NCT06516939

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 18, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

July 18, 2024

Last Update Submit

July 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

The Application of Bovine Basic Fibroblast Growth Factor Gel

EXPERIMENTAL
Drug: bFGF

Bovine Basic Gel

PLACEBO COMPARATOR
Drug: Bovine Basic Gel

Interventions

bFGFDRUG

Half-face randomized control

The Application of Bovine Basic Fibroblast Growth Factor Gel

Bovine Basic Gel

Bovine Basic Gel

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Skin Disease Hospital

Shanghai, China

RECRUITING

Central Study Contacts

Haiyan Zhang, MD PhD

CONTACT

xiuli Wang, MD PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2024

First Posted

July 24, 2024

Study Start

June 10, 2024

Primary Completion

July 18, 2024

Study Completion

July 18, 2024

Last Updated

July 24, 2024

Record last verified: 2024-07

Locations