The Role of Red Flavonoid in Photoaging

December 13, 2023 updated by: Johns Hopkins University

The goal of this clinical trial is to learn about the effects of "red flavonoid" substance on skin, which is extracted from a plant called Camellia japonica, in adults aged of 45 or older with photo-damaged skin.

The main questions it aims to answer are:

  • Does red flavonoid have an anti-aging effect?
  • Does red flavonoid have any skin quality-improving effects? Participants will
  • Be using creams with or without red flavonoid (only moisturizing creams) and sun-screen for the duration of the study.
  • Get a skin biopsy before and after using the creams.
  • Be taken photos of the face and neck region and have a skin examination at each visit.
  • Complete a self-questionnaire at final visit. Researchers will compare the group who uses red flavonoid facial cream with the group who uses moisturizing cream to see if red flavonoid has an effect on appearance and structure.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to investigate the anti-photoaging effects of red flavonoid, a product with natural phytochemical kaempferol tetrasaccharides (KTs) extracted from Camellia japonica. The investigators hypothesize that Red flavonoids extracted from Camellia japonica will present anti-aging effects, such as skin smoothening, increased elasticity, and brightening, with high subjective participant satisfaction and microscopically corroborating analyses.

Individuals will be recruited from patient populations seen at the general dermatology clinics of Johns Hopkins Department of Dermatology or from patient populations participating in Johns Hopkins Cutaneous Translational Research Program (CTReP) research studies. Study procedures will be conducted at the Johns Hopkins CTReP office located at the Johns Hopkins Outpatient Center. Once eligibility has been demonstrated, the potential subjects will be instructed to make the first study appointment. This feasibility study will have a study population of up to 75 individuals over the age of 45. Each study participant will have up to 7 on-site visits within 24 weeks. A facial cream with or without 0.1% red flavonoid will be provided for twice-daily use. At various time points, photographs and clinical assessments will be collected as well as punch biopsy samples for laboratory study.

At the discretion of the principal investigator, biopsies may be taken from subjects before and following daily usage of the product of interest, up to 8 biopsies in total. The timepoints may be adjusted as data is being collected. A punch biopsy procedure will be employed which is a routine dermatological procedure consisting of local anesthesia, followed by the punch, which cuts a cylindrical core of epidermis, dermis, and subcutaneous tissue. A biopsy size of up to 4-mm in diameter is considered enough to perform all tests required by this protocol. After removal of the tissue sample, a suture is placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications and blends well with the surrounding skin.

Standardized digital photographs will be obtained by study staff using a digital camera and software under standard photographic conditions at each study visit. Participants' eyes will be blacked out to de-identify photos. Photograph files will be coded to remove personal identifiers and stored on a secure hard drive in CTReP.

Non-invasive clinical assessments will be performed to 1) record skin findings using graded scales if needed, 2) to identify suitable areas for biopsy, 3) give information/demonstration about the product of interest, 4) to identify occurrence of any adverse events and 5) record post treatment findings.

Tissue work-up may include, but not limited to hematoxylin and eosin staining for assessment of epidermal/dermal thickness, reverse transcription-polymerase chain reaction and immunohistochemistry for photoaging and pigmentation markers such as fibrillin-1, collagen type IV, or collagen type I, and tyrosinase.

Any clinical findings determined by the Investigator to be important and/or unusual will be referred to as an adverse event. Study participants are asked to contact clinic staff immediately if the participants experience a reaction to the topical applications at any time during the study. Expected reactions may be documented in a problem events log. The investigator will use his discretion to remove participants from the study, and all problem events will be reported to Institutional Review Board.

Differences in protein expression between the test sites, and after application of test substances for varying periods of time, will be assessed for significance using either Student's t-test or analysis of variance (or non-parametric equivalents, if necessary) depending on the comparison required.

Study Type

Interventional

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.

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Moderate to severe photo-aged skin that is within the Fitzpatrick skin types 1-6
  • Must be healthy enough to undergo skin biopsy in the opinion of the investigator
  • Must be willing to comply with the requirements of the protocol
  • Must have the ability to understand and communicate with the investigator
  • Must be able to provide informed consent.

