Product involved: Mucosamin Vaginal Cream

Women treated with Vaginal Brachytherapy after surgery

Study:

Mucosamin® vaginal cream in women treated with VBT (Vaginal Brachytherapy) after surgery in prevention of vaginal mucositis.

Design:

Total: 120 women divided in 2 groups:

  • Group A – treatment with Mucosamin® vaginal (2 applications per day for 1 month);
  • Group B – no treatment.

Measurements:

Evaluation for subjective parameters, included the adverse events as per CTCAE 4.03 scale, at time 0, 3 months and 1 year after treatment.

POST TREATMENT VAGINAL INFLAMMATION (3 MONTHS)

POST TREATMENT VAGINAL PAIN (3 MONTHS)

Light mucositis: grade G0 and G1; Severe Mucositis: grade G2 and G3

Post treatment vaginal dryness (1 year)

Post treatment vaginal structure (1 year)

Light mucositis: grade G0 and G1; Severe Mucositis: grade G2 and G3

Clinical Results

• Application of Mucosamin® vaginal cream during VBT was shown to have clinical benefit for FIGO* stage I endometrial cancer patients who received adjuvant HDR-VBT following surgery.

• It appears to reduce the severity of mucosal reactions.

• Optimal resolution of actinic vaginitis symptoms.

*FIGO – International Federation of Gynecology and Obstetrics

Other Clinical Evidence
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