NCT07729540

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2026

Completed
Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 22, 2026

Last Update Submit

July 22, 2026

Conditions

Keywords

ErythemaIntense Pulsed LightDermocosmeticAntera 3D Chromophore MappingGray-Level Co-Occurrence Matrix Texture AnalysisClinician Erythema AssessmentLumeccaRosacure

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

  • GLCM Contrast

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

  • GLCM Homogeneity

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

  • Clinician Erythema Assessment (CEA) Score

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

Study Arms (3)

IPL Monotherapy (Lumecca)

EXPERIMENTAL

Three 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.

Device: Intense Pulsed Light (IPL) - Lumecca

Dermocosmetic Regimen (Rosacure Professional)

EXPERIMENTAL

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 (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.

Other: Rosacure anti-redness dermocosmetic regimen

Combined IPL and Dermocosmetic Therapy

EXPERIMENTAL

Three 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.

Device: Intense Pulsed Light (IPL) - LumeccaOther: Rosacure anti-redness dermocosmetic regimen

Interventions

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.

Combined IPL and Dermocosmetic TherapyIPL Monotherapy (Lumecca)

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.

Combined IPL and Dermocosmetic TherapyDermocosmetic Regimen (Rosacure Professional)

Eligibility Criteria

Age20 Years - 57 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • Photosensitizing medications or herbal preparations
  • Inflammatory dermatoses other than rosacea
  • Autoimmune disease
  • Active skin infection in the treatment area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Silesia

Sosnowiec, 41-200, Poland

Location

Related Publications (7)

  • 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.

    PMID: 24188984BACKGROUND
  • 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.

    PMID: 2564505BACKGROUND
  • 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.

    PMID: 34188282BACKGROUND
  • 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.

    PMID: 24999270BACKGROUND
  • 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.

    PMID: 38541871BACKGROUND
  • 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.

    PMID: 39240125BACKGROUND
  • 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.

    PMID: 22189789BACKGROUND

MeSH Terms

Conditions

RosaceaErythema

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anna Deda, PhD

    Medical University of Silesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2026

First Posted

July 27, 2026

Study Start

September 29, 2025

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

July 27, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
Available upon reasonable request from the corresponding author, beginning from the date of publication, with no specified end date.
Access Criteria
Data will be made available to qualified researchers who submit a reasonable request to the corresponding author (Anna Deda, adeda@sum.edu.pl), for the purpose of methodologically sound reanalysis, subject to authors' approval.

Locations