Melasma
Conditions
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.
Interventions
DEVICEPiQo4
PiQo4 Laser System for treatment of Melasma
Sponsors
Focus Medical, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Face sides will be randomized to receive either 1064nm alone or 1064nm & 585nm combination treatment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Female 2. Age= 18-75. 3. Fitzpatrick skin phototype = II-V 4. Melasma severity: diagnosed with mild to severe melasma lesions (MSS≥2) 5. Melasma type: Dermal or mixed type melasma, confirmed by Wood's lamp test 6. Melasma duration: The subject's melasma has persisted for greater than 6 months 7. Melasma previous treatments: has failed to respond to conventional treatment with hydroquinone or other topical lightening agents 8. Able to read, understand and provide written Informed Consent. 9. Able and willing to comply with the treatment/follow-up schedule and post treatment care 10. Agreed to use the same facial skin care products during the clinical trial period (including the follow-up period) 11. 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 12. 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 13. 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 14. (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. 15. Agreed not to undergo any other procedure on their face during their participation in the clinical trial
Exclusion criteria
1. Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 3 months after completion of breastfeeding 2. Known hypersensitivity or contraindications to anaesthetic agents including lidocaine and its derivatives 3. Participation in a study of another device or drug within three months prior to enrolment or during the study. 4. Presence of open wounds or lesions in the area 5. Extensive scarring or tattoos in areas to be treated. 6. Having other pigmentation disorder 7. Having an excessive underlying vascular condition (e.g. dense network of capillaries). 8. 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. 9. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study. 10. 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 11. Subjects who are opposed to possible damage to the hair follicles with possible loss of hair in the treatment area 12. 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. 13. IPL or superficial chemical peel within the previous 1 month 14. Topical therapy with retinoids, imiquimod, 5-fluorouracil, ingenol mebutate, diclofenac, alpha-hydroxy acids, or salicylic acids within the previous 1 month. 15. 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 16. Lightening oral medication (hydroquinone, tranexamic acid), isotretinoid (or retinoid), light-sensitive medication, or steroids in the last 6 months 17. History of keloid scarring, hypertrophic scarring, or of abnormal wound healing. 18. History of connective tissue diseases such as systemic lupus erythematosus or scleroderma 19. Active leukoplakia, eczema, or psoriasis in the treatment area 20. History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation. 21. History of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis. 22. Has used photosensitizing drugs (e.g., Declomycin, sulfa antibiotics, phenothiazines, etc.) within a timeframe where photosensitization from these drugs may still be present 23. History of skin cancer in the treatment area 24. Significant concurrent illness or any disease state that in the opinion of the Investigator would interfere with the treatment or healing process 25. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications. 26. Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician's discretion). 27. History of hormonal therapy in the last 3 months (e.g., estrogen, progesterone, or oral contraceptive) 28. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 1 month follow up | The study will be deemed successful if the point estimate of the percent of successful subjects will be at least 50%. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed