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A self-controlled single-center clinical study to evaluate the effectiveness of carbon dioxide fractional laser combined with recombinant human type III collagen hydrogel in the treatment of hypertrophic scars

A self-controlled single-center clinical study to evaluate the effectiveness of carbon dioxide fractional laser combined with recombinant human type III collagen hydrogel in the treatment of hypertrophic scars

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035153
Enrollment
Unknown
Registered
2020-08-02
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-09-07

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

Conditions

Hypertrophic scar

Interventions

trial group:Carbon dioxide fractional laser combined with recombinant human type III collagen hydrogel
control group:Carbon dioxide fractional laser

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 99 Years

Inclusion criteria

Inclusion criteria: (1) The scar area is less than 5% TBSA, regardless of gender; (2) The scar has been formed for more than 6 months without signs of withdrawal; (3) Scar length >= 8cm, thickness >= 2mm; (4) The part of the scar is flat and the movement is small; (5) Good patient compliance; (6) No laser treatment contraindications; (7) The patient and his family members sign a written informed consent.

Exclusion criteria

Exclusion criteria: (1) The lesions are keloids or keloid tendencies, such as exceeding the original injury edge, irregular boundaries, infiltration into the surrounding normal tissues, and keloid growth; (2) Chronic wounds such as chemical burns, electric burns, diabetes, etc.; (3) Those who are known to have a history of allergies or allergies (allergic to 2 or more allergens) to the ingredients or other chemical structures contained in this product and the reference substance or topical anesthetics; (4) Severe malnutrition, albumin 38.5 degrees C or white blood cell > 12 * 10^9/L; (6) Those who have a serious systemic infection and need to be treated with antibiotics throughout the body; (7) Tumor, radiotherapy or chemotherapy patients; (8) Patients with severe primary diseases and mental illnesses such as cardiovascular, liver, kidney and blood system; (9) Pregnant or lactating women and those who have birth plans; (10) Those who have participated in other clinical research within 1 month before being selected; (11) There are situations in which other researchers think it is inappropriate to participate in clinical research.

Design outcomes

Primary

MeasureTime frame
Change in cross-sectional area of scar;POSAS;

Secondary

MeasureTime frame
Scar recurrence rate;

Countries

China

Contacts

Public ContactSun yu

Shanghai Changhai Hospital

littlefish0916@126.com+86 13816873483

Outcome results

None listed

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