The Role of Red Flavonoid in Photoaging

NCT05854628 | Withdrawn

• 1 other identifier: IRB00384338
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Photoaging of Skin; Skin Aging

Outcome Measures

Primary Outcomes (8)

• Fibrillin-1 fold change as determined by Reverse Transcription Polymerase Chain Reaction (RT-PCR)

  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)

  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)

  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)

  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

  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

  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

  Loss of elasticity will be graded as absent, localized or diffuse.

  8 weeks, 16 weeks, 24 weeks

• Brightness as assessed by clinical assessments

  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

Study Arms (2)

0.1% red flavonoids facial cream

EXPERIMENTAL

0.1% red flavonoids facial cream

Procedure: skin biopsy

Placebo facial cream

PLACEBO COMPARATOR

Placebo moisturizing facial cream

Procedure: skin biopsy

Interventions

skin biopsy PROCEDURE

Skin biopsies will be obtained at different time points.

0.1% red flavonoids facial cream; Placebo facial cream

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Amorepacific Corporation: collaborator

Related Publications (5)

• Pereira AG, Garcia-Perez P, Cassani L, Chamorro F, Cao H, Barba FJ, Simal-Gandara J, Prieto MA. Camellia japonica: A phytochemical perspective and current applications facing its industrial exploitation. Food Chem X. 2022 Feb 17;13:100258. doi: 10.1016/j.fochx.2022.100258. eCollection 2022 Mar 30.

  PMID: 35499017 RESULT

• An S, Cho SY, Kang J, Lee S, Kim HS, Min DJ, Son E, Cho KH. Inhibition of 3-phosphoinositide-dependent protein kinase 1 (PDK1) can revert cellular senescence in human dermal fibroblasts. Proc Natl Acad Sci U S A. 2020 Dec 8;117(49):31535-31546. doi: 10.1073/pnas.1920338117. Epub 2020 Nov 23.

  PMID: 33229519 RESULT

• Kim J, Kim HS, Choi DH, Choi J, Cho SY, Kim SH, Baek HS, Yoon KD, Son SW, Son ED, Hong YD, Ko J, Cho SY, Park WS. Kaempferol tetrasaccharides restore skin atrophy via PDK1 inhibition in human skin cells and tissues: Bench and clinical studies. Biomed Pharmacother. 2022 Dec;156:113864. doi: 10.1016/j.biopha.2022.113864. Epub 2022 Oct 14.

  PMID: 36252351 RESULT

• Mukherjee S, Date A, Patravale V, Korting HC, Roeder A, Weindl G. Retinoids in the treatment of skin aging: an overview of clinical efficacy and safety. Clin Interv Aging. 2006;1(4):327-48. doi: 10.2147/ciia.2006.1.4.327.

  PMID: 18046911 RESULT

• Sitohang IBS, Makes WI, Sandora N, Suryanegara J. Topical tretinoin for treating photoaging: A systematic review of randomized controlled trials. Int J Womens Dermatol. 2022 Mar 25;8(1):e003. doi: 10.1097/JW9.0000000000000003. eCollection 2022 Mar.

  PMID: 35620028 RESULT

Study Officials

• Anna Chien, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is double blind, neither the participants nor the investigators will be aware of the groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigators will recruit up to 75 participants for the entire study. Approximately half will be randomly assigned to treatment group and half randomly assigned to placebo group. The treatment group participants will be given 0.1% red flavonoids facial cream while the control cohort will be given a placebo facial cream.

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 11, 2023
• Study Start: October 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share