Wrinkles

About Wrinkles Clinical Trials (Click to Open)

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Wrinkles

General Purpose:

Skin wrinkles naturally occur as part of the aging process, however, they tend to be most prominent on areas of skin that have received increased sun exposure over time. Such areas include the face, neck, hands, and forearms. They can also be caused by smoking, repetitive facial expressions, and malnutrition.

Due to their prominence in some of the body’s most outwardly-visible areas, many individuals seek out ways to decrease the appearance of their wrinkles, or even eliminate them altogether. Today there are a number of therapies available for such purposes, including medications, skin resurfacing procedures, injections, and surgery.

As graceful aging gains popularity and more people turn to medicinal or surgical interventions to slow the progression of their wrinkles, researchers are hard at work refining existing treatments and drugs, as well as searching for new and better methods of improving the appearance of wrinkles and fine lines 

What Will A Clinical Trial For Wrinkles Be Like?

The types of procedures used in wrinkle-related clinical trials will ultimately depend on the specific nature of the study and what type of treatment is being studied. Provided below is a list of common procedures, tests, and assessments that may be incorporated into such clinical trials:

  • Detailed physical examination
  • Photographs of your wrinkles to document before-and-after progress of treatment
  • Topical prescription medications that contain derivatives of vitamin A
  • Non-prescription anti-wrinkle creams
  • Surgical procedures such as a face-lift, in which the excess skin and fat in the lower face is removed and the underlying muscles and connective tissues are tightened.
  • Skin resurfacing techniques such as the following:
    • Dermabrasion: a procedure by which the top layer of skin is “sanded-down” by a brush that rotates rapidly, causing a new top layer of skin to re-grow.
    • Microdermabrasion: a procedure similar to dermabrasion, but involves the use of vacuum suction and targeted blasting with aluminum oxide crystals.
    • Laser and radiofrequency treatments: these methods also remove the top layer of skin, but also heat the underlying skin in order to promote the growth of collagen.
    • Chemical peels: a procedure by which a mild acid is applied to affected areas. The acid burns the outer layer of the skin, which is eventually replaced by a new layer.
    • Botox (botulinum toxin type A): this procedure involves the use of injecting tiny amounts of botulism toxin into specific muscles, which prevents the muscles from contracting. This leads to flatter and smoother-appearing skin.
    • Soft tissue fillers: these techniques involve the injection of fat, collagen and mild acids into deep wrinkles, which plumps the skin and gives it more volume.
    • You may be asked to complete a questionnaire to determine how much of an impact your wrinkles have on your emotional-well being, self-confidence, and self-esteem.
    • Dietary interventions
    • Smoking cessation interventions
    • Vitamin supplements

Typical Wrinkle-Related Clinical Trial Protocol:

Specific examples of clinical trials for wrinkles might include the following:

  • A randomized clinical trial in which smokers with significant neck wrinkles are randomized to receive a newly-developed biological drug or a placebo, to determine if the new drug is able to decrease the appearance of neck wrinkles in smokers when used daily for a three month period. In such a study, before and after photos would be taken and evaluated by study physicians to objectively document the efficacy of the drug.
  • A clinical trial to determine if using a vitamin A-derived facial cream following dermabrasion is more effective at improving the look of wrinkles than simple dermabrasion alone in women over the age of 50 with moderate to severe facial wrinkles.
  • A study to determine the safety and efficacy of using Botox to treat facial-expression related wrinkles around the corners of the mouth and eyes.
  • A study designed to evaluate the utility of a newly-developed tool for grading and rating the appearance of wrinkles and uneven skin color.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know as many details as possible with regard to your specific circumstances when searching for clinical trials.  Examples of information you may want to have on hand include the following:

  • Your prior and current diagnoses of any other health conditions or diseases
  • Your current medications (including vitamins, minerals, and other dietary supplements)

Suggested Search Terms:

 “wrinkle treatment,” “wrinkle prevention,” “wrinkle surgery,” “skin resurfacing,” “wrinkles vitamins,” “wrinkles sun exposure,” “wrinkles smoking,” “eye wrinkles,” “face wrinkles,” and “neck wrinkles.”

