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A Clinical Trial Evaluating the Efficacy and Safety of Hyaluronic Acid Compound Filler Combined with Intense Pulsed Light Therapy for Erythematotelangiectatic Rosacea

A Prospective, Randomized, Single-Center, Parallel-Controlled Clinical Trial Evaluating the Efficacy and Safety of Hyaluronic Acid Compound Filler Combined with Intense Pulsed Light Therapy in Erythematotelangiectatic Rosacea.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101323
Enrollment
Unknown
Registered
2025-04-23
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rosacea

Interventions

?Experimental Group:Hyaluronic Acid Compound Filler Combined with Intense Pulsed Light Therapy
Control Group:Intense Pluse Light

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Male or female subjects aged =18 years (inclusive). 2.Fitzpatrick skin phototype II–IV. 3.Clinically confirmed erythematotelangiectatic rosacea (ETR) subtype I per National Rosacea Society Expert Committee (NRSEC) classification, with Clinical Erythema Assessment (CEA) score 2–3. 4.Subjects expressing desire for rosacea improvement. 5.Voluntary provision of signed informed consent and willingness to complete protocol-specified follow-ups.

Exclusion criteria

Exclusion criteria: 1.History of severe diseases in major organs or active autoimmune diseases. 2.Use of rosacea-related medications (oral/topical antibiotics, azelaic acid, vasoconstrictors, etc.) within 1 month prior to screening or planned during the study. 3.Presence of scars, dermatoses (e.g., active infection [herpes simplex], unhealed wounds, progressive dermatoses [vitiligo, psoriasis], or facial inflammatory conditions [seborrheic dermatitis, acne]) in the treatment area that may interfere with efficacy evaluation. 4.Planned or recent interventions affecting study outcomes: a. Procedures within 6 months pre-screening or planned during the study: lasers, light therapies, radiofrequency, dermabrasion, medium/deep chemical peels, degradable fillers (hyaluronic acid, collagen) b. Procedures within 12 months pre-screening or planned during the study: semi-permanent dermal fillers (calcium hydroxylapatite, poly-L-lactic acid) c. Facial treatments pre-screening or planned during the study: silicone implants, fat grafts, thread lifts, permanent fillers (polymethylmethacrylate). 5.History of severe allergies, atopy, planned desensitization therapy, or hypersensitivity to study-related components (hyaluronic acid, L-carnosine, vitamin B2, lidocaine/amide anesthetics). 6.Pregnancy, lactation, planned pregnancy (or males unwilling to use contraception), or positive pregnancy test at screening. 7.History of hypertrophic scars or keloid tendency. 8.Participation in other clinical trials within 30 days pre-screening. 9.Other systemic conditions deemed unsuitable for participation by investigators. 10.Bleeding tendency or current use of anticoagulants/therapies prolonging clotting time (unwilling or unable to discontinue). 11.Inability to communicate or comply with instructions. 12.Other investigator-determined contraindications.

Design outcomes

Primary

MeasureTime frame
Proportion of subjects with rosacea improvement;

Secondary

MeasureTime frame
Proportion of subjects with rosacea improvement;

Countries

China

Contacts

Public ContactWu Lin

Peking University Shenzhen Hospital

119544648@qq.com+86 135 1016 9619

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026