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NCT03565146 · ClinicalTrials.gov registry record · NA
Evaluation of the Efficacy and Safety of PiQo4 System for the Treatment of Pigmented Lesions
A NA study of Pigmentation, sponsored by Focus Medical.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT03565146: Completed NA study of Pigmentation, sponsored by Focus Medical.
NCT03565146 is a NA study of Pigmentation that has completed, run by Focus Medical. The registered enrollment target is 25 participants, below the 43-participant average among 4 other Pigmentation trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03565146, a NA study of Pigmentation, has completed, sponsored by Focus Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
A total of at least 25 healthy subjects at a single site, aged 21-70 years old with congenital or acquired challenging/resistant, age/sun-related flat and benign facial pigmentation with or without hand pigmentation who wish to improve their skin appearance.
Primary Outcome
Facial Pigmentation Improvement evaluated by the investigator at the 1 month follow up visit compared to baseline using a 5-point improvement scale where a score of between 0 and 4 will be assigned (0-No improvement; 1- Trace to mild improvement of some lesions; 2- Moderate response: some lesions lighter; 3- Good response: most lesions much lighter; 4 - excellent response: most or all lesions are much lighter or gone)
Conditions Studied
Interventions
- DEVICE PiQo4 Laser System
Study Locations (1)
Texas
- Westlake Dermatology - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2018-06-29 |
| Est. Completion | 2019-06-05 |
| Phase | NA |
What the finished NCT03565146 record still lists
NCT03565146 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 43-participant average among 4 other Pigmentation trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Pigmentation appearing as the primary indexed condition, and to 1 intervention - of which PiQo4 Laser System is the first listed.
NCT03565146 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03565146 about?
NCT03565146 is a clinical study titled "Evaluation of the Efficacy and Safety of PiQo4 System for the Treatment of Pigmented Lesions". A total of at least 25 healthy subjects at a single site, aged 21-70 years old with congenital or acquired challenging/resistant, age/sun-related flat and benign facial pigmentation with or without hand pigmentation who wish to improve their skin appearance.
What is the current status of trial NCT03565146?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2018-06-29. Estimated completion is 2019-06-05.
What conditions does trial NCT03565146 study?
This clinical trial studies the following conditions: Pigmentation.
What interventions are being tested in trial NCT03565146?
The interventions under investigation include: PiQo4 Laser System (DEVICE).
Who is sponsoring clinical trial NCT03565146?
This trial is sponsored by Focus Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03565146 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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