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PhotoagingNCT06029725

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

A study testing radiofrequency microneedling combined with 1927 nm thulium laser and radiofrequency microneedling monotherapy in people with Photoaging, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 years and olderHealthy volunteers can take part
Conditions the study is for
Photoaging
What is being tested?
radiofrequency microneedling combined with 1927 nm thulium laser and radiofrequency microneedling monotherapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteGermany
Study dates
15 Dec 2023to 1 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

L Nguyen contact

+49

l.nguyen@uke.de

Germany1 site, 1 recruiting

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20251

    L Nguyen, +49 (0)40-74100, l.nguyen@uke.de

    Recruiting

Other trials in Germany

About this study

Official title: RFMN in Combination With 1927 nm Thulium Laser for Treating Photoaged Skin: a Prospective, Controlled Study

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.

Conditions
Photoaging
Being tested
radiofrequency microneedling combined with 1927 nm thulium laser, radiofrequency microneedling monotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radiofrequency microneedling combined with 1927 nm thulium laserDevice

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

  • radiofrequency microneedling monotherapyDevice

    1 session: radiofrequency microneedling monotherapy

Study groups in NCT06029725
Study groupRoleWhat they receive
RFMN+ThuliumActive comparatorNot described
Receives: Device: radiofrequency microneedling combined with 1927 nm thulium laser
RFMNActive comparatorNot described
Receives: Device: radiofrequency microneedling monotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in wrinkles

    software-assisted evaluation of wrinkles (Vectra(R) Software, Canfield)

    Measured: 6 months after last treatment session

  2. Change in volume

    software-assisted evaluation of volume (Vectra(R) Software, Canfield)

    Measured: 6 months after last treatment session

  3. Change in pigmentation

    software-assisted evaluation of pigmentation (Vectra(R) Software, Canfield)

    Measured: 6 months after last treatment session

Secondary outcomes (3)

  1. Pain intensity

    pain intensity (numeric rating scale) during treatment

    Measured: 10 minutes after starting each treatment session, one treatment session takes 30-50 minutes

  2. Adverse Events

    number of adverse events (AE)

    Measured: before every treatment session, at every follow-up visit (3 and 6 months post-treatment)

  3. Withdrawals due to AE

    number of withdrawal due to AE

    Measured: before every treatment session, at every follow-up visit (3 and 6 months post-treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2023
  2. Study start15 Dec 2023
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06029725
Sponsor's protocol ID
03-23
Status last verified
May 2024
First submitted
23 Aug 2023
Last updated
21 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Berneburg M, Plettenberg H, Krutmann J. Photoaging of human skin. Photodermatol Photoimmunol Photomed. 2000 Dec;16(6):239-44. doi: 10.1034/j.1600-0781.2000.160601.x.

    PubMed 11132125

  • el-Domyati M, el-Ammawi TS, Medhat W, Moawad O, Brennan D, Mahoney MG, Uitto J. Radiofrequency facial rejuvenation: evidence-based effect. J Am Acad Dermatol. 2011 Mar;64(3):524-35. doi: 10.1016/j.jaad.2010.06.045.

    PubMed 21315951

  • Zelickson BD, Kist D, Bernstein E, Brown DB, Ksenzenko S, Burns J, Kilmer S, Mehregan D, Pope K. Histological and ultrastructural evaluation of the effects of a radiofrequency-based nonablative dermal remodeling device: a pilot study. Arch Dermatol. 2004 Feb;140(2):204-9. doi: 10.1001/archderm.140.2.204.

    PubMed 14967794

  • Nguyen L, Blessmann M, Schneider SW, Herberger K. Radiofrequency Microneedling for Skin Tightening of the Lower Face, Jawline, and Neck Region. Dermatol Surg. 2022 Dec 1;48(12):1299-1305. doi: 10.1097/DSS.0000000000003607. Epub 2022 Sep 29.

    PubMed 36449871

  • Wang JV, Christman MP, Feng H, Ferzli G, Jeon H, Geronemus RG. Laser-assisted delivery of tranexamic acid for melasma: Pilot study using a novel 1927 nm fractional thulium fiber laser. J Cosmet Dermatol. 2021 Jan;20(1):105-109. doi: 10.1111/jocd.13817. Epub 2020 Nov 11.

    PubMed 33174686

  • Lu K, Cai S. Efficacy and safety comparison between 1927 nm thulium laser and 2940 nm Er:YAG laser in the treatment of facial atrophic acne scarring: a prospective, simultaneous spilt-face clinical trial. Lasers Med Sci. 2022 Apr;37(3):2025-2031. doi: 10.1007/s10103-021-03465-0. Epub 2021 Nov 26.

    PubMed 34826022

  • Serra M, Bohnert K, Sadick N. A randomized, single-blind, study evaluating a 755-nm picosecond pulsed Alexandrite laser vs. a non-ablative 1927-nm fractionated thulium laser for the treatment of facial photopigmentation and aging. J Cosmet Laser Ther. 2018 Oct;20(6):335-340. doi: 10.1080/14764172.2018.1493513. Epub 2018 Jul 18.

    PubMed 30019970

  • Friedman PM, Dover JS, Chapas A, Rahman Z, Ross EV, Kilmer SL, Roberts WE, Sodha P, Stimmel JB, Moncrief MBC, Waibel JS. 1,550 nm Erbium-Doped and 1,927 nm Thulium Nonablative Fractional Laser System: Best Practices and Treatment Setting Recommendations. Dermatol Surg. 2022 Feb 1;48(2):195-200. doi: 10.1097/DSS.0000000000003321.

    PubMed 35050945

  • Nguyen L, Blessmann M, Schneider SW, Herberger K. Radiofrequency Microneedling With 1927 nm Thulium Laser Versus Radiofrequency Microneedling Monotherapy for Rejuvenation of Photoaged Skin. J Cosmet Dermatol. 2026 Jan;25(1):e70685. doi: 10.1111/jocd.70685.

    PubMed 41566557

Questions about this trial

What is this clinical trial studying?

A study testing radiofrequency microneedling combined with 1927 nm thulium laser and radiofrequency microneedling monotherapy in people with Photoaging, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact L Nguyen (+49, l.nguyen@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in wrinkles (time frame: 6 months after last treatment session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06029725, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.

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