AgingPhase 2NCT00520910
Efficacy of Polypodium Leucotomos Extract Decreasing UVA Premutagenic and Photoaging Markers
A Phase 2 study testing Polypodium leucotomos in people with Aging and Skin Abnormalities, run by University of Miami at 1 site in United States.
Trial summary
With this study, the investigators will like to determine if taking a dose of the study medication, called Polypodium leucotomos (PL), prevents some of the changes in the skin caused by the adverse effects of UVA, a type of ultraviolet light. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Skin Abnormalities
- What is being tested?
- Polypodium leucotomos
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to May 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects,
- 18 years of age or older,
- with Fitzpatrick skin types II and III.
Who cannot join
- Pregnancy
- Personal history of skin cancer
- History of abnormal photosensitivity
- Smokers
- Patients with history or being exposed to other forms of radiation (other than sunlight)
- History or current exposure to asbestos
Show all 10Show fewer
- Patients taking any drug that might alter the response of skin to UVR (including, but are not limited to, doxycycline, sulfas, psoralens, and amiodarone)
- Patients unable to undergo skin biopsies
- History of abnormal scarring
- History of adverse reaction to local anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Skin Research Group Office
Miami, Florida, 33136
About this study
Official title: Single-Blind Study Determining the Efficacy of Polypodium Leucotomos Extract Supplement in Decreasing UVA Premutagenic and Photoaging Markers
With this study, the investigators will like to determine if taking a dose of the study medication, called Polypodium leucotomos (PL), prevents some of the changes in the skin caused by the adverse effects of UVA, a type of ultraviolet light.
- Conditions
- Aging, Skin Abnormalities
- Being tested
- Polypodium leucotomos
- Keywords
- Polypodium leucotomos, Ultraviolet Rays, Heliocare, calaguala, anapsos, Skin Aging and Damage
- Medical subject headings
- Skin Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polypodium leucotomosDrug
Also called Heliocare
Subject is given a 7.5 mg/kg oral dose of Polypodium leucotomos during Baseline visit, and again at 8 hours and 2 hours before the Follow-up visit #2.
| Study group | Role | What they receive |
|---|---|---|
| Polypodium leucotomos extract | Experimental | Subject is given a 7.5 mg/kg dose of Polypodium leucotomos. Receives: Drug: Polypodium leucotomos |
| No intervention | No intervention | Subject is not given any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample
CD is determined by semiquantitative real-time polymerase chain reaction.
Measured: baseline, 24 hours
8-oxo-7,8-dihydro-2'-Deoxyguanosine (8-oxo-dG) Quantification in Skin Biopsy Sample Taken From Final Visit
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert S. Kirsner, University of Miami
- Investigators
- Brian Berman, M.D., Ph.D., Principal investigator, University of Miami, Department of Dermatology and Cutaneous Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520910
- Sponsor's protocol ID
- 20070203
- Status last verified
- Jun 2019
- First submitted
- 24 Aug 2007
- Last updated
- 18 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Philips N, Smith J, Keller T, Gonzalez S. Predominant effects of Polypodium leucotomos on membrane integrity, lipid peroxidation, and expression of elastin and matrixmetalloproteinase-1 in ultraviolet radiation exposed fibroblasts, and keratinocytes. J Dermatol Sci. 2003 Jun;32(1):1-9. doi: 10.1016/s0923-1811(03)00042-2.
PubMed 12788523Gombau L, Garcia F, Lahoz A, Fabre M, Roda-Navarro P, Majano P, Alonso-Lebrero JL, Pivel JP, Castell JV, Gomez-Lechon MJ, Gonzalez S. Polypodium leucotomos extract: antioxidant activity and disposition. Toxicol In Vitro. 2006 Jun;20(4):464-71. doi: 10.1016/j.tiv.2005.09.008. Epub 2005 Nov 2.
PubMed 16263237Alonso-Lebrero JL, Dominguez-Jimenez C, Tejedor R, Brieva A, Pivel JP. Photoprotective properties of a hydrophilic extract of the fern Polypodium leucotomos on human skin cells. J Photochem Photobiol B. 2003 Apr;70(1):31-7. doi: 10.1016/s1011-1344(03)00051-4.
PubMed 12745244Middelkamp-Hup MA, Pathak MA, Parrado C, Garcia-Caballero T, Rius-Diaz F, Fitzpatrick TB, Gonzalez S. Orally administered Polypodium leucotomos extract decreases psoralen-UVA-induced phototoxicity, pigmentation, and damage of human skin. J Am Acad Dermatol. 2004 Jan;50(1):41-9. doi: 10.1016/s0190-9622(03)02732-4.
PubMed 14699363Middelkamp-Hup MA, Pathak MA, Parrado C, Goukassian D, Rius-Diaz F, Mihm MC, Fitzpatrick TB, Gonzalez S. Oral Polypodium leucotomos extract decreases ultraviolet-induced damage of human skin. J Am Acad Dermatol. 2004 Dec;51(6):910-8. doi: 10.1016/j.jaad.2004.06.027.
PubMed 15583582Agar NS, Halliday GM, Barnetson RS, Ananthaswamy HN, Wheeler M, Jones AM. The basal layer in human squamous tumors harbors more UVA than UVB fingerprint mutations: a role for UVA in human skin carcinogenesis. Proc Natl Acad Sci U S A. 2004 Apr 6;101(14):4954-9. doi: 10.1073/pnas.0401141101. Epub 2004 Mar 23.
