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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vulva; Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is an interventional, single-center study. 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. It should be noted that both SmartXide2 and Palingen cream (and their combination) have been part of the standard clinical practice at the experimental center for several years.

The effectiveness of the combined action of the two treatments will be evaluated by analyzing the associated symptoms using a Visual Analogue Scale (VAS) from 1 to 10 for each symptom, as well as through analysis of the vaginal microbiome. Additionally, all adverse events will be recorded.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laser Therapy Only (Control Group)

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.

Group Type ACTIVE_COMPARATOR

SmartXide2 treatment plus the application of Palingen cream

Intervention Type 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)

Intervention Type 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.

Interventions

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SmartXide2 treatment plus the application of Palingen cream

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.

Intervention Type DEVICE

Laser Therapy Only (Control Group)

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No