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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04493021
Other study ID # R2-20-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 7, 2020
Est. completion date May 31, 2022

Study information

Verified date August 2023
Source R2 Dermatology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 137
Est. completion date May 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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. -

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Dermal Cooling System
Controlled localized cooling will be applied to benign pigmented lesions using the Dermal Cooling System

Locations

Country Name City State
United States Sculptology Pleasanton California

Sponsors (1)

Lead Sponsor Collaborator
R2 Dermatology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in the appearance of the treated areas as assessed by Investigator assessment. Investigator assessment using Global Aesthetic Improvement Scale (GAIS); graded from "4" (very much improved") to "0" (worse). 2-Month Follow-up visit
Primary Safety of the treatment Determined by incidence of device-or procedure-related adverse events Up to 12 months
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