PubMed 15041750Berneburg M, Gattermann N, Stege H, Grewe M, Vogelsang K, Ruzicka T, Krutmann J. Chronically ultraviolet-exposed human skin shows a higher mutation frequency of mitochondrial DNA as compared to unexposed skin and the hematopoietic system. Photochem Photobiol. 1997 Aug;66(2):271-5. doi: 10.1111/j.1751-1097.1997.tb08654.x.
PubMed 9277148
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Blind Study Determining the Efficacy of Polypodium Leucotomos Extract Supplement in Decreasing UVA Premutagenic and Photoaging Markers
- ClinicalTrials.gov ID
- NCT00520910
- Acronym / sponsor ID
- 20070203
- Conditions
- Aging, Skin Abnormalities
- Keywords
- Polypodium leucotomos, Ultraviolet Rays, Heliocare, calaguala, anapsos, Skin Aging and Damage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Aug 2007 (actual)
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 27 Aug 2007 (estimated)
- Results
- Posted 18 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With this study, the investigators will like to determine if taking a dose of the study medication, called Polypodium leucotomos (PL), prevents some of the changes in the skin caused by the adverse effects of UVA, a type of ultraviolet light.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polypodium leucotomos extract | Experimental | Drug: Polypodium leucotomosSubject is given a 7.5 mg/kg dose of Polypodium leucotomos. |
| No intervention | No intervention | –Subject is not given any treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy subjects,
- 18 years of age or older,
- with Fitzpatrick skin types II and III.
Key exclusion criteria (10 listed)
- Pregnancy
- Personal history of skin cancer
- History of abnormal photosensitivity
- Smokers
- Patients with history or being exposed to other forms of radiation (other than sunlight)
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 |
|---|---|---|
| Polypodium leucotomosAlso: HeliocareSubject is given a 7.5 mg/kg oral dose of Polypodium leucotomos during Baseline visit, and again at 8 hours and 2 hours before the Follow-up visit #2. | Drug | Polypodium leucotomos extract |
Primary outcome
Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample
Time frame: baseline, 24 hours
CD is determined by semiquantitative real-time polymerase chain reaction.
8-oxo-7,8-dihydro-2'-Deoxyguanosine (8-oxo-dG) Quantification in Skin Biopsy Sample Taken From Final Visit
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12788523Philips N, Smith J, Keller T, Gonzalez S. Predominant effects of Polypodium leucotomos on membrane integrity, lipid peroxidation, and expression of elastin and matrixmetalloproteinase-1 in ultraviolet radiation exposed fibroblasts, and keratinocytes. J Dermatol Sci. 2003 Jun;32(1):1-9. doi: 10.1016/s0923-1811(03)00042-2.
- Background: PubMed 16263237Gombau L, Garcia F, Lahoz A, Fabre M, Roda-Navarro P, Majano P, Alonso-Lebrero JL, Pivel JP, Castell JV, Gomez-Lechon MJ, Gonzalez S. Polypodium leucotomos extract: antioxidant activity and disposition. Toxicol In Vitro. 2006 Jun;20(4):464-71. doi: 10.1016/j.tiv.2005.09.008. Epub 2005 Nov 2.
- Background: PubMed 12745244Alonso-Lebrero JL, Dominguez-Jimenez C, Tejedor R, Brieva A, Pivel JP. Photoprotective properties of a hydrophilic extract of the fern Polypodium leucotomos on human skin cells. J Photochem Photobiol B. 2003 Apr;70(1):31-7. doi: 10.1016/s1011-1344(03)00051-4.
- Background: PubMed 14699363Middelkamp-Hup MA, Pathak MA, Parrado C, Garcia-Caballero T, Rius-Diaz F, Fitzpatrick TB, Gonzalez S. Orally administered Polypodium leucotomos extract decreases psoralen-UVA-induced phototoxicity, pigmentation, and damage of human skin. J Am Acad Dermatol. 2004 Jan;50(1):41-9. doi: 10.1016/s0190-9622(03)02732-4.
- Background: PubMed 15583582Middelkamp-Hup MA, Pathak MA, Parrado C, Goukassian D, Rius-Diaz F, Mihm MC, Fitzpatrick TB, Gonzalez S. Oral Polypodium leucotomos extract decreases ultraviolet-induced damage of human skin. J Am Acad Dermatol. 2004 Dec;51(6):910-8. doi: 10.1016/j.jaad.2004.06.027.
- Background: PubMed 15041750Agar NS, Halliday GM, Barnetson RS, Ananthaswamy HN, Wheeler M, Jones AM. The basal layer in human squamous tumors harbors more UVA than UVB fingerprint mutations: a role for UVA in human skin carcinogenesis. Proc Natl Acad Sci U S A. 2004 Apr 6;101(14):4954-9. doi: 10.1073/pnas.0401141101. Epub 2004 Mar 23.
- Background: PubMed 9277148Berneburg M, Gattermann N, Stege H, Grewe M, Vogelsang K, Ruzicka T, Krutmann J. Chronically ultraviolet-exposed human skin shows a higher mutation frequency of mitochondrial DNA as compared to unexposed skin and the hematopoietic system. Photochem Photobiol. 1997 Aug;66(2):271-5. doi: 10.1111/j.1751-1097.1997.tb08654.x.
- Skin Research Group WebsiteLink provided by the sponsor.
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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.
Brian Berman, M.D., Ph.D. principal investigator
University of Miami, Department of Dermatology and Cutaneous Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polypodium leucotomos in people with Aging and Skin Abnormalities, run by University of Miami at 1 site in United States.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample (time frame: baseline, 24 hours). The study lists 2 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 NCT00520910, which also lists 7 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 18 Jun 2019; AzTrials last refreshed its copy on 8 Nov 2026.