ClinicalTrials.gg
Status unknownNCT02818556Updated Jun 29, 2016

A Clinical Study Comparing Restylane® Silk and Belotero Balance® for the Treatment of Superficial, Vertical Perioral Lines

A Phase 4 interventional study of Restalyne Silk and Belotero Balance in Perioral Rhytids, sponsored by The Maas Clinic. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-29.

Sponsored by The Maas Clinic · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This will be a single-center, randomized, evaluator-blinded, split-face clinical study design. Fifty patients will receive one treatment session consisting of Restylane® Silk (right side of the face) and Belotero Balance® (left side), or vice versa (1:1 dose conversion ratio) injections to the superficial, vertical perioral lines. Injections will be performed at the baseline visit. To ensure subject and investigator blinding, syringes will be prepared and labeled "1" and "2" immediately before subject attendance for injection by the sub-investigator. The same injection sites and techniques will be used on both sides of the face. Then, patients will follow-up on post-treatment day 7, 14, 30, 60, 90, 120, 150, 180.

02

Conditions studied

  • Perioral Rhytids
03

In context

Lead sponsor

The Maas Clinic is the lead sponsor of 4 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients exhibiting moderate [2] to severe [3] superficial, vertical perioral lines on the 5-point Merz® validated scale for assessment of superficial perioral lines
  • Females and males in good general health over the age of 18 years old

Must be willing to give and sign a HIPAA form, informed consent form and a photographic release form

  • Patient is planning to undergo Restylane® Silk and Belotero Balance® injections
  • For female patient of childbearing potential, must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation) and is willing to use an acceptable form of birth control during the entire course of the study [i.e., acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplanit®, Depo-Provena®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the patient become sexually active]. All systemic birth control measures must be in consistent use at least 30 days prior to study participation
  • Negative urine pregnancy test results at the time of study entry (if applicable)
  • Must be willing to comply with study regimen and complete the entire course of the study.

Exclusion criteria

Exclusion Criteria:

  • A patient with any uncontrolled systemic disease. A potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study

A patient with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.

  • A patient with a known hypersensitivity to any of the components of the study medications
  • A patient who is actively smoking or plans to smoke at any time of the duration of this study
  • A patient with an active skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis, herpes labialis)
  • A patient planning any other cosmetic procedure to their facial area during the study period, other than the treatments that will be performed by the investigator
  • A patient using any topical (prescription or over the counter) medicated creams, lotions, gels, balms, powders, etc. on the treatment areas during the study period
  • A patient receiving any topical products containing alpha-hydroxy acids, salicylic acid, and vitamins C or D (includes derivatives thereof) on the perioral areas within 7 days prior to or during the study period, other than the study products
  • A patient receiving any investigational drug and/or has had a microdermabrasion (light or medium skin peel) treatment on their perioral areas within 30 days prior to or during the study period
  • A patient using any topical tretinoin product or derivative on their perioral areas within 12 weeks prior to or during the study period
  • A patient receiving a chemical peel, any systemic steroids, a non-ablative laser, light or radio frequency treatment and/or has had a dermabrasion (deep skin peel) or ablative laser treatments on their perioral areas must have discontinued the drug/treatment and/or had the procedure at least 6 months prior to entering the study
  • A patient that has previously been treated with botulinum toxin in the perioral areas within the past six months
  • A patient that has previously been treated with dermal filler in the perioral areas within the past year
  • A patient that with a history of allergic reaction to a dermal filler or lidocaine
  • A patient that with a history of a permanent filler to the perioral areas
  • A female patient who is pregnant, nursing an infant or planning a pregnancy during the study [throughout the course of the study, women of child-bearing potential must use reliable forms of contraception (i.e., oral contraceptive, intrauterine device, abstinence, or spermicides and condoms used in combination)]
  • Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Other
    Restylane Right, Belotero Left

    Patients will receive one treatment with Restylane® Silk (right side of the face) and one treatment of Belotero Balance® (left side)

    Drug: Restalyne Silk · Drug: Belotero Balance

  • Other
    Restylane Left, Belotero Right

    Patients will receive one treatment with Restylane® Silk (left side of the face) and one treatment of Belotero Balance® (right side)

    Drug: Restalyne Silk · Drug: Belotero Balance

Interventions

  • DrugRestalyne Silk
  • DrugBelotero Balance
06

What researchers measure

Primary outcomes

  1. Change in Response to therapy as evaluated by investigator using 5-point Merz® Scale

    Response to therapy on each side of the lip on day 0 (initial treatment), and subsequent post-treatment days 7, 14, 30, 60, 90, 120, 150, 180, as measured by the blinded evaluator: A 1-point improvement from baseline in superficial, vertical, perioral rhytids based on the 5-point Merz® Scale

    Time frame: Day 0, 7, 14, 30, 60, 90, 120, 150, 180

Secondary outcomes

  1. Response to Therapy- Subject

    Response to therapy on each side of the lip on day 0 (initial treatment), and subsequent post-treatment days 7, 14, 30, 60, 90, 120, 150, 180, as measured by the blinded patient: A 20% improvement from baseline in superficial, vertical, perioral rhytids using a linear analog scale

    Time frame: Day 0, 7, 14, 30, 60, 90, 120, 150, 180

  2. Severity grading- Evaluator

    Severity grading by a blinded evaluator employing standardized photography in combination with the 5-point Merz® Scale

    Time frame: 6 months

  3. VISIA complexion analysis

    VISIA complexion analysis (Canfield Imaging Systems, Fairfield, New Jersey) on day 0 (initial treatment), day 30 and when the patient's perioral fine lines have returned to baseline. VISIA analysis will be used to grade the patient's skin by measuring the wrinkles and generating a percentile score.

    Time frame: Day 0, Day 30

07

Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02818556
Lead sponsor
The Maas Clinic
Responsible party
Corey S. Maas, M.D. (Principal Investigator, The Maas Clinic) — Principal investigator
First posted
Jun 29, 2016
Start date
Jun 2016
Primary completion
Jan 2017 (estimated)
Last update
Jun 29, 2016

Study contacts

Rachel Bass
Contact
research@maasclinic.com
(415)567-8275
Kyle Jennings
Contact
research2@maasclinic.com
(415)567-7000
Corey S. Maas, M.D.
principal investigator · The Maas Clinic
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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