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RosaceaNCT07729540

Efficacy of IPL, an Anti-redness Dermocosmetic, and Their Combination in the Treatment of Rosacea

A study testing Intense Pulsed Light (IPL) - Lumecca and Rosacure anti-redness dermocosmetic regimen in people with Rosacea, run by Medical University of Silesia at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study compares three approaches to treating persistent facial redness in adults with erythematotelangiectatic rosacea: intense pulsed light (IPL) treatment alone, a professional anti-redness dermocosmetic skincare regimen alone, and the combination of both. Read more about this study

Who is it for?
Ages 20 to 57 years
Conditions the study is for
Rosacea
What is being tested?
Intense Pulsed Light (IPL) - Lumecca and Rosacure anti-redness dermocosmetic regimen
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePoland
Study dates
29 Sep 2025to 30 Apr 2026
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 20 to 57 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult patients with a dermatologist-confirmed diagnosis of erythematotelangiectatic rosacea

Who cannot join

  • Age under 18 years
  • Pregnancy or breastfeeding
  • Predisposition to keloid or hypertrophic scarring
  • Use of systemic or topical retinoids, antibiotics, or hormonal therapy within the washout period specified for each agent
  • Chemical peeling within one month
  • Laser treatment or phototherapy within three months
Show all 10Show fewer
  • Photosensitizing medications or herbal preparations
  • Inflammatory dermatoses other than rosacea
  • Autoimmune disease
  • Active skin infection in the treatment area

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Medical University of Silesia

    Sosnowiec, 41-200

Other trials in Poland

About this study

Official title: Intense Pulsed Light, a Targeted Anti-Redness Dermocosmetic Regimen, and Their Combination for Erythematotelangiectatic Rosacea: A Comparative Study Using Antera 3D Chromophore Mapping, Grey-Level Co-Occurrence Matrix Texture Analysis and Clinician Erythema Assessment Scale.

This study compares three approaches to treating persistent facial redness in adults with erythematotelangiectatic rosacea: intense pulsed light (IPL) treatment alone, a professional anti-redness dermocosmetic skincare regimen alone, and the combination of both. The main question the study aims to answer is which of these three strategies is more effective at reducing facial redness, using both clinician grading and objective skin-imaging tools that measure redness and skin texture before and after treatment.

Read the detailed description

This was a prospective, single-center, three-arm comparative study conducted in an outpatient setting, with 60 adult patients with a dermatologist-confirmed diagnosis of erythematotelangiectatic rosacea allocated to one of three parallel treatment groups (20 patients per group). No randomization or blinding was performed.

Group 1 (IPL) received three intense pulsed light treatments with the Lumecca applicator (InMode; 515-1200 nm) at 21-day intervals, with fluence individually titrated to skin response; broad-spectrum SPF 50+ sunscreen was applied after each session, and daily photoprotection was mandatory.

Group 2 (dermocosmetic) received four professional in-office anti-redness treatments using the Rosacure Professional system (Synchroline/Cantabria Labs) at 7-day intervals - gentle cleansing, application of Rosacure Professional Serum Booster, and a leave-on regenerating gel mask - together with a standardized 12-week home-care regimen (twice-daily gentle cleanser, Rosacure Intensive SPF 30 in the morning, Rosacure Fast in the evening, and a leave-on mask twice weekly).

Group 3 (combination) received the same three IPL treatments as Group 1, immediately followed within the same session by the professional Rosacure protocol, at 21-day intervals, together with the same home-care regimen used in Group 2.

Facial redness was assessed using objective imaging (Antera 3D chromophore mapping and Gray-Level Co-occurrence Matrix texture analysis) and by clinician grading, at baseline, 2 weeks after the treatment series, and 8 weeks after the treatment series.

