Aging, Skin Abnormalities
Conditions
Keywords
Polypodium leucotomos, Ultraviolet Rays, Heliocare, calaguala, anapsos, Skin Aging and Damage
Brief 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.
Interventions
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.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects, * 18 years of age or older, * with Fitzpatrick skin types II and III.
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample | 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 | 24 hours | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Polypodium Leucotomos Extract Subject is given a 7.5 mg/kg dose of Polypodium leucotomos.
Polypodium leucotomos: 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. | 5 |
| No Intervention Subject is not given any treatment. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | No Intervention | Total | Polypodium Leucotomos Extract |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Female | — | 0 Participants | — |
| Sex: Female, Male Male | — | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
8-oxo-7,8-dihydro-2'-Deoxyguanosine (8-oxo-dG) Quantification in Skin Biopsy Sample Taken From Final Visit
Time frame: 24 hours
Population: Although data for this outcome measure was collected, however, data are not available. The PI is retired and no longer works in the organization. Sincere efforts were made to obtain the data, however, no data are available for this outcome. Department chair has assume responsibility for this record.
Primary
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
Population: 2 excluded from final data (no detectable baseline common deletion values).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Polypodium Leucotomos Extract | Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample | -84 percent change |
| No Intervention | Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample | 217 percent change |