RFMN in Combination With 1927 nm Thulium Laser for Treating Photoaged Skin

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-15

Study Completion Date

2025-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The appearance of the aging skin is influenced by different factors including by the reduced elasticity and increased laxity of the skin, the decreasing volume as well as pigmentation disorders and dilated vascular markings. Currently, there are different methods available to treat the aging skin. Here, the combined treatment of radiofrequency micro needling (RFMN) and thulium laser has been commonly used in clinical practice.

The aim of this clinical study is to investigate the efficacy, patient satisfaction, safety of RFMN and thulium laser treatment in patients with facial, age-related skin laxity, wrinkles, and pigmented lesions.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study on the Effectiveness and Safety Evaluation of Combination Therapy With 1,927nm Thulium Laser and Fractional Microneedle Radiofrequency Equipment for Improvement of Skin Aging

NCT03739398

Wrinkle

COMPLETED NA

Safety & Efficacy Evaluation of a Radiofrequency & Laser/Light System for Improvement of Skin Texture

NCT01597323

Skin Texture Irregularities Facial Skin Wrinkles

COMPLETED

Hyaluronic Acid Delivery: CO2 Laser Versus Thulium Laser Treatment

NCT06431282

Aging Skin

RECRUITING NA

Fractional Radiofrequency for Treatment of Acne Scars and Wrinkles

NCT05827510

Acne Wrinkle

COMPLETED NA

TriActive+ Radiofrequency (RF) for Non-invasive Treatment of Wrinkles & Rhytides

NCT01460927

Wrinkles Rhytides

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Photoaging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RFMN+Thulium

Group Type ACTIVE_COMPARATOR

radiofrequency microneedling combined with 1927 nm thulium laser

Intervention Type DEVICE

1. session: radiofrequency microneedling + 1927 nm thulium laser
2. session: 1927 nm thulium laser monotherapy
3. session: 1927 nm thulium laser monotherapy

RFMN

Group Type ACTIVE_COMPARATOR

radiofrequency microneedling monotherapy

Intervention Type DEVICE

1 session: radiofrequency microneedling monotherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

radiofrequency microneedling combined with 1927 nm thulium laser

1. session: radiofrequency microneedling + 1927 nm thulium laser
2. session: 1927 nm thulium laser monotherapy
3. session: 1927 nm thulium laser monotherapy

Intervention Type DEVICE

radiofrequency microneedling monotherapy

1 session: radiofrequency microneedling monotherapy

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Men and women from the age of 30 years
* good general condition, no relevant previous diseases
* Presence of wrinkles, dermatochalasis on the face, pigment spots, which are an indication for RFMN and thulium laser or comparable methods
* Cognitive ability and willingness to give consent (informed consent)
* Be willing and able to attend follow-up visits

Exclusion Criteria

* Age \< 30 years
* Pregnancy or breastfeeding
* Excessive subcutaneous fatty tissue under the cheeks
* Significant scarring of the region to be treated
* open wounds or lesions of the region to be treated
* Severe or cystic facial acne
* Metallic implants in the face or neck region
* Mental illnesses (psychoses, body perception disorders)
* Use of isotretinoin or other retinoids, psychotropic drugs, coumarins or heparins in the last 2 weeks
* Fillers in the region to be treated \< 4 weeks prior and during the study period
* Resurfacing (fractional, ablative, nonablative) of the region of interest \< 2 months prior and during the study period
* Plastic aesthetic procedures or other surgical procedures \< 6 months prior and during the study period
* Tendency to have excessive scarring
* Lack of informed consent

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes