res., Vlll (1), pp 69-73 (1988).

More Kevis information can be found on the pages below:

About Hair Loss
Kevis Hair Rejuvenation Program
Articles on Kevis Hair Rejuvenation 
Testimonials from Clients
U.S. Patent
Clinical Research for Physicians
The NaturoDoc Hair Comeback Program