NCT00580736

Brief Summary

The research hypothesis is that topical application of a mixture of pre-polymers of polypropylene glycol and polyethylene glycol (an optical clearing agent) will reduce skin light scattering, increasing the amount of light reaching the target for diagnostic as well as therapeutic purposes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

4.3 years

First QC Date

December 18, 2007

Last Update Submit

October 19, 2022

Conditions

Port Wine StainNevus of OtaTattoosScarsAcneHypertrichosisSebaceous Gland Diseases

Keywords

sebaceous hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Outcome measure is to evaluate the optical clearing effects of the combination mixture of pre-polymers of polypropylene glycol and polyethylene glycol.

    8 weeks

Study Arms (1)

Optical Clearing

EXPERIMENTAL

Optical Clearing

Device: Optical Clearing

Interventions

Optical ClearingDEVICE

Optical Clearing

Optical Clearing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult 18 years and older
  • Lesion diagnoses in an area measuring 3 cm2 or more on any body site
  • Apparent good health

You may not qualify if:

  • Pregnant women
  • History of cutaneous photosensitivity
  • History of photodermatoses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beckman Laser Institute Medical and Surgical Clinic

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Port-Wine StainNevus of OtaCicatrixAcne VulgarisHypertrichosisSebaceous Gland Diseases

Condition Hierarchy (Ancestors)

Skin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue DiseasesNevus, PigmentedNevusNevi and MelanomasNeoplasms by Histologic TypeNeoplasmsFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAcneiform EruptionsHair Diseases

Study Officials

  • Kristen M Kelly, M.D

    Beckman Laser Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kristen Kelly, M.D., Professor Departments of Dermatology and Surgery

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 27, 2007

Study Start

March 1, 2004

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations

US(1)