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

NCT07246616 | Completed

• 2 other identifiers: MF-01-24 1N/1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulva; Atrophy

Keywords

Vulva; Atrophy; Co2; Vulvo-vaginal; Microbiome; Modulation; Laser; Theraphy; Collagen; Collagen Cream

Outcome Measures

Primary Outcomes (1)

• Improvement in VVA (Vulvo-Vaginal Atrophy) symptoms

  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.

  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

Secondary Outcomes (3)

• Vaginal Microbiome Composition

  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

  Baseline → Visit 1 (Day 30) Baseline → Visit 2 (Day 60)

• Adverse Events Monitoring

  Continuous from first laser session (Day 0) through 30 days and 60 days post-treatment

Study Arms (1)

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.

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

Interventions

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.

Laser Therapy Only (Control Group)

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)

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute for Social Security, Republic of San Marino: lead

Study Sites (1)

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

San Marino, Borgo Maggiore, 47893, San Marino

Location

Related Publications (1)

• Mueck AO, Ruan X, Prasauskas V, Grob P, Ortmann O. Treatment of vaginal atrophy with estriol and lactobacilli combination: a clinical review. Climacteric. 2018 Apr;21(2):140-147. doi: 10.1080/13697137.2017.1421923. Epub 2018 Jan 30.

  PMID: 29381086 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Atrophy

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dott. Maurizio Filippini

Model Details: 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.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: June 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 31, 2024
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)