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CompletedNCT02543970Updated Sep 9, 2015

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

An observational study in Wrinkled Structure, sponsored by BioPhotas. Completed. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-09.

Sponsored by BioPhotas · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
42
Ages
30 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

This clinical study is an open label investigation into the use of the Celluma3 for the effective treatment of periorbital wrinkles.

Test subjects will visit a study center for thirty minute treatments, three times per week, for a period of four weeks, and a twelve week post-treatment follow up after the final treatment. Test subjects will have photos taken at the start, at the end of the four week treatment, and at the final twelve week post-treatment follow up visit.

One of the three Clinical Investigators, will act as the Principal Investigator and all three Clinical Investigators will evaluate the test subjects for inclusion and final results. The Clinical Research Associate (CRA) will monitor the study for conformance to the test protocol.

There will be seven estheticians participating in the study and there will be fifty test subjects recruited.

02

Conditions studied

  • Wrinkled Structure
03

In context

Lead sponsor

This is the only study on the registry with BioPhotas as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

  1. 30-75 years of age
  2. Fitzpatrick Skin Color Type I-IV
  3. 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.
  4. 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.
  5. Willingness and ability to provide written consent for use of photographic record and adherence to photographic procedures (i.e., removal of makeup and jewelry).
  6. Willingness and ability to provide written informed consent prior to any study-related procedure.
  7. Absence of any of the exclusionary criteria

Exclusion criteria

Exclusion Criteria:

  1. Subject who is pregnant, nursing, or planning to become pregnant during the course of the study.
  2. Subjects who have any history of diabetes.

  3. Subjects who, in the preceding 12 months prior to the study start, have:

    1. Been exposed to hyaluronic acid, or
    2. any other filler, or
    3. injection for cosmetic purposes related to the face, or
    4. undergone any cosmetic procedure for the face, or
    5. had an active cut, wound or infection of the face, or
    6. had oral isotretinon.

  4. Subjects who, in the preceding six months prior to the study start, have:

    1. Had any botulinum toxin ("Botox"), or
    2. had ablative skin resurfacing on the glabellar area.

  5. Subjects who, in the preceding three months prior to the study start, have:

    1. Had retinoid, microdermabrasion or prescription level glycolic acid treatments, or
    2. had any compromising procedure in the opinion of any clinical evaluator.
  6. Any other diagnosis of any contraindication in the current User Manual.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
42 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Reduction of Periorbital Wrinkles

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

    Time frame: 16 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02543970
Lead sponsor
BioPhotas
Responsible party
Sponsor
First posted
Sep 9, 2015
Start date
Feb 2015
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Sep 9, 2015

Study contacts

Jesse Mitchell, MD, FAAD
principal investigator

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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