The Application of Bovine Basic Fibroblast Growth Factor... | NCT06516939

Studies
The Application of Bovine Basic Fibroblast Growth Factor Gel in the Treatment of Sensitive Skin

NCT06516939

Sponsor

Shanghai Dermatology Hospital

Status

Recruiting

Last Update Posted

Jul 24, 2024Actual

Enrollment

28Estimated

Phase

Not Applicable

Conditions

Sensitive Skin

Interventions

bFGF
Bovine Basic Gel

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2024Actual

Primary Completion Date

Jul 18, 2024Actual

Completion Date

Jul 18, 2024Estimated

First Submitted Date

Jul 18, 2024

First Submission Date that Met QC Criteria

Jul 23, 2024

First Posted Date

Jul 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2024

Last Update Posted Date

Jul 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
The Application of Bovine Basic Fibroblast Growth Factor Gel	Experimental		Drug: bFGF
Bovine Basic Gel	Placebo Comparator		Drug: Bovine Basic Gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bFGF	Drug	Half-face randomized control	The Application of Bovine Basic Fibroblast Growth Factor Gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
erythema index	The change rate in lesion clearance of face at 1 month after treatment will be measured as the primary outcome	0、1、2、4 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sensitive skin with a diagnosis of persistent erythema and a lactate irritation test score of 2-3
No related skin care products including bovine alkaline fibroblast growth factor were used within 1 month before participating in the experiment, and photoelectric treatment measures were not carried out
Physical sunscreen should be strict during enrollment

Exclusion Criteria:

Children
Have serious heart, liver, kidney, and blood system diseases, and severe immunocompromise
Patients with mental illness or cancer
Those who have received glucocorticoids, calcineurin inhibitors, topical small molecule drugs, antibiotics or tretinoin within 3 months
Those who are allergic to basic fibroblast growth factor gel and its components
Acute dermatitis of the face and perifolliculitis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Haiyan Zhang, MD PhD	Contact	18017336573		zhanghaiyan10842@163.com
xiuli Wang, MD PhD	Contact	18017336663		wangxiuli20150315@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Skin Disease Hospital	Recruiting	Shanghai			China