SKIN-STIM CLINICAL REGISTRY STUDY PROTOCOL

Safety and Efficacy of Bioelectric + Biologics Combined Therapy Versus Bioelectric or Biologics Stand Alone Therapy for the Treatment of Moderate Facial Wrinkles
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier:  TBD 

Recruitment Status : As not begun 

First Posted : June 5th, 2018 
Results First Posted : TBD 
Last Update Posted : June 5th, 2018 
Sponsor:
Information provided by (Responsible Party):
SkinStim

 

Study Description
Brief Summary:
The study will enroll and treat a patients to assess improvement in the appearance of facial wrinkles utilizing a bioelectric or biologics (PRF + amniotic fluid) therapy or a combination of bioelectric and biologics therapy.
Condition or disease  Intervention/treatment  Phase 
Appearance of Facial Wrinkles Device: SkinStim Bioelectric Stimulator Device:  DermaPen micro needle array Device:  Prizm Medical Stimulator and electro massage gloves Device:  Hyrogel based skin cream Device:  LED Light and microcurrent face and neck mask. Biologics:  PRF + amniotic fluid + amniotic fluid Not Applicable

 

Detailed Description:
The study will enroll and treat a minimuof 49 subjects (23 in treatment Group A receiving a bioelectric treatment alone, 23 in treatment Group B receiving biologics treatment alone and 23 in Group C receiving combined bioelectric + biologics treatment) with moderate facial wrinkles corresponding to a grade of 4-6 on the validated Fitzpatrick Wrinkle Assessment Scale.
Study Design
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 to 400 participants
Allocation: Non-randomized physician and patient choice 
Intervention Model: Assignment by physician and patient choice 
Masking: None 
Primary Purpose: Treatment
Official Title: AOpen-Label, 3-Arm Parallel Study Comparing the Safety and Efficacy of  (1) Stand Alone Bioelectric Therapy with hydrogel skin cream versus (2) Biologics + hydrogel skin cream stand alone therapy versus (3) combined Bioelectric + Biologics Therapies with hydrogel skin cream
Study Start Date : Anticipated to be July 2018 
Actual Primary Completion Date : August 2019
Actual Study Completion Date : TBD 
Arms and Interventions
Arm  Intervention/treatment 
Group A = Active Comparator: Bioelectric Treatment Alone

Treatment of facial wrinkle with bioelectric treatment only + hydrogel skin cream
Devices: SkinStim Bioelectric Stimulation 2X a week for 30 minutes for 12 weeks + once a week 20 minutes electro face massages with Prizm Medical stimulator and conductive gloves. + hydrogel skin cream applied twice a day morning and evening. 

comparison of bioelectric versus biologics versus combined bioelectric + biologics therapies 
Group B = Active Comparator: Biologics Treatment Alone 

Treatment of facial wrinkle with PRF and amniotic fluid both delivered via a DermPen micro needle array + hydrogel skin cream 
Biologics:   Autologous PRF + amniotic fluid applied via DermaPen micro needle array delivery once a month for 3 months + hydrogel skin cream applied twice a day morning and evening 

comparison of bioelectric versus biologics versus combined bioelectric + biologics therapies 
Group C: Active Comparator: Combined Bioelectric and Biologics Treatment 

Treatment of facial wrinkle withbioelectric and biologic treatments
Devices:  SkinStim Stimulation 2X a week for 30 minutes for 12 weeks + once a week 20 minute electro face massages with Prizm Medical stimulator and conductive gloves
+
Biologics:  Autologous PRF + amniotic fluid applied via DermaPen microneedle array delivery once a month for 3 months + hydrogel skin cream applied twice a day morning and evening.

comparison of bioelectric versus biologics versus combined bioelectric + biologics therapies 
Outcome Measures

Primary Outcome Measures :

