Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy

NCT07521462 | Not Yet Recruiting

• 2 other identifiers: RB_2025-012025-A00892-47
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this clinical study is to evaluate the effectiveness and safety of a dermocosmetic product in reducing facial redness and visible blood vessels associated with erythematotelangiectatic rosacea. Investigators will compare the dermocosmetic product to a placebo applied to opposite sides of the face, when used alone and in combination with laser treatment. Participants will apply the products twice daily for 2 month followed by continued use in combination with laser treatment, and will attend regular clinical visits for assessments and questionnaires.

Conditions

Rosacea, Erythematotelangiectatic; Rosacea Subtype 1 (Erythematotelangiectatic)

Keywords

Erythematotelangiectatic Rosacea; Telangiectasia; Dermocosmetic; Laser Therapy

Outcome Measures

Primary Outcomes (1)

• Efficacy of the dermocosmetic product

  To evaluate the efficacy of the dermocosmetic product when used as a monotherapy and following laser treatment on visible microvessels and facial redness associated with rosacea.

  From enrollment to the end of treatment at 8 months

Secondary Outcomes (1)

• Tolerance

  From enrollment to the end of treatment at 8 months

Study Arms (2)

Split-Face dermocosmetic

EXPERIMENTAL

Participants receive both treatments in a split-face design, with the dermocosmetic product applied to one side of the face and placebo applied to the opposite side. Treatments are applied twice daily.

Other: Dermocosmetic tested product; Device: Vascular laser treatment

Split-Face placebo

PLACEBO COMPARATOR

Participants receive both treatments in a split-face design, with the dermocosmetic product applied to one side of the face and placebo applied to the opposite side. Treatments are applied twice daily.

Other: Placebo; Device: Vascular laser treatment

Interventions

Dermocosmetic tested product OTHER

The dermocosmetic product will be applied topically to one side of the face twice daily.

Split-Face dermocosmetic

Placebo OTHER

The placebo is a dermocosmetic formulation identical in appearance, texture, and application to the active product but without active ingredients. It is applied topically to the opposite side of the face twice daily, following the same regimen as the active product.

Split-Face placebo

Vascular laser treatment DEVICE

Participants receive three sessions of vascular laser treatment performed at regular intervals during the study. Laser therapy is used as part of standard care to target facial redness and visible blood vessels. The dermocosmetic product and placebo continue to be applied as adjunct treatments during this phase.

Split-Face dermocosmetic; Split-Face placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gender: male or female
• Age: \> 18 years -Patients with mild to severe erythro-couperotic rosacea (stage 2, 3, or 4 - TRoSA scale, section 2.2.3.1)
• Patients wishing to undergo vascular laser treatments for their rosacea
• Patients who have provided informed consent

You may not qualify if:

• Pregnant patients or patients with a positive urine pregnancy test at the initial visit
• Patients with another condition in the study area.
• Patients who have received laser treatment for the same condition within the previous 12 months.
• Patients with another form of rosacea (e.g., papules and pustules, ocular rosacea, etc.).
• Patients using another anti-redness product on the face during the study.
• Patients who have taken photosensitizing treatments during the month prior to study enrollment.
• Patients taking or having taken oral isotretinoin within 6 months prior to study enrollment.
• Patients enrolled in another study.
• Adult patients under a legal guardianship arrangement (guardianship, conservatorship, judicial protection).
• Patients not covered by social security.

Sponsors & Collaborators

• ISISPHARMA: lead

Related Publications (6)

• Schaller M, Almeida LMC, Bewley A, Cribier B, Del Rosso J, Dlova NC, Gallo RL, Granstein RD, Kautz G, Mannis MJ, Micali G, Oon HH, Rajagopalan M, Steinhoff M, Tanghetti E, Thiboutot D, Troielli P, Webster G, Zierhut M, van Zuuren EJ, Tan J. Recommendations for rosacea diagnosis, classification and management: update from the global ROSacea COnsensus 2019 panel. Br J Dermatol. 2020 May;182(5):1269-1276. doi: 10.1111/bjd.18420. Epub 2019 Oct 16.

  PMID: 31392722 BACKGROUND

• Chajra H, Nadim M, Auriol D, Schweikert K, Lefevre F. Combination of new multifunctional molecules for erythematotelangiectatic rosacea disorder. Clin Cosmet Investig Dermatol. 2015 Oct 1;8:501-10. doi: 10.2147/CCID.S92326. eCollection 2015.

  PMID: 26491365 BACKGROUND

• Kowalska A, Kalinowska-Lis U. 18beta-Glycyrrhetinic acid: its core biological properties and dermatological applications. Int J Cosmet Sci. 2019 Aug;41(4):325-331. doi: 10.1111/ics.12548. Epub 2019 Jun 28.

  PMID: 31166601 BACKGROUND

• Cribier B. Rosacea: Treatment targets based on new physiopathology data. Ann Dermatol Venereol. 2022 Jun;149(2):99-107. doi: 10.1016/j.annder.2021.11.001. Epub 2021 Dec 8.

  PMID: 34893359 BACKGROUND

• Schaller M, Almeida LM, Bewley A, Cribier B, Dlova NC, Kautz G, Mannis M, Oon HH, Rajagopalan M, Steinhoff M, Thiboutot D, Troielli P, Webster G, Wu Y, van Zuuren E, Tan J. Rosacea treatment update: recommendations from the global ROSacea COnsensus (ROSCO) panel. Br J Dermatol. 2017 Feb;176(2):465-471. doi: 10.1111/bjd.15173. Epub 2017 Feb 5.

  PMID: 27861741 BACKGROUND

• Tan J, Almeida LM, Bewley A, Cribier B, Dlova NC, Gallo R, Kautz G, Mannis M, Oon HH, Rajagopalan M, Steinhoff M, Thiboutot D, Troielli P, Webster G, Wu Y, van Zuuren EJ, Schaller M. Updating the diagnosis, classification and assessment of rosacea: recommendations from the global ROSacea COnsensus (ROSCO) panel. Br J Dermatol. 2017 Feb;176(2):431-438. doi: 10.1111/bjd.15122. Epub 2017 Jan 23.

  PMID: 27718519 BACKGROUND

MeSH Terms

Conditions

Rosacea; Telangiectasis

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Olivia BAUVIN, Doctor of Medicine

  Department of Dermatology and Venereology, Charles-Nicolle Hospital, Rouen, FRANCE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloe GOYET, Master degree

CONTACT

+33 627806219; cgoyet@isispharma.com

Amelie CLEMENT, Engineering degree

CONTACT

+33 6 29 76 53 54; aclement@isispharma.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Split-Face dermocosmetic and placebo Participants apply dermocosmetic to one side of the face and placebo to the opposite side according to a randomized, double-blind split-face design.

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share