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Completed

NCT Number: NCT07729540

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

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.

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Key information

Conditions

Rosacea Erythema Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

20 year–57 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Silesia

Sosnowiec, 41-200, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Intense Pulsed Light (IPL) - Lumecca

Device

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 regimen

Other

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.

Primary outcomes

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

    Time frame: Baseline, 2 weeks after the treatment series, and 8 weeks after the treatment series

    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.

Secondary outcomes

  1. GLCM Contrast

    Time frame: Baseline, 2 weeks after the treatment series, and 8 weeks after the treatment series

    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.

  2. GLCM Homogeneity

    Time frame: Baseline, 2 weeks after the treatment series, and 8 weeks after the treatment series

    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.

  3. Clinician Erythema Assessment (CEA) Score

    Time frame: Baseline, 2 weeks after the treatment series, and 8 weeks after the treatment series

    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.

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Collaborators

  • Synchroline/Cantabria Labs

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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