A Confirmatory Study for Evaluation of the Treatment by the Celluma3 of Periorbital Wrinkles

NCT02543970 | Completed

• 1 other identifier: RLE-001
• Study Type: observational
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to confirm the safe and effective use of the Celluma3 for the reduction in the appearance of periorbital wrinkles.

Conditions

Wrinkled Structure

Outcome Measures

Primary Outcomes (1)

• Reduction of Periorbital Wrinkles

  4 weeks of treatment and 12 week follow-up post treatment

  16 weeks

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Test subjects will be between the ages of 30-75, Type I-IV Fitzpatrick Skin Color, and willingness and ability to participate and comply with the test protocol and absence of exclusionary criteria.

You may qualify if:

• years of age
• Fitzpatrick Skin Color Type I-IV
• Clinical evidence of mild to moderate facial wrinkles as specified by the Fitzpatrick Classification of Facial Wrinkling (Perioral and Periorbital) for the degree of wrinkling and elastosis.
• Willingness and ability to comply with the protocol requirements, including returning for follow up visits and abstaining from excluded behaviors for the duration of the study.
• Willingness and ability to provide written consent for use of photographic record and adherence to photographic procedures (i.e., removal of makeup and jewelry).
• Willingness and ability to provide written informed consent prior to any study-related procedure.

You may not qualify if:

• Subject who is pregnant, nursing, or planning to become pregnant during the course of the study.
• Subjects who have any history of diabetes.
• Subjects who, in the preceding 12 months prior to the study start, have:
• Been exposed to hyaluronic acid, or
• any other filler, or
• injection for cosmetic purposes related to the face, or
• undergone any cosmetic procedure for the face, or
• had an active cut, wound or infection of the face, or
• had oral isotretinon.
• Subjects who, in the preceding six months prior to the study start, have:
• Had any botulinum toxin ("Botox"), or
• had ablative skin resurfacing on the glabellar area.
• Subjects who, in the preceding three months prior to the study start, have:
• Had retinoid, microdermabrasion or prescription level glycolic acid treatments, or
• had any compromising procedure in the opinion of any clinical evaluator.

Sponsors & Collaborators

• BioPhotas: lead

Study Officials

• Jesse Mitchell, MD, FAAD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 9, 2015
• Study Start: February 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 9, 2015

Record last verified: 2015-09