Conditions
Rosacea
Being tested
Intense Pulsed Light (IPL) - Lumecca, Rosacure anti-redness dermocosmetic regimen
Keywords
Erythema, Intense Pulsed Light, Dermocosmetic, Antera 3D Chromophore Mapping, Gray-Level Co-Occurrence Matrix Texture Analysis, Clinician Erythema Assessment, Lumecca, Rosacure
Medical subject headings
Rosacea, Erythema

What participants receive

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

  • Intense Pulsed Light (IPL) - LumeccaDevice

    IPL treatment (515-1200 nm) delivered with the Lumecca applicator (InMode, Irvine, CA, USA), administered as three sessions at 21-day intervals with fluence individually titrated to skin response.

  • Rosacure anti-redness dermocosmetic regimenOther

    Professional in-office anti-redness regimen (Rosacure Professional system: gentle cleansing, Rosacure Professional Serum Booster, leave-on regenerating gel mask) plus a standardized 12-week home-care regimen (Rosacure Intensive SPF 30 mornings, Rosacure Fast evenings, leave-on mask twice weekly), manufactured by Synchroline/Cantabria Labs, Spain.

Study groups in NCT07729540
Study groupRoleWhat they receive
IPL Monotherapy (Lumecca)ExperimentalThree intense pulsed light (IPL) treatments using the Lumecca applicator (InMode; 515-1200 nm) at 21-day intervals. Fluence was individually titrated to skin response and increased across sessions. Broad-spectrum sunscreen SPF 50+ was applied after each session, and daily photoprotection was mandatory.
Receives: Device: Intense Pulsed Light (IPL) - Lumecca
Dermocosmetic Regimen (Rosacure Professional)ExperimentalFour professional in-office anti-redness treatments using the Rosacure Professional system (Synchroline/Cantabria Labs) at 7-day intervals: gentle cleansing, application of Rosacure Professional Serum Booster (4-t-butylcyclohexanol, niacin amide, panthenol, sodium hyaluronate, polyglutamic acid), and a leave-on regenerating gel mask. Concurrently, a standardized 12-week home-care regimen: twice-daily gentle cleanser, Rosacure Intensive SPF 30 each morning, Rosacure Fast each evening, and a leave-on mask twice weekly.
Receives: Other: Rosacure anti-redness dermocosmetic regimen
Combined IPL and Dermocosmetic TherapyExperimentalThree IPL treatments identical to Arm 1 (Lumecca applicator, 515-1200 nm, 21-day intervals), immediately followed within the same session by the professional Rosacure protocol described in Arm 2, together with the same 12-week home-care regimen used in Arm 2.
Receives: Device: Intense Pulsed Light (IPL) - Lumecca; Other: Rosacure anti-redness dermocosmetic regimen

What is being measured

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

  1. Antera 3D Erythema Index (Mean, Minimum, and Maximum)

    Erythema quantified via the Antera 3D camera (Miravex, Dublin, Ireland), which reconstructs hemoglobin distribution from multidirectional, multispectral light reflectance and expresses erythema on a reproducible relative scale. For each patient and time point, three erythema indices - mean, minimum, and maximum - were extracted for the left and right cheek and averaged into a single value per index.

    Measured: Baseline, 2 weeks after the treatment series, and 8 weeks after the treatment series

Secondary outcomes (3)

  1. GLCM Contrast

    Gray-Level Co-occurrence Matrix (GLCM) texture parameter quantifying local brightness variation of the erythematous facial skin from cross-polarized photographs (8-bit grayscale, 256×256 co-occurrence matrix, horizontal offset θ=0°, distance d=1); higher values indicate a more irregular, mottled erythema. Left and right cheek values averaged per patient.

    Measured: Baseline, 2 weeks after the treatment series, and 8 weeks after the treatment series

  2. GLCM Homogeneity

    Gray-Level Co-occurrence Matrix (GLCM) texture parameter quantifying surface uniformity of the erythematous facial skin; higher values indicate more uniform erythema. Derived from the same cross-polarized photographs and co-occurrence matrix as GLCM contrast. Left and right cheek values averaged per patient.

