Efficacy and Safety of PiQo4 Device for Treatment of Melasma

NCT03565341 | Completed FDA Device

• 1 other identifier: Focus-PiQo4 Melasma-17-04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Single center, Prospective, Open Label with Split-face Study Design. Face sides will be randomized to receive either 1064nm alone or 1064nm \& 585nm combination treatment. Each subject will receive up to 3 treatments at monthly intervals (±4 days). Follow-up visits will take place at 1, 3, and 6 months following the last treatment.

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• Percent of subjects having an improvement of at least 1 point on the MSS or ≥ 50% MASI score improvement on at least one of the face sides at the 1-month follow-up visit.

  The study will be deemed successful if the point estimate of the percent of successful subjects will be at least 50%.

  1 month follow up

Secondary Outcomes (2)

• Percent of subjects having an improvement of at least 1 point on the MSS or ≥ 50% MASI score improvement on at least one of the face sides at the 3-month follow-up visit

  3 months follow up

• Percent of subjects having an improvement of at least 1 point on the MSS or ≥ 50% MASI score improvement on each face side

  6 months follow up

Study Arms (1)

Melasma

EXPERIMENTAL

Treatment of Melasma Using PiQo4 Laser System

Device: PiQo4

Interventions

PiQo4 DEVICE

PiQo4 Laser System for treatment of Melasma

Melasma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Female
• Age= 18-75.
• Fitzpatrick skin phototype = II-V
• Melasma severity: diagnosed with mild to severe melasma lesions (MSS≥2)
• Melasma type: Dermal or mixed type melasma, confirmed by Wood's lamp test
• Melasma duration: The subject's melasma has persisted for greater than 6 months
• Melasma previous treatments: has failed to respond to conventional treatment with hydroquinone or other topical lightening agents
• Able to read, understand and provide written Informed Consent.
• Able and willing to comply with the treatment/follow-up schedule and post treatment care
• Agreed to use the same facial skin care products during the clinical trial period (including the follow-up period)
• Agreed to the prohibition of the use of local/systemic corticosteroids or retinoids and other local/systemic lightening medications, and willing to abide by such instructions
• Agreed to the daily use of an over SPF 50 sunblock on their face during the clinical trial period (including the follow-up period), and willing to abide by such instructions
• Agreed to have their face photographed and willingness to allow Focus Medical (the study Sponsor) and Lumenis and the investigators to use de-identified photographs of the treated area for presentation and publication purposes
• (In case of fertile women) Tested negative in the pregnancy test and agreed to use birth control contraceptives during the clinical trial period - Oral contraceptives are forbidden as they may influence the results of the clinical study.
• Agreed not to undergo any other procedure on their face during their participation in the clinical trial

You may not qualify if:

• Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 3 months after completion of breastfeeding
• Known hypersensitivity or contraindications to anaesthetic agents including lidocaine and its derivatives
• Participation in a study of another device or drug within three months prior to enrolment or during the study.
• Presence of open wounds or lesions in the area
• Extensive scarring or tattoos in areas to be treated.
• Having other pigmentation disorder
• Having an excessive underlying vascular condition (e.g. dense network of capillaries).
• Suffering from current or history of significant skin conditions in the treated area that could interfere with the evaluation (i.e. infection, dermatitis, or rash on their face) or requires the use of interfering topical or systemic therapy.
• Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
• Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen
• Subjects who are opposed to possible damage to the hair follicles with possible loss of hair in the treatment area
• Laser or medium/deep chemical peel, or surgery, or filler treatments using collagen, hyaluronic acid, or any other material at area of treatment, within 6 months of initial treatment or during the course of the study.
• IPL or superficial chemical peel within the previous 1 month
• Topical therapy with retinoids, imiquimod, 5-fluorouracil, ingenol mebutate, diclofenac, alpha-hydroxy acids, or salicylic acids within the previous 1 month.
• Currently using topical retinoid, hydroquinone or corticosteroid or whitening cream such as alpha arbutin, azelaic acid, kojic acid ascorbic acid or any cosmetics within 2 weeks

Sponsors & Collaborators

• Focus Medical, LLC: lead

Study Sites (1)

Hackensack University Medical Center - Skin Laser & Surgery Specialists Of NY & NJ

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David J Goldberg, MD

  Hackensack University Medical Center - Skin Laser & Surgery Specialists Of NY & NJ

  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

Model Details: Face sides will be randomized to receive either 1064nm alone or 1064nm \& 585nm combination treatment

Study Record Dates

• First Submitted: June 10, 2018
• First Posted: June 21, 2018
• Study Start: July 2, 2018
• Primary Completion: August 8, 2019
• Study Completion: August 8, 2019
• Last Updated: December 27, 2019

Record last verified: 2019-02

Locations

US (1)