STRIAE CREAM WITH REGENETROL COMPLEX™ DEMONSTRATES EFFICACY ON STRETCH MARKS: A DOUBLE BLIND CONTROLLED STUDY
Lawrence S. Moy, M.D.
Timothy Lesser, B.S.
ABSTRACT: This article reviews the efficacy of the first product that is specifically devoted to treating stretch marks. Stretch marks previously have been considered an untreatable cosmetic problem. Striae Cream with the Regenetrol ComplexTM was studied in a double blind controlled format in which the cream applied to one side of the body was compared with the control cream applied to the other side of the body after two months. The results demonstrate that 80% of the patients tested benefited from using the cream and 35% had marked clearing. Results could be seen within 4 weeks. The cream was successful for treating the ridging, redness, and whiteness associated with the stretch marks. Additionally, older and thicker stretch marks demonstrated improvement with Regenetrol ComplexTM application.
INTRODUCTION: Stretch marks, or striae, are a common problem that affects many men and women. Clinically, stretch marks are characterized by a thinning of the skin in streaks usually located around the hips, thighs, buttocks, abdomen, and shoulders. These streaks are often erythematous, hypo pigmented or hyper pigmented, and ridged. Lesions occur commonly in the presence of skin “stretching” and elevated hormone levels. The most classic causes or associations are during:
- Third trimester pregnancy
- Rapid pubertal growth spurts
- Active weight training
- Excessive use of topical cortisones
Histopathologically, there is a marked thinning of all the skin layers and especially dramatic thinning of collagen fibers and other connective tissue. On electron microscopy, there is a breakdown and friable deterioration of the fibers in the region of the stretch marks. Also, fibroblasts have the decreased amounts of endoplasmic reticulum and mitochondria characteristic of relatively low levels of protein synthetic activity. Several articles discuss the use of different products, including retinoid, for the treatment of stretch marks, but a clearly effective treatment has not been found1 The purpose of the study reviewed by this article is to investigate the efficacy of using Striae Cream with the Regenetrol ComplexTM for the treatment of stretch marks.
METHODS & MATERIALS: Healthy normal volunteers were recruited in several dermatologic clinic centers for the studies. Forty patients were gathered who had significant stretch marks on the hips, abdomen, and thighs. The patients had an average age of 37 years with a range of 16 to 47 years of age. Of the 40 patients, 29 had a positive history of stretch marks occurring during or immediately after pregnancy, seven had lesions from puberty growth periods and four had lesions from weight training. Patients were instructed to apply the Striae to the stretch marks twice per day.
Application was done by taking a generous amount and rubbing thoroughly into the skin. A control cream was applied to one side of the body and the Striae Cream with the Regenetrol ComplexTM was applied to the other side.
Both the evaluators and the patients were blinded as to which cream was the Striae Cream with the Regenetrol ComplexTM and which was the placebo. The study lasted for two months, with evaluations at the beginning, after one month, and at the end of the study after two months. The evaluations were separated into different categories. First, the stretch marks were evaluated for specific characteristics, including erythema, hypopigmentation, hyperpigmentation, and ridging. The patients were also evaluated for extent of improvement over the one-month and two-month time period. The evaluation was rated by 0–no change, 1–mild change, 2–moderate change, and 3–marked change. As a separate portion of the study, a blinded evaluator examined the skin and was asked to choose the side that had improved based on the initial evaluations. The evaluator’s chosen side was then compared to the actual treatment side versus the control side.
RESULTS: The study evaluated the consequences of applying Striae Cream with the Regenetrol ComplexTM to the stretch marks on each patient.
Table 1 shows a majority of the patients (80%) had some measurable improvement in the appearance of their stretch marks. Out of the 40 patients studied over the two-month period, 45% had mild improvement, 25% had moderate improvement, and 10% had marked improvement.
Table 2 demonstrates the improvement in specific characteristics of the stretch marks. Erythema and hypopigmentation improved the most dramatically with a 72% response, hyperpigmentation improved in 56% of the cases, and ridging improved in 44% of the cases.
Table 3 shows that the blinded evaluator was able to choose the correct, active cream in 19 out of 20 cases (95%).
CONCLUSION: The study demonstrates the efficacy of a new product for treating stretch marks. 80% of the patients showed an improvement in the appearance of their stretch marks from use of the cream. Although many of the patients had mild to moderate effects, the results were promising because of the short duration of treatment (two months). Anecdotally, a number of patients had measurable improvement in two to four weeks and, in addition, many of the patients showed progressive, dramatic improvement with additional weeks of treatment. The improvement of all the stretch mark characteristics from Table II is very promising for RegenetrolTM. This points to a specific action on stretch marks that can improve all facets of the lesions. In a very short two-month study, the lesions would be expected to improve most dramatically with respect to their erythema and hypopigmentation. The ridging effect would correlate with the deepest histologic effect and would continue to improve with continued therapy, but in two months would not be expected to be the most notable response. The blinded evaluator response was performed to ensure the quality of the products and to ensure that the control cream was not producing similar results as the active cream. Clearly, there is a visual difference that can be seen due to the clinical improvement that RegenetrolTM has on the skin.
Previous studies have initially shown promise with using topical retinoid for stretch marks. However, a recent study demonstrated that retinoic 0.025% cream was “ineffective in improving striae distensae in these subjects.”2 Another study pointed out that the effective tretinoin results seen in some studies were flawed because of a possible irritant effect.3 Other products have been reported in small studies to improve stretch marks. Centella asiatica may be effective, but it is a weak sensitizer; it may also be working based on an irritant effect. RegenetrolTM appears to elevate the level of total protein synthesis. Preliminary laboratory studies have so far shown the elevated total protein synthesis to be correlated with an increase in collagen and elastin. As we demonstrated, the histologic thickness of the epidermis and the dermis was markedly increased as well.4 The increase in total protein levels may explain the advantage RegenetrolTM has over other products tested at this time. As seen from a number of studies, all protein fibers, including keratin, collagen and elastin, were markedly decreased in people with striae distentae.5 Therefore, RegenetrolTM may give the most positive structural support for reversing the weakening of protein fibers associated with stretch marks. Although the study did not specifically examine the most responsive patient for RegenetrolTM treatment, anecdotal experience has shown that stretch marks that are both older and newer can respond well; however, the early stretchmark lesions appear to be more responsive. Additionally, stretch marks from pregnancy and weight training appear to respond equally to the product. Responses to growth spurts were positive but efficacy was a little less. Anatomical areas did not appear to affect the effectiveness of the product. RegenetrolTM has an important mechanism of action which may apply to other conditions characterized by atrophy and thinning of skin layers. Further studies are being conducted to investigate other functional uses of RegenetrolTM, including wrinkles, solar purpura, and photodamage. Because RegenetrolTM is a newly discovered ingredient, we are also expanding studies that examine its benefit for treating stretch marks.
In conclusion, RegenetrolTM is the first product ever studied that definitely has improved the stretch marks in a short, double-blinded clinical study with specific improvement in the basic clinical characteristics of the stretch marks.
with Regenetrol Complex®