Evaluation of the Dermal Cooling System for the Enhanced Treatment of Benign Pigmented Lesions and Common Skin Conditions

NCT04493021 | Completed FDA Device

• 1 other identifier: R2-20-001
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Pigmentation

Outcome Measures

Primary Outcomes (2)

• 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

• Safety of the treatment

  Determined by incidence of device-or procedure-related adverse events

  Up to 12 months

Study Arms (1)

Treatment with Dermal Cooling System

EXPERIMENTAL

Dermal Cooling System will be used in all eligible subjects.

Device: Dermal Cooling System

Interventions

Dermal Cooling System DEVICE

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

Treatment with Dermal Cooling System

Eligibility Criteria

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

You may qualify if:

• Male or female subjects \> 18 years of age.
• Subject has one or more benign pigmented lesions (e.g., solar lentigines, freckles, seborrheic keratosis), in an area suitable for treatment.
• Subject is willing to have up to 40 treatment sites treated per treatment session depending on the size and nature of the lesions identified.
• Subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes.
• 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.
• Subject has read and signed a written informed consent form.
• Subject is willing to comply with adjuvant topical regimen, as applicable. -

You may not qualify if:

• 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)
• Use of products containing glycolic acids, retinol, salicylic acid within the previous 2 weeks
• Use of Accutane within the previous 6 months
• 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
• Scars or tattoos in the location of the treatment sites
• History of melasma, vitiligo, eczema, or psoriasis in the area of treatment
• History of melanoma
• Subject is pregnant or intending to become pregnant during the study period
• Subject is lactating or has been lactating in the past 6 months
• Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease.
• History of abnormal wound healing or abnormal scarring
• Inability or unwillingness to comply with the study requirements.
• Current enrollment in a clinical study of any other unapproved investigational drug or device.
• 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.

Sponsors & Collaborators

• R2 Dermatology: lead

Study Sites (1)

Sculptology

Pleasanton, California, 94566, United States

Location

Study Officials

• Andre Bonnett, MD

  Sculptology

  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: July 26, 2020
• First Posted: July 30, 2020
• Study Start: July 7, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

US (1)