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

July 23, 2024 updated by: Shanghai Dermatology Hospital
The Application of Bovine Basic Fibroblast Growth Factor Gel in the Treatment of Sensitive Skin

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Skin Disease Hospital
        • Contact:
          • Haiyan Zhang, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Sensitive skin with a diagnosis of persistent erythema and a lactate irritation test score of 2-3
  2. 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
  3. Physical sunscreen should be strict during enrollment

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Application of Bovine Basic Fibroblast Growth Factor Gel
Drug: bFGF
Half-face randomized control
Placebo Comparator: Bovine Basic Gel
Drug: Bovine Basic Gel
Bovine Basic Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
erythema index
Time Frame: 0、1、2、4 week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Dermatology Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2024

Primary Completion (Actual)

July 18, 2024

Study Completion (Estimated)

July 18, 2024

Study Registration Dates

First Submitted

July 18, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-06 (Other Identifier: Incrediwear)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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