Current Search Term:

“Wrinkles”

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Comparison of the Cosmetic Effects of Bakuchiol and Retinol


Conditions:   Wrinkle;   Photoaging
Interventions:   Drug: Bakuchiol;   Drug: Retinol
Sponsor:   University of California, Davis
Recruiting - verified April 2017


The Effect of Almonds on Skin Lipids and Wrinkles


Condition:   Rhytides
Intervention:   Other: Almonds
Sponsor:   University of California, Davis
Recruiting - verified November 2016


Silk'n HST Device Usability and Self Selection Study


Condition:   Wrinkles
Intervention:   Device: Silk'h HST treatment
Sponsor:   Home Skinovations Ltd.
Completed - verified September 2016


Silk'n HST for Wrinkle Reduction - Clinical Study Protocol


Condition:   Wrinkles
Intervention:   Device: Silk'n HST
Sponsor:   Home Skinovations Ltd.
Completed - verified September 2016


Study of a Novel Microlens Array Device for Skin Rejuvenation


Conditions:   Wrinkles;   Scars
Intervention:   Device: Microlens Array
Sponsor:   Cutera Inc.
Recruiting - verified August 2016


Autologous Platelet Rich Plasma Combined to Hyaluronic Acid Obtained With Regen-Kit BCT-HA in Aesthetic Medicine


Condition:   Skin Wrinkling
Intervention:   Device: Regenkit BCT-HA Cellular Matrix
Sponsor:   Regen Lab SA
Completed - verified September 2016


Emervel for the Correction of Lower Face Wrinkles & Folds


Conditions:   Nasolabial Folds;   Marionette Lines;   Wrinkles
Intervention:   Device: Emervel Classic and/or Deep Treatment Group
Sponsor:   Galderma Laboratories, L.P.
Completed - verified December 2016


Comparison of Dysport Reconstitution at 1.5 mL and 2.5 mL for the Treatment of Moderate to Severe Glabellar Lines


Conditions:   Glabellar Lines;   Wrinkles
Interventions:   Device: Dysport reconstituted at 1.5 mL (0.05 mL/injection);   Device: Dysport reconstituted at 2.5 mL (0.08 mL/injection)
Sponsor:   Galderma Laboratories, L.P.
Completed - verified December 2016


Non-comparative Evaluation of Facial Expressions Following Lower Face Correction Using Emervel Classic and Emervel Deep


Conditions:   Nasolabial Folds;   Wrinkles
Interventions:   Device: Emervel Classic;   Device: Emervel Deep
Sponsor:   Galderma Laboratories, L.P.
Completed - verified July 2016


Comparison of AmnioFix Laser and Standard of Care Treatment


Condition:   Rhytides
Interventions:   Device: AmnioFix plus Standard of Care;   Procedure: Standard of Care
Sponsor:   University of California, San Francisco
Withdrawn - verified May 2017


Evaluate the Performance of the PicoWayTM Picosecond Fractional Laser for Wrinkles Reduction


Condition:   Unwanted Wrinkles
Intervention:   Device: PicoWayTM
Sponsor:   Syneron Medical
Active, not recruiting - verified April 2017


Sculptra Aesthetic Post-Approval Study


Conditions:   Nasolabial Fold Contour Deficiencies;   Wrinkles
Intervention:   Device: injectable poly-L-lactic acid Sculptra Aesthetic
Sponsor:   Galderma Laboratories, L.P.
Active, not recruiting - verified June 2016


Study of Intradermal Injections of RCS-01 in Male and Female Subjects


Conditions:   Intrinsic Aging of Skin;   Skin Wrinkling;   Solar Degeneration of Skin
Interventions:   Drug: RCS-01;   Drug: Placebo;   Device: Sham injection
Sponsors:   RepliCel Life Sciences, Inc.;   JensonR+ Limited;   PHARMALOG Institut für klinische Forschung GmbH;   Syreon Corporation;   Innovacell Biotechnologie AG;   Datinf GmbH
Active, not recruiting - verified April 2017


