A Phase 2 interventional study of Polypodium leucotomos in Aging and Skin Abnormalities, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-18.
Sponsored by University of Miami · Phase 2, Interventional, and Basic science
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.
39 studies on the registry are indexed under Skin Abnormalities; 7 are open to participants now.
This study's enrollment of 10 is below the median of 39 across 26 interventional studies indexed under Skin Abnormalities.
Browse Skin Abnormalities studies →University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subject is given a 7.5 mg/kg dose of Polypodium leucotomos.
Drug: Polypodium leucotomos
Subject is not given any treatment.
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.
Also known as: Heliocare
Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample
CD is determined by semiquantitative real-time polymerase chain reaction.
Time frame: baseline, 24 hours
8-oxo-7,8-dihydro-2'-Deoxyguanosine (8-oxo-dG) Quantification in Skin Biopsy Sample Taken From Final Visit
Time frame: 24 hours
| Milestone | Polypodium Leucotomos Extract | No Intervention |
|---|---|---|
| Started | 5 | 5 |
| Completed | 5 | 5 |
| Not completed | 0 | 0 |
CD is determined by semiquantitative real-time polymerase chain reaction.
| percent change | Polypodium Leucotomos Extract | No Intervention |
|---|---|---|
| Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample | -84 ± NA | 217 ± NA |
No measurements were reported for this outcome.
Collected over 24 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Polypodium Leucotomos Extract | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| No Intervention | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | Polypodium Leucotomos Extract | No Intervention | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 5 | 10 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Polypodium Leucotomos Extract | No Intervention | Total |
|---|---|---|---|
| Female | — | — | 0 |
| Male | — | — | 0 |
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Phlebodium aureum