  1. Fitzpatrick Wrinkle Assessment [ Time Frame: change in Fitzpatrick Wrinkle Score between baseline and 90 days post treatment assessment. ]
    Subject photos will be evaluated using the 9-point Fitzpatrick Wrinkle Assessment Scale at all follow up visits. An improvement is noted by a decrease in the numeric Fitzpatrick Wrinkle score. The Fitzpatrick Wrinkle Assessment ranges from 1-9. Wrinkle Score between baseline and 90 days post treatment assessment. Positive values indicates an increase in score, while negative values indicate a decrease
  2. Adverse Events [ Time Frame: 90 days post treatment ]
    The rate of adverse events occurring in treatment subjects will be assessed.
Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study: 35 Years to 60 Years   (Adult)
Sexes Eligible for Study: Female or Male 
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:
  • Females 35-60 years of age with Fitzpatrick Skin Color Type I-IV.
  • Subjects with clinical evidence of facial wrinkles mild to moderate in severity as specified by a grade 4-6 on the Fitzpatrick Wrinkle Assessment Scale.
  • Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
  • Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup).
  • Willingness and ability to provide written informed consent prior to performance of any study related procedure.
Exclusion Criteria:
  • Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
  • Subjects who have had prior exposure to any hyaluronic acid, or any other filler, injection for any purpose in the 12 months preceding study enrollment through the duration of the study.
  • Subjects who have had prior exposure to any botulinum toxin for facial rhytids in the 6 months preceding study enrollment through the duration of the study.
  • Subjects who have had a prior cosmetic procedure to improve facial rhytids (i.e., rhytidectomy, periorbital or eyelid/eyebrow surgery, brow lift, CO2/erbium laser resurfacing, Thermage/Thermacool radiofrequency treatment) within 12 months or who have visible scars that may affect evaluation of response and/or quality of photography.
  • Ablative skin resurfacing on the glabellar area within the previous 6 months or during the study.
  • Retinoid, microdermabrasion, or prescription level glycolic acid treatments within 3 months prior to study participation or during the study.
  • Active cut, wound, or infection on the skin.
  • Oral Isotretinon within the past 12 months.
  • Active HSV-1.
  • History of keloids or hypertrophic scarring.
  • Existing or history of skin malignancy.
  • Any existing skin disease.
  • History of collagen or vascular disease.
  • Subjects who have implantable pacemaker, automatic implantable defibrillator/ cadioversor (AICD), or any other implantable electric device.
  • Subjects who have used, within 30 days, any medication that can cause dermal hypersensitivity or affect skin characteristics.
  • History of autoimmune disease.
  • History of any disease that inhibits pain sensation.
  • History of Diabetes I or II.
  • Concurrent therapy that, in the investigator’s opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
  • Subjects who anticipate the need for surgery or overnight hospitalization during the study.
  • Subjects who, in the Investigator’s opinion, have a history of poor cooperation, non¬compliance with medical treatment or unreliability.
  • Enrollment in any active study involving the use of investigational devices or drugs.
  • Patients diagnosed with skin or any other form of cancer.

 

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299103

 

Locations
United States, Illinois
TBD 
Sponsors and Collaborators
SkinStim a unit of Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc., 12655 W Jefferson Blvd, Los Angeles, CA 90066 – telephone (424) 291-2133  email howard@leonhardtventures.com
Investigators
Principal Investigator: TBD 
More Information
Responsible Party: SkinStim a unit of Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. 
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
First Posted: June 5th, 2018 
Results First Posted: June 5th, 2018 
Last Update Posted: June 5th, 2018 
Last Verified: June 5th, 2018 

Keywords provided by SkinStim a unit of Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. www.skin-stim.com

wrinkle

Skin-Stim www.skin-stim.com c/o

Leonhardt’s Launchpads by Cal-X Stars, 12655 W Jefferson Blvd, Los Angeles, CA 90066

Leonhardt’s Launchpads Utah, Inc. 370 S, 300 E, Salt Lake City, UT 84111
Research Lab @ 2500 S State St. #224, Salt Lake City, UT 84115

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