Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigation of a Novel Cosmeceutical to Reduce the Visible Signs of Cutaneous Aging (REDUCEAGE)

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: NCT02877758
Recruitment Status : Unknown
Verified August 2016 by Tomorrowlabs GmbH.
Recruitment status was:  Not yet recruiting
First Posted : August 24, 2016
Last Update Posted : August 25, 2016
Sponsor:
Information provided by (Responsible Party):
Tomorrowlabs GmbH

Brief Summary:
Tomorrowlabs has developed a revolutionary cosmeceutical formulation to rejuvenate aging skin. Tomorrowlabs is conducting this research to study whether this cosmeceutical can reduce the visible signs of cutaneous aging.

Condition or disease Intervention/treatment Phase
Aging Other: Tomorrowlabs cosmeceutical formulation Other: Sham cosmeceutical formulation Phase 1 Phase 2

Detailed Description:
It is proposed to study a cosmeceutical formulation designed to reduce the visible signs of cutaneous aging. It is expected that daily application of the formulation may minimize wrinkles and fine lines of the face.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of a Novel Cosmeceutical to Reduce the Visible Signs of Cutaneous Aging - A Randomized Controlled Double Blind Study
Study Start Date : September 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Arm Intervention/treatment
Experimental: Experimental
Tomorrowlabs cosmeceutical formulation is applied to the face of the subjects twice daily for 3 consecutive months.
Other: Tomorrowlabs cosmeceutical formulation
Other Names:
  • HSF Cellular Age Reversal and Repair
  • HSF Day Catalyst

Sham Comparator: Control
Tomorrowlabs cosmeceutical formulation without the active ingredient is applied to the face of the subjects twice daily for 3 consecutive months.
Other: Sham cosmeceutical formulation



Primary Outcome Measures :
  1. Validated Assessment Scales for Age-related Changes of the Face [ Time Frame: 3 months ]
    A reliable tool for valid and reproducible assessment of the aging process in various face areas will be employed by our independent panel of assessors to scale the primary outcome. (1-3)


Secondary Outcome Measures :
  1. Skin quality assessment [ Time Frame: 3 months ]
    The skin scope uses black light and magnification to show variety of skin imperfections that are undetectable with the naked eye such as dry and thin skin

  2. Subject Satisfaction With the Results [ Time Frame: 3 months ]
    Self assessment questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers who desire to improve their appearance by reducing the visible signs of cutaneous aging in the face

Exclusion Criteria:

  • Subjects who have undergone facial plastic surgery or aesthetic dermatology treatments to the face (such as fillers and neuromodulators) in the past 6 months
  • Subjects with a history of collagen vascular disease, cutis laxa, connective tissue disease, psoriasis, or lupus.
  • Subjects diagnosed with scleroderma.
  • Subjects with a body mass index (BMI) > 30.
  • Subjects taking steroid therapy.

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): NCT02877758


Contacts
Layout table for location contacts
Contact: Dominik Thor, PhD +4369911917515 dominik@thor.at

Sponsors and Collaborators
Tomorrowlabs GmbH
Investigators
Layout table for investigator information
Principal Investigator: Raphael Wenny, MD JKU