Clinical Results

Stratamark is the only topical product for the prevention and treatment of Striae with proven clinical evidence1

The first Stratamark publication1 demonstrating the efficacy evidence for both prevention and treatment of stretch marks.

A volunteer sample of 303 women, presenting to 61 different Obstetricians in Czech Republic (Europe) for obstetric care participated in the study.

Subjects were divided into two arms:

Prevention: 148 pregnant women with no existing Striae Distensae.

Treatment: 155 women with existing Striae Distensae (both Striae Alba and Striae Rubra) prior to their study participation.

Within the treatment arm some women started their treatment during their current pregnancy as they had pre-existing Srtriae Distensae and some patients started their treatment as late as post-delivery. Many of the women recruited into the treatment arm did not have existing Striae Distensae, had declined participation in the prevention group, and as they developed Striae Distensae during their pregnancy and/or post-delivery, requested to become part of the treatment arm.

All women were instructed not to use other creams or lotions during the study period. All women were asked to apply the gel once per day, and it was explained that the best results were expected if the product was in contact with the skin 24 hours a day 7 days a week (24/7).

Those that used the gel less than 6 days per week were excluded from the study.

 

Study Results – Prevention Arm

  • The average gestational age of the fist Stratamark application was during week 21 of pregnancy (std = 6.44 weeks).
  • Of the 148 women who participated in the prevention arm 18.2 % of these patients developed Striae as assessed by their obstetrician post-delivery in contrast with published 61 % prevalence (p<0.001).
  • A value of 61 % was chosen as the background prevalence for the development of Striae as demonstrated by Osman et al.2
  • 83.8 % of questioned participants consider the gel would help to prevent Striae.
  • The prevention of Striae development with Stratamark use was neither influenced by the gestational age at starting of application (p = 0.77) nor by the gestational age at delivery (p = 0.94), nor the delivery method (p = 0.76), nor the location of the investigation (p = 0.5).
  • Only 1 case with moderate–severe and no severe or very severe cases were observed.

 

*Data from: Osman H et al. BJOG 2008;115:1138–1142
The reported prevalence of Striae ranges between 50–90 %, with most control groups showing between 60 % and 70 % developed during pregnancy, depending on the population studied.2,3

 

Study Results – Treatment Arm

  • 155 women who participated in the treatment arm had Striae prior to this study.
  • From the 96 cases of Striae under 2 weeks of age, 81 cases happened during pregnancy and 15 post-delivery. The rest of the studied population (74 subjects) applied Stratamark for the first time post-delivery.
  • Average severity of Striae prior to beginning treatment with application of Stratamark scored 3.50 (from 1 to 7) and ended at 1.84 (std respectively 1.62 and 1.10). This improvement was found to be significant (p-value <0.001).

 

 

  • colour assessment of Striae in comparison to surrounding healthy skin pre and post treatment demonstrated that 1.97 % (3/152) had a disappearance of Striae colour.
  • For visibility pre and post treatment comparison as assessed by the patient’s obstetrician post-delivery 3.36 % (5/149) showed a disappearance of Striae.
  • Pruritus in pregnancy can be severe and psychologically distressing and is commonly not addressed adequately by current therapy options. In the study – the pruritus rating – 19.21 % (29/152) reported the disappearance of pruritus.
  • In the study doctors used a compliance of 6 or more days per week and an end point of 60 days post-delivery, but many women reported still seeing improvements in their Striae at our study end point.

 

1. Malkova S. The effect of innovative gel in the prevention and treatment of Striae Distensae (Stratamark gel). New EU Magazine of Medicine, July 2014, 1–4/2014.
2. Osman H et al. BJOG 2008; 115:1138–1142
3. Elsaie ML et al. Dermatologic Surgery 2009; 35:563–573