---
title: "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"
nct_id: NCT07246616
overall_status: COMPLETED
phase: NA
sponsor: Institute for Social Security, Republic of San Marino
study_type: INTERVENTIONAL
primary_condition: Vulva; Atrophy
countries: San Marino
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07246616.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07246616"
ct_last_update_post_date: 2026-01-28
last_seen_at: "2026-05-12T07:27:29.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT07246616](https://clinicaltrials.gov/study/NCT07246616)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Institute for Social Security, Republic of San Marino
- **Conditions:** Vulva; Atrophy
- **Start Date:** 2024-06-01
- **Completion Date:** 2024-10-31
- **CT.gov Last Update:** 2026-01-28

## Brief Summary

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.

## Detailed 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.

## Eligibility

- **Minimum age:** 35 Years
- **Maximum age:** 75 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Laser Therapy Only (Control Group)** (ACTIVE_COMPARATOR) — 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.

## Interventions

- **SmartXide2 treatment plus the application of Palingen cream** (DEVICE) — Patients will be randomized into two groups: one called the "control" group, in which patients will receive only the SmartXide2 treatment, and the second called "PALINGEN," in which patients will receive SmartXide2 treatment plus the application of Palingen cream.
- **Laser Therapy Only (Control Group)** (DEVICE) — 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.

## Primary Outcomes

- **Improvement in VVA (Vulvo-Vaginal Atrophy) symptoms** _(time frame: Outcome: Improvement in symptoms associated with vulvo-vaginal atrophy (VVA) Assessment Tool: Visual Analogue Scale (VAS) Time Frame: Baseline (Day 0) - before treatment Visit 1 (Day 30) - after first month of treatment Visit 2 (Day 60) - after second)_ — Assessed after 30 and 60 days of treatment using the Visual Analogue Scale (VAS).

The VAS was used to quantify symptom intensity such as burning, dryness, itching, dyspareunia, and pain.

Improvement was measured as the difference in VAS scores before and after treatment.

## Secondary Outcomes

- **Vaginal Microbiome Composition** _(time frame: Baseline (Day 0) - before treatment Visit 1 (Day 30) - after first month of treatment Visit 2 (Day 60) - after second month / end of treatment)_
- **Symptom improvement at intermediate time points** _(time frame: Baseline → Visit 1 (Day 30) Baseline → Visit 2 (Day 60))_
- **Adverse Events Monitoring** _(time frame: Continuous from first laser session (Day 0) through 30 days and 60 days post-treatment)_

## Locations (1)

- UOC di Ostetricia e Ginecologia, Ospedale di Stato della Repubblica di San Marino, Istituto per la Sicurezza Sociale (ISS), San Marino, Borgo Maggiore, San Marino

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.uoc di ostetricia e ginecologia, ospedale di stato della repubblica di san marino, istituto per la sicurezza sociale (iss)|san marino|borgo maggiore|san marino` — added _(2026-05-12)_

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*Canonical: https://parkinsonspathways.com/agent/trials/NCT07246616.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07246616*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*