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N/A N=27 Treatment

Fractionated 1927nm Laser for Diffuse Pigmentation and Actinic Changes.

Skin Pigment

Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Change in Dyspigmentation Spots — 48.3; 46; 42.2; 42.5 Dyspigmentation Spots

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
MOXI (Device)
Age
Adult · 20+ yrs
Sex
All
Sponsor
University of Texas Southwestern Medical Center
Primary completion
Sep 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Dyspigmentation Spots
48.3; 46; 42.2; 42.5; 46.1; 42.9
PRIMARY
Change in UV Spots
29.4; 25.4; 22.4; 21.6; 25.8; 24.3
PRIMARY
Change in Brown Spots
62.5; 60.3; 56.3; 57.1; 59.1; 58.6
PRIMARY
Physician's Global Assessment Scores (PGAS)- Right Face
3.45; 3.60
PRIMARY
Physician's Global Assessment Scores (PGAS)- Left Face
3.44; 3.72
PRIMARY
Physician's Global Assessment Score (PGAS)- Overall
3.44; 3.66

Summary

This is a single-site, non-randomized, non-controlled study at UT Southwestern Medical Center at Dallas in the Department of Plastic Surgery designed to follow up to 30 qualified and consenting subjects receiving a fractionated 1927 combination treatments for diffuse hyperpigmentation and/or melasma. Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months, followed by two follow-up visits at 1-month and 3-months post-treatment.

Eligibility Criteria

Inclusion Criteria

  • Healthy male and female adults between 20-60 years of age.
  • Fitzpatrick skin type I-IV.
  • Individuals deemed by the Investigator to have a significant amount of pigmentation/melasma and that desire correction of this condition.
  • Individuals willing to withhold aesthetic therapies, or other therapies judged to potentially impact results to the treatment areas for the duration of the study.
  • Women of childbearing potential who agree to take a urine pregnancy test at the Screening visit or when deemed by Investigator. Women of childbearing potential must have a negative urine pregnancy test and must not be lactating at Screening. Women must be willing and able to use an acceptable method of birth control (see below) during the study. Women will not be considered of childbearing potential if one of the following is documented - postmenopausal for at least 12 months prior to study, without a uterus and/or both ovaries, bilateral tubal ligation at least 6 months prior to study enrollment
  • Individuals of childbearing potential who use an acceptable method of contraception throughout the study. Acceptable methods of birth control include:
  • Established use of hormonal contraception (oral, injected, implanted, patch or vaginal ring)
  • Barrier methods with spermicide: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
  • Intrauterine device (IUD) or intrauterine system (IUS)
  • Surgical sterilization (e.g. vasectomy confirmed to be effective by sperm count check, tubal occlusion, hysterectomy, bilateral salpingectomy/oophorectomy)
  • Abstinence from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) 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.
  • 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 lidocaine or ester-based local anesthetics.
  • Active systemic or local conditions that may affect wound healing.
  • Current or recent history of inflammatory skin disease, infection or unhealed wound in the proposed treatment area(s).
  • History of systemic granulomatous diseases, either active or inactive, (e.g. Sarcoid, Wegener's, TB, etc.) or connective tissue diseases (e.g. lupus, dermatomyosistis, etc.).
  • Recent history of significant trauma to the areas to be treated (< 6 months).
  • Significant scarring, other than acne scars, in the area(s) to be treated.
  • Current or history of hypertrophic scarring or keloid scars.
  • Severe or cystic and clinically significant acne on the area(s) to be treated.
  • Tattoos in the area to be treated.
  • Observable suntan, nevi, excessive hair, etc. or other dermal conditions on the treatment area(s) of the face that might influence study results in the opinion of the Investigator.
  • Individuals who currently have cancerous or pre-cancerous lesions in the area(s) to be treated and/or with a history of skin cancer.
  • Individuals with skin pathology and/or pre-existing dermatologic condition in the treatment area (i.e. psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, hyper or hypo-skin pigmentation conditions such as post inflammatory hyperpigmentation) that the Investigator deems inappropriate for participation or could interfere with outcomes of the study.
  • History of chronic drug or alcohol use.
  • Microdermabrasion or glycolic acid treatment to the treatment area(s) within 4 weeks of study participation or who plan on having this treatment during the study.
  • History of the following
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05226104). 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.

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