CompletedNot Applicable

Combining Broad Based Light (BBL), Fractionated 1927 (MOXI) and Dual Wavelength 2940/1470 (HALO)

United States15 participantsStarted 2024-01-01

Plain-language summary

This is a single-site, non-randomized, non-controlled study at UT Southwestern Medical Center at Dallas in the Department of Plastic Surgery. The study is designed to follow up to 15 consenting subjects who may receive up to 2 BBL/MOXI/HALO treatments under an IRB approved protocol.

Who can participate

Age range20 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy male and female adults between 20-75 years of age
✓. Fitzpatrick skin type 1-4
✓. Individual deemed by the Investigator to benefit from skin resurfacing treatment(s)
✓. Individuals willing to withhold aesthetic therapies that may potentially impact results to the treatment areas for the duration of the study
✓. Women of childbearing potential:
✓.1. will be asked to agree to a pregnancy test before their screening visit in clinic 5.2. must use an acceptable method of birth control
✓. Individuals who can read, speak, write and understand English and who are willing to provide written informed consent.
✓. Individuals willing to sign a photography release with the understanding that their photos may be used during presentations at national conferences and/or published in journals

Exclusion criteria

✕. Fitzpatrick skin type V-VI
✕. Known allergies to general skin care products
✕. Sensitivity to topical local anesthetic
✕. Current or recent history of skin diseases:
✕. Significant scars in the treatment area:

What they're measuring

Change in Brown Spots at 1 Month From Baseline (Single Treatment Group)

Timeframe: Baseline, 1 Month

Change in Brown Spots at 3 Months From Baseline (Single Treatment Group)

Timeframe: Baseline, 3 Months

Change in Brown Spots at 1 Month From Baseline (Double Treatment Group)

Timeframe: Baseline, 1 Month

Change in Brown Spots at 3 Months From Baseline (Double Treatment Group)

Timeframe: Baseline, 3 Months

Change in Pores at 1 Month From Baseline (Single Treatment Group)

Timeframe: Baseline, 1 Month

Change in Pores at 3 Months From Baseline (Single Treatment Group)

Timeframe: Baseline, 3 Months

Change in Pores at 1 Month From Baseline (Double Treatment Group)

Timeframe: Baseline, 1 Month

Change in Pores at 3 Months From Baseline (Double Treatment Group)

Trial details

NCT IDNCT06091215

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-11

Results submitted2025-06-04

View on ClinicalTrials.gov More Pigment Skin trials

Who can participate

Age range20 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy male and female adults between 20-75 years of age
✓. Fitzpatrick skin type 1-4
✓. Individual deemed by the Investigator to benefit from skin resurfacing treatment(s)
✓. Individuals willing to withhold aesthetic therapies that may potentially impact results to the treatment areas for the duration of the study
✓. Women of childbearing potential:
✓.1. will be asked to agree to a pregnancy test before their screening visit in clinic 5.2. must use an acceptable method of birth control
✓. Individuals who can read, speak, write and understand English and who are willing to provide written informed consent.
✓. Individuals willing to sign a photography release with the understanding that their photos may be used during presentations at national conferences and/or published in journals

Exclusion criteria

✕. Fitzpatrick skin type V-VI
✕. Known allergies to general skin care products
✕. Sensitivity to topical local anesthetic
✕. Current or recent history of skin diseases:
✕. Significant scars in the treatment area:

What they're measuring

Change in Brown Spots at 1 Month From Baseline (Single Treatment Group)

Timeframe: Baseline, 1 Month

Change in Brown Spots at 3 Months From Baseline (Single Treatment Group)

Timeframe: Baseline, 3 Months

Change in Brown Spots at 1 Month From Baseline (Double Treatment Group)

Timeframe: Baseline, 1 Month

Change in Brown Spots at 3 Months From Baseline (Double Treatment Group)

Timeframe: Baseline, 3 Months

Change in Pores at 1 Month From Baseline (Single Treatment Group)

Timeframe: Baseline, 1 Month

Change in Pores at 3 Months From Baseline (Single Treatment Group)

Timeframe: Baseline, 3 Months

Change in Pores at 1 Month From Baseline (Double Treatment Group)

Timeframe: Baseline, 1 Month

Change in Pores at 3 Months From Baseline (Double Treatment Group)