Adults 20 to 75, any sex, with Pigment Skin. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Brown Spots at 1 Month From Baseline (Single Treatment Group)Primary· Baseline, 1 Month
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects
A lower value signifies improvement
Front
Group
Value
95% CI
Single Treatment Arm
12.00
-2.00 – 17.00
Left Oblique
Group
Value
95% CI
Single Treatment Arm
5.00
-11.00 – 7.00
Nose
Group
Value
95% CI
Single Treatment Arm
0.00
-3.00 – 1.00
Right Oblique
Group
Value
95% CI
Single Treatment Arm
5.00
-11.00 – 5.00
Change in Brown Spots at 3 Months From Baseline (Single Treatment Group)Primary· Baseline, 3 Months
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects
A lower value signifies improvement
Front
Group
Value
95% CI
Single Treatment Arm
8.00
6.00 – 12.00
Left Oblique
Group
Value
95% CI
Single Treatment Arm
.00
-2.00 – 25.00
Nose
Group
Value
95% CI
Single Treatment Arm
3.00
-1.00 – 5.00
Right Oblique
Group
Value
95% CI
Single Treatment Arm
9.00
-2.00 – 25.00
Change in Brown Spots at 1 Month From Baseline (Double Treatment Group)Primary· Baseline, 1 Month
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects
A lower value signifies improvement
Front
Group
Value
95% CI
Double Treatment Arm
-2.00
-14.00 – 0.50
Left Oblique
Group
Value
95% CI
Double Treatment Arm
-3.50
-9.00 – -0.50
Nose
Group
Value
95% CI
Double Treatment Arm
-2.00
-4.50 – -0.50
Right Oblique
Group
Value
95% CI
Double Treatment Arm
-2.50
-16.50 – 12.50
Change in Brown Spots at 3 Months From Baseline (Double Treatment Group)Primary· Baseline, 3 Months
Quantitively assessment of change in overall UV spots using measurements provided VISIA 3D analysis on different sides of the face for all subjects
A lower value signifies improvement
Front
Group
Value
95% CI
Double Treatment Arm
-0.50
-12.00 – 9.00
Left Oblique
Group
Value
95% CI
Double Treatment Arm
-4.00
-9.50 – 6.50
Nose
Group
Value
95% CI
Double Treatment Arm
-0.50
-3.50 – 1.50
Right Oblique
Group
Value
95% CI
Double Treatment Arm
8.50
-14.00 – 22.50
Change in Pores at 1 Month From Baseline (Single Treatment Group)Primary· Baseline, 1 Month
Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects
A lower value signifies improvement.
Front
Group
Value
95% CI
Single Treatment Arm
-5.00
-11.00 – 10.00
Left Oblique
Group
Value
95% CI
Single Treatment Arm
-5.00
-13.00 – 17.00
Nose
Group
Value
95% CI
Single Treatment Arm
-11.00
-21.00 – 3.00
Right Oblique
Group
Value
95% CI
Single Treatment Arm
-3.00
-7.00 – 10.00
Change in Pores at 3 Months From Baseline (Single Treatment Group)Primary· Baseline, 3 Months
Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects
A lower value signifies improvement.
Front
Group
Value
95% CI
Single Treatment Arm
1.00
-34.00 – 14.00
Left Oblique
Group
Value
95% CI
Single Treatment Arm
-1.00
-6.00 – 17.00
Nose
Group
Value
95% CI
Single Treatment Arm
1.00
-15.00 – 5.00
Right Oblique
Group
Value
95% CI
Single Treatment Arm
-7.00
-21.00 – 3.00
Change in Pores at 1 Month From Baseline (Double Treatment Group)Primary· Baseline, 1 Month
Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects
A lower value signifies improvement
Front
Group
Value
95% CI
Double Treatment Arm
2.50
-41.00 – 23.50
Left Oblique
Group
Value
95% CI
Double Treatment Arm
-27.50
-72.00 – 10.00
Nose
Group
Value
95% CI
Double Treatment Arm
-10.00
-28.00 – -5.50
Right Oblique
Group
Value
95% CI
Double Treatment Arm
-17.00
-60.00 – 34.00
Change in Pores at 3 Months From Baseline (Double Treatment Group)Primary· Baseline, 3 Months
Quantitively assessment of change in overall pore count using measurements provided VISIA 3D analysis on different sides of the face for all subjects
A lower value signifies improvement.
Front
Group
Value
95% CI
Double Treatment Arm
-0.00
-0.00 – -0.00
Left Oblique
Group
Value
95% CI
Double Treatment Arm
-0.00
-0.00 – 0.00
Nose
Group
Value
95% CI
Double Treatment Arm
-0.00
-0.01 – 0.00
Right Oblique
Group
Value
95% CI
Double Treatment Arm
-0.00
-0.00 – 0.00
Change in Porphyrins at 1 Month From Baseline (Single Treatment Group)Primary· Baseline, 1 Month
Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects
A lower value signifies improvement.
Front
Group
Value
95% CI
Single Treatment Arm
17.00
-292.00 – 217.00
Left Oblique
Group
Value
95% CI
Single Treatment Arm
51.00
-381.00 – 331.00
Nose
Group
Value
95% CI
Single Treatment Arm
15.00
-49.00 – 66.00
Right Oblique
Group
Value
95% CI
Single Treatment Arm
4.00
-290.00 – 351.00
Change in Porphyrins at 3 Months From Baseline (Single Treatment Group)Primary· Baseline, 3 Months
Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects
A lower value signifies improvement.
Front
Group
Value
95% CI
Single Treatment Arm
-123.00
-365.00 – 272.00
Left Oblique
Group
Value
95% CI
Single Treatment Arm
-192.00
-446.00 – 99.00
Nose
Group
Value
95% CI
Single Treatment Arm
32.00
-19.00 – 88.00
Right Oblique
Group
Value
95% CI
Single Treatment Arm
-114.00
-420.00 – 136.00
Change in Porphyrins at 1 Month From Baseline (Double Treatment Group)Primary· Baseline, 1 Month
Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects
A lower value signifies improvement.
Front
Group
Value
95% CI
Double Treatment Arm
1.00
-312.00 – 395.50
Left Oblique
Group
Value
95% CI
Double Treatment Arm
164.50
-56.50 – 730.00
Nose
Group
Value
95% CI
Double Treatment Arm
45.50
-25.00 – 94.50
Right Oblique
Group
Value
95% CI
Double Treatment Arm
214.50
-39.50 – 789.50
Change in Porphyrins at 3 Months From Baseline (Double Treatment Group)Primary· Baseline, 3 Months
Quantitively assessment of change in overall porphyrins count using measurements provided VISIA 3D analysis on different sides of the face for all subjects
A lower value signifies improvement.
Front
Group
Value
95% CI
Double Treatment Arm
-160.50
-266.00 – -1.00
Left Oblique
Group
Value
95% CI
Double Treatment Arm
-145.50
-263.00 – 158.50
Nose
Group
Value
95% CI
Double Treatment Arm
3.00
-66.00 – 60.00
Right Oblique
Group
Value
95% CI
Double Treatment Arm
13.00
-278.50 – 135.50
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
Last refreshed: 27 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06091215.