DermaVeil Versus Sculptra for the Treatment of Nasolabial Folds Wrinkles


Condition:   Face; Atrophy
Interventions:   Device: DermaVeil right with left side Sculptra left side;   Device: DermaVeil left with left side Sculptra right side
Sponsor:   DermAvance
Active, not recruiting - verified November 2016


A Safety and Efficacy Study of OnabotulinumtoxinA in Upper Facial Rhytides


Conditions:   Facial Rhytides;   Glabellar Rhytides
Interventions:   Biological: OnabotulinumtoxinA;   Drug: Normal Saline
Sponsor:   Allergan
Completed - verified November 2016


A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides


Conditions:   Forehead Rhytides;   Glabellar Rhytides
Interventions:   Biological: OnabotulinumtoxinA;   Drug: Normal Saline
Sponsor:   Allergan
Completed - verified October 2016


Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study)


Conditions:   Facial Rhytides;   Crow's Feet Lines;   Glabellar Lines;   Nasolabial Fold
Interventions:   Biological: onabotulinumtoxinA;   Drug: bimatoprost ophthalmic solution 0.03%;   Device: JUVÉDERM® ULTRA XC;   Device: JUVÉDERM® ULTRA PLUS XC;   Device: JUVÉDERM® VOLUMA® XC
Sponsor:   Allergan
Completed - verified July 2016


Impact of M22 Synergistic Sequential Treatment (SST)


Condition:   Improvement of Wrinkles/Elastosis and/or Pigmentation
Intervention:   Device: M22 IPL and ResurFX
Sponsor:   Lumenis Ltd.
Completed - verified September 2016


A Pilot Study Testing Onabotulinum Toxin A Versus Incobotulinum Toxin A Injections for Facial Wrinkles


Condition:   Wrinkles
Interventions:   Drug: Onabotulinum Toxin A;   Drug: Incobotulinum Toxin A
Sponsor:   Northwestern University
Active, not recruiting - verified December 2016


Impact of Synergistic Sequential Treatment (SST)


Condition:   Improvement of Wrinkles/Elastosis as Well as General Skin Tone
Interventions:   Device: M22 ResurFX;   Device: M22 ResurFX and QS
Sponsor:   Lumenis Ltd.
Completed - verified January 2017


Treatment of Forehead/Glabellar Rhytide Complex With Botulinum Toxin A Injection


Conditions:   Forehead Rhytid Complex;   Glabellar Rhytid Complex
Intervention:   Procedure: Botulinum Toxin A
Sponsor:   Northwestern University
Active, not recruiting - verified February 2017


Fractional Laser vs. Ultrasound for Periorbital Wrinkles


Condition:   Wrinkles
Intervention:   Procedure: Laser treatment
Sponsor:   Northwestern University
Active, not recruiting - verified February 2017


Evaluation of Safety and Efficacy of Using Venus Freeze™ (MP)2 V2 System for Wrinkles Rhytides and Cellulite Treatment


Conditions:   Wrinkled Structure;   Circumference Reduction
Intervention:   Device: Venus Freeze (MP2 V2 System
Sponsor:   Venus Concept
Completed - verified June 2015


Autologous Fibroblast Transplantation in Facial Deformities


Conditions:   Nasolabial Folds;   Glabellar Crease;   Deep Wrinkles of the Forehead;   Acne Scars
Interventions:   Biological: Fibroblast;   Biological: fibroblast and gel
Sponsor:   Royan Institute
Completed - verified May 2010


Wrinkle Injection With Autologous Platelet Rich Plasma Study


Condition:   Wrinkles
Intervention:   Device: MyCells® (injection of platelet rich plasma)
Sponsor:   Novena Medical Center
Withdrawn - verified September 2016

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