    Measured: Baseline, 2 weeks after the treatment series, and 8 weeks after the treatment series

  3. Clinician Erythema Assessment (CEA) Score

    Semi-quantitative 5-point ordinal scale (0-4) graded by trained dermatologists, where 0 = no visible erythema and 4 = severe, intense redness; mean of scores from three independent raters.

    Measured: Baseline, 2 weeks after the treatment series, and 8 weeks after the treatment series

Timeline

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

  1. First posted27 Jul 2026
  2. Study start29 Sep 2025
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2026

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
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07729540
Sponsor's protocol ID
KNW/0022/KB//II/16/17
Status last verified
Jul 2026
First submitted
22 Jul 2026
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data underlying the results of this study may be reported across one or more publications arising from this dataset. Data will be made available to qualified researchers upon reasonable request to the corresponding author.

Publications

  • Ou X, Pan W, Xiao P. In vivo skin capacitive imaging analysis by using grey level co-occurrence matrix (GLCM). Int J Pharm. 2014 Jan 2;460(1-2):28-32. doi: 10.1016/j.ijpharm.2013.10.024. Epub 2013 Nov 2.

    PubMed 24188984

  • Crea F, Pupita G, Galassi AR, el Tamimi H, Kaski JC, Davies GJ, Maseri A. Effect of theophylline on exercise-induced myocardial ischaemia. Lancet. 1989 Apr 1;1(8640):683-6. doi: 10.1016/s0140-6736(89)92204-6.

    PubMed 2564505

  • Seo JK, Shin EJ, Jeong KH, Shin MK. Clinician Severity Assessment Grading Scale on Erythematotelangiectatic Rosacea. Indian J Dermatol. 2021 Mar-Apr;66(2):203-205. doi: 10.4103/ijd.IJD_611_19. No abstract available.

    PubMed 34188282

  • Tan J, Liu H, Leyden JJ, Leoni MJ. Reliability of Clinician Erythema Assessment grading scale. J Am Acad Dermatol. 2014 Oct;71(4):760-3. doi: 10.1016/j.jaad.2014.05.044. Epub 2014 Jul 4.

    PubMed 24999270

  • Piccolo D, Fusco I, Zingoni T, Conforti C. Effective Treatment of Rosacea and Other Vascular Lesions Using Intense Pulsed Light System Emitting Vascular Chromophore-Specific Wavelengths: A Clinical and Dermoscopical Analysis. J Clin Med. 2024 Mar 13;13(6):1646. doi: 10.3390/jcm13061646.

    PubMed 38541871

  • Zhai Q, Cheng S, Liu R, Xie J, Han X, Yu Z. Meta-Analysis of the Efficacy of Intense Pulsed Light and Pulsed-Dye Laser Therapy in the Management of Rosacea. J Cosmet Dermatol. 2024 Dec;23(12):3821-3827. doi: 10.1111/jocd.16549. Epub 2024 Sep 6.

    PubMed 39240125

  • Sulk M, Seeliger S, Aubert J, Schwab VD, Cevikbas F, Rivier M, Nowak P, Voegel JJ, Buddenkotte J, Steinhoff M. Distribution and expression of non-neuronal transient receptor potential (TRPV) ion channels in rosacea. J Invest Dermatol. 2012 Apr;132(4):1253-62. doi: 10.1038/jid.2011.424. Epub 2011 Dec 22.

    PubMed 22189789

Questions about this trial

What is this clinical trial studying?

A study testing Intense Pulsed Light (IPL) - Lumecca and Rosacure anti-redness dermocosmetic regimen in people with Rosacea, run by Medical University of Silesia at 1 site in Poland.

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 1 inclusion and 10 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: finished, as of the sponsor's last update on 27 Jul 2026. 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 Poland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antera 3D Erythema Index (Mean, Minimum, and Maximum) (time frame: Baseline, 2 weeks after the treatment series, and 8 weeks after the treatment series). 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 NCT07729540, which also lists 7 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 27 Jul 2026.

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