Skip to content

A clinical trial aiming to evaluate the efficacy and safety of the application of compress in repairing skin barrier injury

A single-center, randomized, parallel controlled, assessor-blinded, superiority clinical trial aiming to evaluate the efficacy and safety of the application of recombinant collagen in repairing skin barrier injury

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091943
Enrollment
Unknown
Registered
2024-11-06
Start date
2024-11-11
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Skin barrier injury

Interventions

Test Group:Use of recombinant collagen dressing
Control group:Medical ice pack

Sponsors

The First Affiliated Hospital, Jinan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Adults between the ages of 18 and 60 (including 60 years old, gender is not limited); 2.Subjects who intend to receive Facial Intense Pulsed Light/Chemical Peel treatment; 3.Subjects who have not taken oral medications such as isotretinoin, glucocorticoids, and tranexamic acid within the past 4 weeks; 4.Subjects are willing to comply with the requirements of the study and provide signed written informed consent, etc; 5.Subjects who can complete the entire follow-up process and answer the questionnaire

Exclusion criteria

Exclusion criteria: 1.Suffering from a disease that seriously affects the healing of wounds; 2.Subjects who work outdoors for long periods of time or require prolonged exposure to sunlight after treatment; 3.People who are allergic or hypersensitive to the ingredients of the products used in the clinical trial; 4.Intense pulsed light, superficial peels or other exfoliative treatments (e.g. fruit acids in concentrations of 10% and less or salicylic acid in concentrations of less than 2%, etc.) on the face within 3 months prior to the screening period or within 2 weeks after the planned procedure; 5.Botulinum toxin, aesthetic treatments, energy-based devices other than photomodulation and intense pulsed light (e.g. lasers, radiofrequency, ultrasound, etc.), dermabrasion, chemical peels of intermediate or greater depth, or other exfoliating treatments (e.g. trichloroacetic acid, carbolic acid, fruit acids of 10% and higher concentration, or salicylic acid of 2% and higher concentration, etc.) to the face within the last 6 months prior to the screening period, or within the last 2 weeks after the planned procedure. 6.Facial skin treated with other temporary fillers such as hyaluronic acid or collagen injection therapy within 12 months prior to screening or within 2 weeks after the planned procedure (refer to exclusion criterion 4 for mesotherapy), or any other permanent or semi-permanent filler filler filler (e.g., calcium hydroxyapatite, poly(L-lactic acid), poly(methylmethacrylate), organosilicone, expanded poly(teflonethylene), poly(caprolactone), autologous lipo-filling, face Lifting (including threading), etc. 7.Those with serious cardiac, hepatic, renal and haematological co-morbidities, complications and serious systemic infections at the time of screening; 8.Subjects with a history of severe psychological and psychiatric disorders; 9.Subjects with cancerous skin lesions or ulceration or inflammation of the skin; 10.Subjects with active herpes simplex at screening; 11.Subjects unwilling to sign the informed consent form; 12.Other conditions that the investigator considers inappropriate to participate in this trial; 13.Women who are planning a pregnancy within 2 weeks of screening, or are breastfeeding or pregnant; 14.Subjects who have participated in other clinical trials within 30 days prior to the screening period;

Design outcomes

Primary

MeasureTime frame
The repair rate of skin barrier damage;

Secondary

MeasureTime frame
Skin Roughness Scale;Water content of stratum corneum, Skin elasticity, Trans Epidermal Water Loss(TEWL);Objective index mesured by VISIA;VAS Assessment;Composite scale score reflecting temporary improvement in dry skin and dull complexion;Incidence of adverse events and serious adverse events;

Countries

China

Contacts

Public ContactLiu Hongwei

The First Affiliated Hospital, Jinan University

liuhongwei0521@hotmail.com+86 13318882096

Outcome results

None listed

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