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Cream With Cutaneous Fibroblast Lysate for the Treatment of Provoked Vestibulodynia: A Double-Blind Randomized Placebo-Controlled Crossover Study

Donders, Gilbert G. MD, PhD1,2,3; Bellen, Gert RN3

Journal of Lower Genital Tract Disease: October 2012 - Volume 16 - Issue 4 - p 427–436
doi: 10.1097/LGT.0b013e31825a2274
Original Articles

Objective: Is treatment of provoked localized vulvodynia with cutaneous lysate skin cream containing human cytokines effective?

Methods: This is a double-blind placebo-controlled randomized crossover trial with a study and a placebo cream applied twice daily for 3 months, 1-week washout, followed by a 3-month crossover medication in 30 patients experiencing provoked localized vulvodynia with visible vulvar erythema. Tolerability of the product, sexual functioning, and clinical findings were the main outcomes. A linear model for repeated measures was used for all visits. Effect after 4 weeks of treatment, effect after 12 weeks of treatment, and, finally, carryover effects of first and second order were estimated. A Wilcoxon signed rank test was used to evaluate 4- and 12-week changes within a group, and Mann-Whitney U test was used to evaluate 4- and 12-week changes between groups.

Results: Tolerability of the cream was excellent and not different from that of placebo. During the first 12 weeks, use of the active cream resulted in a significant reduction in pain during sexual activity after 4 and 12 weeks (p < .05); however, use of the placebo cream did not. When analyzing the entire pain data with the statistical model for crossover clinical study design, the active cream resulted in a decrease of 1.1 points (95% confidence interval = −0.6 to 2.8, p = .20) and 1.3 points (95% confidence interval = 0.1 to 2.5, p = .037) in the visual analog scale score compared with that of placebo after 4 and 12 weeks of treatment, respectively. There was evidence for a second-order carryover effect (p = .024). The pain reduction was most evident for women with secondary dyspareunia. Erythema was reduced after use of the cream at 4 (p = .03) and 12 (p = .01) weeks but not after placebo.

Conclusions: As opposed to placebo, use of cutaneous lysate cream was more effective in reducing focal redness and pain while having intercourse in patients with provoked localized vulvodynia with erythema.

Women with provoked vulvodynia (vulvar vesitibulitis syndrome) had less pain and redness while using a biorestorative cutaneous lysate cream compared to placebo.

1Department of Obstetrics and Gynecology, Regional Hospital Heilig Hart, Tienen; 2University Hospital Gasthuisberg, Leuven; and 3Femicare VZW, Tienen, Belgium

Reprint requests to: Gilbert G. Donders, MD, PhD, Femicare Clinical Research for Women, Gasthuismolenstraat 31, 3300 Tienen, Belgium. E-mail: gilbert.donders@femicare.net

This study was initiated and performed by the investigators only. None of the authors have a conflict of interest directly linked within the content of the article.

©2012The American Society for Colposcopy and Cervical Pathology