Pigmentation
Conditions
Brief summary
The purpose of this study is to evaluate the Dermal Cooling System for lightening of benign pigmented lesions and to assess additional cosmetic benefits.
Detailed description
This is a prospective, non-randomized, open-label study to evaluate the effectiveness of the Dermal Cooling system to reduce pigmentation in benign pigmented lesions and to determine if additional cosmetic benefits are achieved.
Interventions
DEVICEDermal Cooling System
Controlled localized cooling will be applied to benign pigmented lesions using the Dermal Cooling System
Sponsors
R2 Dermatology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female subjects \> 18 years of age. 2. Subject has one or more benign pigmented lesions (e.g., solar lentigines, freckles, seborrheic keratosis), in an area suitable for treatment. 3. Subject is willing to have up to 40 treatment sites treated per treatment session depending on the size and nature of the lesions identified. 4. Subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes. 5. Subject is willing to cover treated area or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area for the duration of the study, including the follow-up period, if requested. 6. Subject has read and signed a written informed consent form. 7. Subject is willing to comply with adjuvant topical regimen, as applicable. -
Exclusion criteria
1. Physician prescribed medical or surgical treatment, or use of over-the-counter products to alter skin color, in the area of intended treatment in the previous 6 months (e.g., hydroquinone, corticosteroids, laser surgery) 2. Use of products containing glycolic acids, retinol, salicylic acid within the previous 2 weeks 3. Use of Accutane within the previous 6 months 4. Artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period 5. Scars or tattoos in the location of the treatment sites 6. History of melasma, vitiligo, eczema, or psoriasis in the area of treatment 7. History of melanoma 8. Subject is pregnant or intending to become pregnant during the study period 9. Subject is lactating or has been lactating in the past 6 months 10. Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease. 11. History of abnormal wound healing or abnormal scarring 12. Inability or unwillingness to comply with the study requirements. 13. Current enrollment in a clinical study of any other unapproved investigational drug or device. 14. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in the appearance of the treated areas as assessed by Investigator assessment. | 2-Month Follow-up visit | Investigator assessment using Global Aesthetic Improvement Scale (GAIS); graded from 4 (very much improved) to 0 (worse). |
| Safety of the treatment | Up to 12 months | Determined by incidence of device-or procedure-related adverse events |
Countries
United States
Outcome results
None listed