Clinical Trials

Excerpts from clinical studies conducted from 1975 to 1996

Investigators:
Prof.L.CHASTRUSSE, Prof.R.SOUMIRIEU-MOURAT, Dr.C.AMBONVILLE, Dr.J.HOURCABIE.
Hôpital Tondu Pelligrin, Bordeaux.

Method:
Study conducted on 90 women (30 pregnant women without stretch marks, 30 pregnant women with stretch marks, 30 women with stretch marks who gave birth, compared with women not treated up to delivery (90 cases) for each population sample.

Results:
"…With a 92% response rate in prevention, 53% to 86% for curative response during pregnancy, 57% response rate in treatment post-partum stretch marks."
"… the treated area where the most significant improvement occurred was the breasts. Complete regression of stretch marks often occurred."

This clinical study was published in the French medical journal "Gynecologie", the official organ of the French Society of Gynecology and the International Federation of Pediatric and Adolescent Gynecology N°51975.


1976: "Clinical trial on Phytolastil in treatment of established stretch marks."

Investigators:
Prof. J.L. GRIGNON, Dr.J.BREGEROT
Dept. of Maxillofacial and Plastic Surgery, St.Antoine Hospital Centre, Paris.

Method:
A double-blind, placebo-controlled clinical study for 30 days on 50 women.

Results:
"…50 cases of established stretch marks treated with Phytolastil. We observed a slight improvement in 20% of cases, marked improvement in 24% of cases, and lastly, major improvement in 24% of cases."

Investigator:
Dr.J-S ELBAZ, Plastic Surgeon
Clinical expert certified to conduct clinical trials on medicinal products.

Method:
"A study conducted on 80 cases, 60 of which with double-blind placebo-controlled methodology."

Results:
"Clinical improvement in the general appearance of the stretch marked area and the adjacent area of skin - improvement in color, length and to a lesser extent, depth.
The best results were observed on recent-onset, post-partum, shallow stretch marks, not more than 3 or 4mm wide."

Investigators:
Prof.J.P.GAUTRAY, Dr.M.GUINGAMP
Dept. of Obstetrics-Gynecology, Hôspital Paris, Val-de-Marne.

M.MISKULIN, J.M.TIXIER, A.M.ROBERT, L.ROBERT
Laboratory for study of Biochemistry of connective tissue, Faculty of Medicine, University of Paris, Val-de-Marne.

Method:
This study was conducted with the cooperation of two research teams (page 465).

Group No.1
Clinical study conducted by a team headed by Prof.J.P.GAUTRAY, with double skin biopsies before and after treatment for 10 weeks on 16 women.

Results:
"…Thus, improvement in stretch marks was observed in the majority of cases." Clinically, improvement firstly involved the color of the stretch mark which clearly became lighter in all cases. Secondly, the improvement in size which appeared to decrease, especially the width. Improvement appeared to more marked or small stretch marks (breasts, shoulders) which appeared to regress.

Group No.2
Histological and biochemical study on biopsies of stretch-marked skin before and after treatment (10 weeks) by Prof.L.ROBERT's team.

Results:
"…After local treatment with plant extracts (Phytolastil), a major change was observed in fibroblasts biosynthesis in the dermis. In addition, objective clinical improvement was observed in most cases. It appears evident that the gross change observed in the dermis is the result of a change in fibroblast biosynthetic activity with treatment and its demonstration by skin biopsy method with uptake of radiolabelled precursors." It is to be noted that this clinical, histological and biochemical study was published in the French medical journal: "Le journal des Agrègès", Vol.13, No.11, Nov. 1980.

Investigator:
Dr.R.GABBAI - Dermatologist Consultant in the Paris Hospitals;
Member of the American Academy of Dermatology

Method:
Study conducted for 2 months on 17 women who gave birth less than 5 years ago. Clinical assessment and skin impressions recorded at Day 0 and Day 60.

Results:
"…Results show a statistically significant decrease of 11.3% in roughness, following the application of Phytolastil which corresponds to smoothing of the skin surface of stretch mark. This observation can be correlated with the sensation by touching: the skin feels smoother. Student's test performed on all subjects showed a highly significant decrease in the residual length of the stretch marks. This corresponds to an overall decrease in sharp edges of the skin relief as well as a major decrease in the number of skin folds in lesions."

Investigators:
Prof.A.VAROL, Dr.G.OZTURCK, Dr.S.CIGER, Prof.S.SOLAK
Dermatology Division, Medical School Hospital, Ege University, Turkey.

Method:
A simple clinical trial on Phytolastil conducted on 12 cases, for 8 weeks, on stretch marks related to multiple pregnancies (para : 3; obesity : 2; variation in weight : 6; puberty : 1).

Results:
"…Following application of Phytolastil, lightening in the color of the stretch marks was observed (75% of cases), attenuation of skin-depression (42% of cases), reduction in width of these marks (34% of cases) and a reduction in their length (17% of cases)." It should be noted that this clinical trial was officially presented, and a publication in the context of a Symposium chaired by Prof.A.LUTFU TAT, in Ankara, Turkey.

Investigators:
Dr.E.ORHON, Dr.I.KUCUK, Dr.I.ULGENALP, Dr.P.PAPUCCU
Hôpital GATA/KADIN Hst ve Dogum ABD Baskani, Turkey.

Method:
44 primipara (first pregnancy) without stretch marks and multipara with stretch marks were followed from weeks 12 to 16 of pregnancy up until delivery to study Phytolastil's efficacy in the prevention and treatment of established stretch marks. The study was conducted versus two untreated control groups (50 primipara untreated and 50 multipara with stretch marks).

Results:
"Prevention of stretch marks in pregnancy: 89% positive results. Established stretch marks: 41% positive results in reduction of stretch marks." It should be noted that this study was published in a military medical journal "The Turkish Navy Medical Bulletin."

Investigators:
Dr.C.RIGONI, Dr.G.SCARABELLI, Dr.G.SPINELLI, Dr.P.TOFFOLO
Univerista degli Studi de Milano, Italy
Instituto di Clinical Dermatologica I et Dermatologica Pediatrica, IRCCS - Ospedale Maggiore de Milano

Method:
"51 women, 11 to 47 years of age (mean 25.6 years), with stretch marks were enrolled. The study protocol for enrollment included an objective examination and recording of a skin impression at the start and at the end of the treatment (40 days) with the aim of evaluating the site, dimensions, color and number of striae." (page 1)

Results:
"…Based on this clinical study, we confirm that the product we have tested did not in any case demonstrate total disappearance of stretch marks. But, in our study group we observed a slight improvement in 55.5% of cases and a more marked improvement in 24.4% of cases, i.e. improvement in 24.4% of cases, i.e. improvement in 80% of cases observed." It should be noted that this study was published in the official organ of the Italian Society of Dermatology and Venereology "Italian Journal of Dermatology and Venereology", Vo.128, 1993.

Investigators:
Dr.C.LESCA-BACH, Study Center : EVIC CEBA, BORDEAUX.
P.MASSON, Medical laboratory specialist, Toxicology-Pharmacology Expert, Director of Study Laboratory.

Method:
A single-center trial comparing Phytolastil versus the référence product on the market whose effectiveness is widely renown, and with statistical analysis (randomization). This trial was conducted in compliance with the Declaration of Helsinki (1965), with revisions in Tokyo (1967), Venice (1983), Hong Kong (1988) and was submitted to an Ethics Committee. The study involved a panel of 43 persons who formed a homogeneous group (sex, age, weight, and stretch marks). Efficacy of Phytolastil was assessed based on subjective criteria (visual examination) or objective criteria (measurement, analysis of skin impression, chromametric measurements) for 13 weeks.

Results:
"… Based on these results, we thus can conclude that Phytolastil solution was as effective as the référence product and consequently promotes the reduction of abdominal stretch marks resulting from pregnancy."

Investigators:
Dr.P.VIGE, Hôpital St.Cloud
Dr.M.MEZARD-EURIN, Gecem, Paris, France.

Method:
Single-blind, multicenter, parallel-group trial comparing Phytolastil versus a reference product on the market whose effectiveness is widely known, and with statistical analysis (randomization). This study involved a panel of 90 women: 53 in the Phytolastil group and 46 in the comparative group. The study protocol was approved by an Ethics Committee in application of the Huriet law in France on cosmetic products.

Results:
"… In this trial on 99 patients, 53 treated with Phytolastil and 46 treated with référence product, from month 3 of pregnancy up to 1 month post-partum, no statistical difference was demonstrated. However, stretch marks developed in the 16% of women treated with Phytolastil (i.e. 84% good results) and in 29% in the group treated with reference product (i.e. 71% good results). In 5 women treated with the reference product this involved a stretch mark in dense skin fibers which was not observed in any patient in the Phytolastil group."

1996: "Clinical trial on the effect of Phytolastil ampuls in the treatment of stretch marks post- partum."

Investigators:
Dr.PASTORFIDE-GB, Dr.MILLA-DC, Dr.SANTOS-ER
Cardinal Santos Memorial San Juan Hospital, Metro, Manila, Philippines.

Method:
Clinical study and photographic measurements on 31 women with stretch marks post-partum treated for 2 months with Phytolastil ampuls.

Results:
"…Significant improvement in color and width of the stretch marks starting on Day 20 of product use with the optimum result on Day 60."

If you have any questions or would like to share your experience
with this product, contact us