Efficacy and Safety of CO₂ Laser Therapy Combined With Collagen Cream in Managing Vulvo-Vaginal Atrophy: A Randomized, Controlled Study on Symptom Relief and Microbiome Modulation

Institute for Social Security, Republic of San Marino

Status: Completed

Conditions: Vulva; Atrophy

Treatments: Device: Laser Therapy Only (Control Group); Device: SmartXide2 treatment plus the application of Palingen cream

Study type: Interventional

Funder types: Other

Identifiers

NCT07246616

N/1 (Other Identifier)

MF-01-24 1

Details and patient eligibility

About

This study evaluated a new treatment for postmenopausal women suffering from vulvo-vaginal atrophy (VVA), a condition that causes dryness, burning, and pain. Researchers tested whether combining CO₂ laser therapy with a collagen-based cream could improve symptoms more effectively than laser treatment alone.

Full description

Sixty women participated in the study. Results showed that the combination treatment provided greater relief from discomfort and helped restore vaginal health, with fewer side effects. This approach may offer a safe and effective alternative for women who cannot use hormone-based therapies.

Enrollment: 60 patients

Sex: Female

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women with absence of menstrual cycle for at least 12 months, diagnosed with vulvovaginal atrophy (VVA) and presenting with related symptoms such as dryness, introital and deep dyspareunia, bleeding during intercourse, itching, or burning related to the severity of VVA, whether spontaneous or drug-induced (radio- or chemotherapy), either with a single symptom or a combination thereof.
• Age between 35 and 75 years;
• Patients unresponsive or dissatisfied with previous topical estrogen therapy, or presenting contraindications to the use of local and/or systemic estrogens.
• Previous negative Pap test performed within 3 years prior to study enrollment.

Exclusion criteria

• • Pregnancy or breastfeeding;

  • Presence of preneoplastic or neoplastic lesions of the cervix, vagina, or vulva;
  • Presence of active genital and/or urinary tract infection;
  • Relative or absolute dermatological contraindications to laser use;
  • Ongoing hormonal therapy (systemic or local);
  • Neurological and/or psychiatric disorders;
  • Chronic systemic autoimmune or metabolic diseases;
  • Refusal to provide informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Laser Therapy Only (Control Group)

Active Comparator group

Description:

Participants receive fractional CO₂ laser therapy according to the standard protocol for vulvo-vaginal atrophy. No additional topical treatment is applied. Laser sessions are performed at baseline (Day 0), Day 30, and Day 60. Follow-up visits include clinical evaluation and microbiome sampling at each time point.

Treatment:

Device: Laser Therapy Only (Control Group)

Device: SmartXide2 treatment plus the application of Palingen cream