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

The purpose of this study is to evaluate the Dermal Cooling System for lightening of benign pigmented lesions and to assess additional cosmetic benefits.

Study Overview

• Status: Completed
• Conditions: Pigmentation
• Intervention / Treatment: Device: Dermal Cooling System

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.

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alejandro Arnez; Phone Number: 925 329-6333; Email: Alejandro.arnez@sculptology.com
• Study Contact Backup: Name: Andre Bonnett, MD; Phone Number: 925 329-6333; Email: Andre.bonnett@sculptology.com

Study Locations

• United States
  • California
    • Pleasanton, California, United States, 94566
      • Sculptology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with Dermal Cooling System; Dermal Cooling System will be used in all eligible subjects.	Device: Dermal Cooling System; Controlled localized cooling will be applied to benign pigmented lesions using the Dermal Cooling System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: R2 Dermatology
• Investigators: Principal Investigator: Andre Bonnett, MD, Sculptology

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: July 26, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: R2-20-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No