Photoaging of SkinNCT05854628
The Role of Red Flavonoid in Photoaging
A study testing skin biopsy in people with Photoaging of Skin and Skin Aging, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Photoaging of Skin, Skin Aging
- What is being tested?
- skin biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Photoaging of Skin, Skin Aging
- Being tested
- skin biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsyProcedure or surgery
Skin biopsies will be obtained at different time points.
| Study group | Role | What they receive |
|---|---|---|
| 0.1% red flavonoids facial cream | Experimental | 0.1% red flavonoids facial cream Receives: Procedure: skin biopsy |
| Placebo facial cream | Placebo comparator | Placebo moisturizing facial cream Receives: Procedure: skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks, 16 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study startOct 2023 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Why it stopped: We decided not to proceed further to enroll patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Photoaging of SkinStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Amorepacific Corporation
- Responsible party
- Sponsor
- Investigators
- Anna Chien, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854628
- Sponsor's protocol ID
- IRB00384338
- Status last verified
- Dec 2023
- First submitted
- 12 Apr 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35499017An 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.
PubMed 33229519Kim 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.
PubMed 36252351Mukherjee 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.
PubMed 18046911Sitohang 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.
PubMed 35620028
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Red Flavonoid in Photoaging
- ClinicalTrials.gov ID
- NCT05854628
- Acronym / sponsor ID
- IRB00384338
- Conditions
- Photoaging of Skin, Skin Aging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We decided not to proceed further to enroll patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Amorepacific Corporation
- Study start
- Oct 2023 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 0.1% red flavonoids facial cream | Experimental | Procedure: skin biopsy0.1% red flavonoids facial cream |
| Placebo facial cream | Placebo comparator | Procedure: skin biopsyPlacebo moisturizing facial cream |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin biopsySkin biopsies will be obtained at different time points. | Procedure or surgery | 0.1% red flavonoids facial cream, Placebo facial cream |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Results publication: PubMed 35499017Pereira 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.
- Results publication: PubMed 33229519An 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.
- Results publication: PubMed 36252351Kim 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.
- Results publication: PubMed 18046911Mukherjee 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.
- Results publication: PubMed 35620028Sitohang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Chien, MD principal investigator
Johns Hopkins School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing skin biopsy in people with Photoaging of Skin and Skin Aging, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibrillin-1 fold change as determined by Reverse Transcription Polymerase Chain Reaction (RT-PCR) (time frame: 8 weeks, 16 weeks, 24 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05854628, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.