N/A Completed N=15 Treatment

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

Pigment Skin

Source: ClinicalTrials.gov NCT06091215 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2026

Primary outcomePrimary: Change in Brown Spots at 1 Month From Baseline (Single Treatment Group) — 12.00; 5.00; 0.00; 5.00 count of spots

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Brown Spots at 1 Month From Baseline (Single Treatment Group)	12.00; 5.00; 0.00; 5.00	—
PRIMARY Change in Brown Spots at 3 Months From Baseline (Single Treatment Group)	8.00; .00; 3.00; 9.00	—
PRIMARY Change in Brown Spots at 1 Month From Baseline (Double Treatment Group)	-2.00; -3.50; -2.00; -2.50	—
PRIMARY Change in Brown Spots at 3 Months From Baseline (Double Treatment Group)	-0.50; -4.00; -0.50; 8.50	—
PRIMARY Change in Pores at 1 Month From Baseline (Single Treatment Group)	-5.00; -5.00; -11.00; -3.00	—
PRIMARY Change in Pores at 3 Months From Baseline (Single Treatment Group)	1.00; -1.00; 1.00; -7.00	—
PRIMARY Change in Pores at 1 Month From Baseline (Double Treatment Group)	2.50; -27.50; -10.00; -17.00	—
PRIMARY Change in Pores at 3 Months From Baseline (Double Treatment Group)	-0.00; -0.00; -0.00; -0.00	—
PRIMARY Change in Porphyrins at 1 Month From Baseline (Single Treatment Group)	17.00; 51.00; 15.00; 4.00	—
PRIMARY Change in Porphyrins at 3 Months From Baseline (Single Treatment Group)	-123.00; -192.00; 32.00; -114.00	—
PRIMARY Change in Porphyrins at 1 Month From Baseline (Double Treatment Group)	1.00; 164.50; 45.50; 214.50	—
PRIMARY Change in Porphyrins at 3 Months From Baseline (Double Treatment Group)	-160.50; -145.50; 3.00; 13.00	—
PRIMARY Change in Red Features at 1 Month From Baseline (Single Treatment Group)	1.00; -7.00; -1.00; -2.00	—
PRIMARY Change in Red Features at 3 Months From Baseline (Single Treatment Group)	2.00; -7.00; 0.00; 0.00	—
PRIMARY Change in Red Features at 1 Month From Baseline (Double Treatment Group)	4.00; 7.50; 0.00; 3.50	—
PRIMARY Change in Red Features at 3 Months From Baseline (Double Treatment Group)	2.00; 5.50; 1.00; 2.50	—
PRIMARY Change in Texture at 1 Month From Baseline (Single Treatment Group)	-14.00; -3.00; -1.00; 68.00	—
PRIMARY Change in Texture at 3 Months From Baseline (Single Treatment Group)	64.00; 188.00; 30.00; 161.00	—
PRIMARY Change in Texture at 1 Month From Baseline (Double Treatment Group)	20.50; -198.00; 4.00; -225.50	—
PRIMARY Change in Texture at 3 Months From Baseline (Double Treatment Group)	-25.00; 82.00; 16.50; -72.00	—
PRIMARY Change in UV Spots at 1 Month From Baseline (Single Treatment Group)	-4.00; -4.00; 0.00; 0.00	—
PRIMARY Change in UV Spots at 3 Months From Baseline (Single Treatment Group)	-3.00; -4.00; -2.00; 1.00	—
PRIMARY Change in UV Spots at 1 Month From Baseline (Double Treatment Group)	-1.50; 5.00; -2.50; -1.00	—
PRIMARY Change in UV Spots at 3 Months From Baseline (Double Treatment Group)	-1.00; -7.50; -2.50; 4.50	—
PRIMARY Change in Visible Spots at 1 Month From Baseline (Single Treatment Group)	2.00; -3.00; -1.00; 3.00	—
PRIMARY Change in Visible Spots at 3 Months From Baseline (Single Treatment Group)	6.00; 1.00; 0.00; 3.00	—
PRIMARY Change in Visible Spots at 1 Month From Baseline (Double Treatment Group)	6.00; -6.50; -0.50; -11.00	—
PRIMARY Change in Visible Spots at 3 Months From Baseline (Double Treatment Group)	-2.00; 0.00; -0.50; -0.50	—
PRIMARY Change in Total Wrinkle Area at 1 Month From Baseline (Single Treatment Group)	-1.00; -13.00; -3.00; 5.00	—
PRIMARY Change in Total Wrinkle Area at 3 Months From Baseline (Single Treatment Group)	-1.00; -1.00; 1.00; 5.00	—
PRIMARY Change in Total Wrinkle Area at 1 Month From Baseline (Double Treatment Group)	0.50; -14.50; -2.50; -14.50	—
PRIMARY Change in Total Wrinkle Area at 3 Months From Baseline (Double Treatment Group)	0.00; 12.00; -1.00; -13.50	—

Eligibility Criteria

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:

5.1. 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

Hormonal contraception (oral, injected, implanted, patch or vaginal ring)
Barrier method with spermicide: condom or occlusive cap with spermicidal foam/gel/cream/suppository
Intrauterine device (IUD)
Surgical Sterilization (e.gh., vasectomy, tubal occlusion, hysterectomy, bilateral salpingectomy/oophorectomy)
Abstinence from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject. Periodical abstinence and withdrawal methods are not acceptable forms of contraception.
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
Individuals willing and able to cooperate with all study requirements for the duration of the study.

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:
Systemic granulomatous disease, either active or inactive, (e.g., Sarcoid, Wegener's, TB, etc) or connective tissue diseases (e.g., lupus, dermatomyositis, etc.)
Significant scars in the treatment area:
Severe or cystic and clinically significant acne or acne scars on the areas to be treated
Current or history of hypertrophic scarring or keloid scars
Tattoos in the area to be treated
Observable suntan, nevi, excessive hair, etc., or other dermal conditions that might influence study results on the face in the opinion of the Investigator
Individuals who currently have cancerous or pre-cancerous lesions in the area to be treated
Individuals with skin pathology and/or pre-existing dermatologic condition that the Investigator deems inappropriate for participation or could interfere with outcomes of the study, such as: psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, etc.
History of chronic drug or alcohol use
Recent aesthetic treatments:
<4 weeks of microdermabrasion or glycolic acid treatment to the treatment area or who plan to have this treatment during the study
<2 weeks of any type of injectable filler
<1 week of neurotoxin's
<6 months of ablative resurfacing laser treatments
<6 months of non-ablative, rejuvenative laser or light treatment
<3 months of chemical peels or dermabrasion
Use of the following prescription medications:
<6 weeks of Accutane or other systemic retinoids on the treatment area
<4 weeks of topical retinoids
<4 months of prescription strength lightening medications (e.g., hydroquinone, tretinoin, AHA, BHA, poly-hydroxy acids, 4-hydroxyanisole alone or in combination with tretinoin)
<2 weeks of anti-wrinkle or skin lightening or topical systemic medication known to affect skin aging or dyschromia (e.g., alpha/beta/polyhydroxy acids, Vitamin C, soy, Q-10; hydroquinone, etc.,), TEGO, Cosmo C250, gigawhite, lemon juice extract (topically), or embilica extract
Antiplatelet agents/anticoagulant (Coumadin, Heparin, Plavix, chronic NSAID use)
Psychiatric drugs that would impair the subject from understanding protocol requirements or understanding and signing the ICF.
Individuals who are pregnant or planning to become pregnant during the course of the study
Immunocompromised individuals or those currently using immunosuppressi

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Data sourced from ClinicalTrials.gov (NCT06091215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.