Fractionated 1927nm Laser for Diffuse Pigmentation and Actinic Changes.

NCT05226104 | Completed Results FDA Device

• 1 other identifier: STU-2021-1191
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Pigment

Outcome Measures

Primary Outcomes (6)

• Change in Dyspigmentation Spots

  Numeric analysis of dyspigmentation (spots) will be analyzed using VISIA System. The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.

  Baseline, Month 1 and Month 3

• Change in UV Spots

  Numeric analysis of lesions resulting from photodamage will be analyzed using VISIA System. The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.

  Baseline, Month 1 and Month 3

• Change in Brown Spots

  Numeric analysis of lentigines and melasma will be analyzed using the VISIA system. The change from baseline was calculated at Month 1 and Month 3. An increase in the absolute count would indicate improvement.

  Baseline, Month 1 and Month 3

• Physician's Global Assessment Scores (PGAS)- Right Face

  Clinician evaluators assessed the right side of each participants 1 and 3 month photographs to subjectively score clinical improvement. PGAS Score Description 0 Clear, except for possible residual discoloration, 100% improvement. 1. Almost clear, very significant clearance, 90% improvement; only minor evidence of hyperpigmentation remains. 2. Marked improvement, significant improvement, 75% improvement. Some disease evidence of hyperpigmentation remains. 3. Moderate improvement, intermediate between slight and marked improvement; 50% improvement in appearance of hyperpigmentation 4. Slight improvement, some improvement, 25% improvement; significant evidence of hyperpigmentation remains 5. No improvement; hyperpigmented condition unchanged 6. Worse; condition worse than at week 0

  Month 1 and Month 3

• Physician's Global Assessment Scores (PGAS)- Left Face

  Clinician evaluators assessed the left side of each participants 1 and 3 month photographs to subjectively score clinical improvement. PGAS Score Description 0 Clear, except for possible residual discoloration, 100% improvement. 1. Almost clear, very significant clearance, 90% improvement; only minor evidence of hyperpigmentation remains. 2. Marked improvement, significant improvement, 75% improvement. Some disease evidence of hyperpigmentation remains. 3. Moderate improvement, intermediate between slight and marked improvement; 50% improvement in appearance of hyperpigmentation 4. Slight improvement, some improvement, 25% improvement; significant evidence of hyperpigmentation remains 5. No improvement; hyperpigmented condition unchanged 6. Worse; condition worse than at week 0

  Month 1 and Month 3

• Physician's Global Assessment Score (PGAS)- Overall

  Clinician evaluators assessed 1 and 3 month photographs to subjectively score clinical overall improvement. PGAS Score Description 0 Clear, except for possible residual discoloration, 100% improvement. 1. Almost clear, very significant clearance, 90% improvement; only minor evidence of hyperpigmentation remains. 2. Marked improvement, significant improvement, 75% improvement. Some disease evidence of hyperpigmentation remains. 3. Moderate improvement, intermediate between slight and marked improvement; 50% improvement in appearance of hyperpigmentation 4. Slight improvement, some improvement, 25% improvement; significant evidence of hyperpigmentation remains 5. No improvement; hyperpigmented condition unchanged 6. Worse; condition worse than at week 0

  Month 1 and Month 3

Study Arms (1)

Healthy Participants

OTHER

Subjects who are interested in treatment for facial fine lines and wrinkles will be recruited for the study.

Device: MOXI

Interventions

MOXI DEVICE

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.

Healthy Participants

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Department of Plastic Surgery

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Pigmentation Disorders

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Research Coordinator
• Organization: UT Southwestern

jennifer.barillas@utsouthwestern.edu

214-645-8907

Study Officials

• Abby Culver, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

• Jeffrey Kenkel, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 7, 2022
• Study Start: May 18, 2022
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: August 21, 2023
• Results First Posted: August 21, 2023

Record last verified: 2023-07

Locations

US (1)