Trial Outcomes & Findings for Efficacy of Polypodium Leucotomos Extract Decreasing UVA Premutagenic and Photoaging Markers (NCT NCT00520910)
NCT ID: NCT00520910
Last Updated: 2019-06-18
Results Overview
CD is determined by semiquantitative real-time polymerase chain reaction.
COMPLETED
PHASE2
10 participants
baseline, 24 hours
2019-06-18
Participant Flow
Participant milestones
| Measure |
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.
|
No Intervention
Subject is not given any treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gender data not collected
Baseline characteristics by cohort
| Measure |
Polypodium Leucotomos Extract
n=5 Participants
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.
|
No Intervention
n=5 Participants
Subject is not given any treatment.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
0 Participants
Gender data not collected
|
|
Sex: Female, Male
Male
|
—
|
—
|
0 Participants
Gender data not collected
|
PRIMARY outcome
Timeframe: baseline, 24 hoursPopulation: 2 excluded from final data (no detectable baseline common deletion values).
CD is determined by semiquantitative real-time polymerase chain reaction.
Outcome measures
| Measure |
Polypodium Leucotomos Extract
n=5 Participants
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.
|
No Intervention
n=3 Participants
Subject is not given any treatment.
|
|---|---|---|
|
Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample
|
-84 percent change
Standard Deviation NA
Sincere efforts were made to obtain the data from the original PI that left the organization, however, no raw data is available for this outcome. The mean data is available in publication, but the SD was not reported.
|
217 percent change
Standard Deviation NA
Sincere efforts were made to obtain the data from the original PI that left the organization, however, no raw data is available for this outcome. The mean data is available in publication, but the SD was not reported.
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: 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.
Outcome measures
Outcome data not reported
Adverse Events
Polypodium Leucotomos Extract
No Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place