Exclusion Criteria:

  • Subjects who are unable to provide informed consent
  • Subjects with history of keloid scars
  • Subject with significant medical history or current skin diseases that the investigator feels is not safe study participation
  • Subjects who have used products containing salicylic acid, beta hydroxyl acids or vitamins A, C, or E in the last 14 days
  • Subjects who have used topical antibiotics or topical retinoids in the last 30 days
  • Subjects who have had a recent surgical or esthetic procedure in the last 3 months that can affect facial wrinkles or facial hyperpigmentation, such as botulinum toxin injections, chemical peels, laser-based therapies to the face, or face lift surgeries
  • Subjects with allergies to lidocaine or epinephrine
  • Subjects who self-report as nursing/pregnant or planning to be pregnant during the study

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.1% red flavonoids facial cream
Procedure: skin biopsy
Skin biopsies will be obtained at different time points.
Placebo Comparator: Placebo facial cream
Placebo moisturizing facial cream
Procedure: skin biopsy
Skin biopsies will be obtained at different time points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibrillin-1 fold change as determined by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Time Frame: 8 weeks, 16 weeks, 24 weeks
The investigators will detect the fold change of Fibrillin-1 in the basal layer of the epidermis in both skin treated with Red Flavonoids and placebo, by RT-PCR, to determine whether Red Flavonoids can improve skin photodamage and aging.
8 weeks, 16 weeks, 24 weeks
Collagen type-4 fold change as determined by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Time Frame: 8 weeks, 16 weeks, 24 weeks
The investigators will detect the fold change of Collagen type-4 in the basal layer of the epidermis in both skin treated with Red Flavonoids and placebo, by RT-PCR, to determine whether Red Flavonoids can improve skin photodamage and aging.
8 weeks, 16 weeks, 24 weeks
Collagen type-1 fold change as determined by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Time Frame: 8 weeks, 16 weeks, 24 weeks
The investigators will detect the fold change of Collagen type-1 in the basal layer of the epidermis in both skin treated with Red Flavonoids and placebo, by RT-PCR, to determine whether Red Flavonoids can improve skin photodamage and aging.
8 weeks, 16 weeks, 24 weeks
Tyrosinase fold change as determined by Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Time Frame: 8 weeks, 16 weeks, 24 weeks
The investigators will detect the fold change of Tyrosinase in the basal layer of the epidermis in both skin treated with Red Flavonoids and placebo, by RT-PCR, to determine whether Red Flavonoids can improve skin photodamage and aging.
8 weeks, 16 weeks, 24 weeks
Wrinkles/photoaging as assessed by clinical assessments
Time Frame: 8 weeks, 16 weeks, 24 weeks
Griffith's photonumeric scale will be used. It is a nine-point scale where 0 (zero) is no wrinkles/photodamage and 8 is severe wrinkles/photodamage.
8 weeks, 16 weeks, 24 weeks
Hydration as assessed by clinical assessments
Time Frame: 8 weeks, 16 weeks, 24 weeks
Skin hydration will be graded with a five-point scale where 0 (zero) is adequate hydration and 4 is severe dehydration.
8 weeks, 16 weeks, 24 weeks
Loss of elasticity as assessed by clinical assessments
Time Frame: 8 weeks, 16 weeks, 24 weeks
Loss of elasticity will be graded as absent, localized or diffuse.
8 weeks, 16 weeks, 24 weeks
Brightness as assessed by clinical assessments
Time Frame: 8 weeks, 16 weeks, 24 weeks
Brightness improvement rate will be graded with a five-point scale where 0 (zero) is marked improvement and 4 is no improvement.
8 weeks, 16 weeks, 24 weeks

Collaborators and Investigators

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

Sponsor

Johns Hopkins University

Collaborators

Amorepacific Corporation

Investigators

  • Principal Investigator: Anna Chien, MD, Johns Hopkins School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

October 1, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 11, 2023

Study Record Updates

Last Update Posted (Actual)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00384338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Skin Aging

Clinical Trials on skin biopsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe