NCT02551562

Brief Summary

20 female subjects, between the ages of 25 and 60, who request a full facial rejuvenation treatment, meet all the inclusion and none of the exclusion criteria, and have signed a written informed consent, will be enrolled. Subjects will be divided randomly into two treatment groups:

  1. 1.Group A: subjects will use a basic skin care regime following a full facial rejuvenation with hyaluronic acid soft-tissue filler and botulinum neurotoxin.
  2. 2.Group B: subjects will use the Nu-Derm® system following a full facial rejuvenation with hyaluronic acid soft-tissue filler and botulinum neurotoxin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

October 6, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2016

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

September 14, 2015

Last Update Submit

February 6, 2019

Conditions

Subjects Requesting and Requiring Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid Fillers

Outcome Measures

Primary Outcomes (1)

  • Overall aesthetic improvements

    The primary objective of this study is to examine the effect of skin rejuvenation therapy in combination with full facial rejuvenation, via neurotoxin or HA soft-tissue filler, on the overall aesthetic improvements.

    90 Days

Secondary Outcomes (1)

  • State Self-Esteem

    90 Days

Study Arms (2)

Group A: Basic Skin Care

PLACEBO COMPARATOR

Subjects will use a basic skin care regime following a full facial rejuvenation with hyaluronic acid soft-tissue filler and botulinum neurotoxin.

Other: Placebo

Group B: NuDerm® System

EXPERIMENTAL

Subjects will use the Nu-Derm® system following a full facial rejuvenation with hyaluronic acid soft-tissue filler and botulinum neurotoxin.

Other: NuDerm® System

Interventions

NuDerm® SystemOTHER

The Nu-Derm® System (Valeant Pharmaceuticals North America, LLP) is a skin care system that helps correct and reduce visible signs of aging such as age spots, rough skin, erythema, sallowness, and hyperpigmentation.

Group B: NuDerm® System
PlaceboOTHER

Basic skin care regimen

Group A: Basic Skin Care

Eligibility Criteria

Age25 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject requires a full facial rejuvenation with a HA soft tissue filler and/or botulinum neurotoxin, per judgment of the PI;
  • Subject is willing and able to provide written informed consent prior to the performance of any study related procedure;
  • Subject is willing and able to comply with the protocol requirements; and
  • Subject is willing and able to provide written photo consent and adhere to the photography and video procedures such as removal of jewelry and makeup.

You may not qualify if:

  • Subjects who have received any facial filler or neurotoxin treatments in the 12-month period prior to enrollment;
  • Previous treatment with any facial aesthetic procedure (e.g. chemical peeling, photo rejuvenation, and laser treatments) within the 12-month period prior to enrollment;
  • Subjects who plan to undergo facial cosmetic surgery or any aesthetic procedure (e.g. neurotoxins, dermal fillers, laser treatments, and chemical peels), which are not specified in this protocol, during the course of the study;
  • A known allergy or sensitivity to any component of the study ingredients;
  • Use of systemic steroids or anticoagulation medications;
  • Subjects with a history of bleeding disorders;
  • Subjects with severe allergies manifested by a history of anaphylaxis or presence of multiple severe allergies;
  • Subjects with hypersensitivity to botulinum neurotoxin;
  • Subject with allergies to gram positive bacterial proteins;
  • Sensitivity to sulfides;
  • Subjects with allergy to cow's milk protein;
  • Subjects with previous history of sensitivity to amide type local anesthetics;
  • Subject with surgical alterations to the facial anatomy or marked facial asymmetry;
  • Inflammation or infection at the injection site(s);
  • Subjects with a history of eyelid or eyebrow ptosis;
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DeNova research

Chicago, Illinois, 60611, United States

Location

Study Officials

  • Steven H Dayan, MD

    DeNova Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2015

First Posted

September 16, 2015

Study Start

October 6, 2015

Primary Completion

September 9, 2016

Study Completion

September 9, 2016

Last Updated

February 8, 2019

Record last verified: 2019-02

Locations

US(1)