Laser 360iQ: Optimal Light-laser Combination Therapy

NCT04519723 | Completed DMC

• 1 other identifier: XYZ-12345-2012
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the safety and efficacy of light-laser combination therapy for the improvement of skin color, tone, texture and laxity

Conditions

Photodamage

Keywords

Hyperpigmentation; telangiectasias

Outcome Measures

Primary Outcomes (1)

• Visual observation of improvement in photoaging

  The investigator will evaluate the clinical improvement from the visual appearance of the treated area and from the fixed magnification clinical photographs according to the following Global Assessment scale (compared to baseline photographs): Global Aesthetic Improvement Scale (GAIS ) Rating Description 1. = Very much improved 75%-99% 2. = Much improved 50%-75% 3= Improved 25%-50% 4= No change 1%-25% 5=Worse \<1%

  The investigator will evaluate the change in visual appearance of the treated area before one month, two month, and three month treatments and before each follow-up visit (1 month and 3 months after the last treatment).

Study Arms (1)

Alma Harmony Laser System

OTHER

There is only one arm. Three hand modules; Dye-VL 500-600nm, High Power QSW 1064nm, and High power Pixel ER:YAG 2940nm laser module with rollers will be utilized in combination in a series of treatments intended to improve skin color, tone, texture and laxity. Subjects will receive up to four treatments administered in intervals of 28 +/- 2 days. Treatment duration of approximately 60 minutes.

Device: Assess the safety and efficacy of light-laser therapy using the Harmony XL and Dye-VL (500-600nm), Q-Switched 1064nm, Er:YAG 2940nm modules in combination .

Interventions

Assess the safety and efficacy of light-laser therapy using the Harmony XL and Dye-VL (500-600nm), Q-Switched 1064nm, Er:YAG 2940nm modules in combination . DEVICE

Alma Harmony Laser System

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female in good general health between 35 to 60 years of age.
• Must be willing to execute informed consent. Patient must also consent to having photos taken at each visit.
• A potential subject must exhibit:
• Facial wrinkling and graded mild to moderate overall rough texture, large pores, and/or skin laxity.
• For FEMALE PATIENTS OF CHILDBEARING POTENTIAL, must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation) and is willing to use an acceptable form of birth control during the entire course of the study \[i.e., acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplanit®, Depo-Provena®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the subject become sexually active\]. All systemic birth control measures must be in consistent use at least 30 days prior to study participation.
• Negative urine pregnancy test results at the time of study entry (if applicable).
• Must be willing to comply with study visits and complete the entire course of the study.

You may not qualify if:

• Negative urine pregnancy test results at the time of study entry (if applicable).
• Must be willing to comply with study visits and complete the entire course of the study.
• Subjects meeting any of the following criteria will be excluded from participation:
• A subject with any UNCONTROLLED systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
• A subject with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
• A subject using any topical product containing a retinoid, retinol, or other vitamin A derivative within 3 months prior to or during the study period.
• A subject using any systemic steroid therapy within 6 months prior to or during the study period.
• A subject that has been treated with Botox/Dysport or filler/biostimulatory molecule injections to his/her face within the past six months.
• A subject using any topical medicated creams, lotions, powders, etc. on the treatment areas during the study period, other than the study treatment regimen within 14 days.
• A subject that has previously been treated with systemic retinoids within the past year (e.g., Accutane®, Roche Dermatologics).
• A subject with recently excessive facial exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing). During the study, when excessive sun exposure is unavoidable, subjects must wear appropriate protective clothing (e.g. hat) and comply with the study dosing regimen of daily application of the dispersed sunblock.
• A subject with a recent history or active presence of any facial skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e. moderate to severe acne vulgaris, atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis, excessive facial hair or coloration).
• A female subject who is pregnant, nursing an infant or planning a pregnancy during the study \[throughout the course of the study, women of child-bearing potential must use reliable forms of contraception (i.e., oral contraceptive, intrauterine device, abstinence, or spermicides and condoms used in combination)\].
• Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
• Subjects who are pregnant, breast-feeding, or planning a pregnancy. Females of childbearing potential, in addition to having a negative pregnancy test at the screening visit, must be either:

Sponsors & Collaborators

• Alma Lasers Inc.: lead

Study Sites (1)

Zel Skin & Laser Specialist

Edina, Minnesota, 55424, United States

Location

MeSH Terms

Conditions

Hyperpigmentation; Telangiectasis

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Brian Zelickson, MD

  Board Certified Dermatologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: August 20, 2020
• Study Start: February 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 20, 2020

Record last verified: 2012-04

Locations

US (1)