NCT02877758

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_1

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

August 19, 2016

Last Update Submit

August 23, 2016

Conditions

Aging

Keywords

cutaneous agingskin rejuvenationwrinkles

Outcome Measures

Primary Outcomes (1)

  • Validated Assessment Scales for Age-related Changes of the Face

    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)

    3 months

Secondary Outcomes (2)

  • Skin quality assessment

    3 months

  • Subject Satisfaction With the Results

    3 months

Study Arms (2)

Experimental

EXPERIMENTAL

Tomorrowlabs cosmeceutical formulation is applied to the face of the subjects twice daily for 3 consecutive months.

Other: Tomorrowlabs cosmeceutical formulation

Control

SHAM COMPARATOR

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

Interventions

Tomorrowlabs cosmeceutical formulationOTHER
Also known as: HSF Cellular Age Reversal and Repair, HSF Day Catalyst
Experimental
Sham cosmeceutical formulationOTHER
Control

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Narins RS, Carruthers J, Flynn TC, Geister TL, Gortelmeyer R, Hardas B, Himmrich S, Jones D, Kerscher M, de Maio M, Mohrmann C, Pooth R, Rzany B, Sattler G, Buchner L, Benter U, Breitscheidel L, Carruthers A. Validated assessment scales for the lower face. Dermatol Surg. 2012 Feb;38(2 Spec No.):333-42. doi: 10.1111/j.1524-4725.2011.02247.x.

    PMID: 22316189BACKGROUND

  • Carruthers J, Flynn TC, Geister TL, Gortelmeyer R, Hardas B, Himmrich S, Jones D, Kerscher M, de Maio M, Mohrmann C, Narins RS, Pooth R, Rzany B, Sattler G, Buchner L, Benter U, Breitscheidel L, Carruthers A. Validated assessment scales for the mid face. Dermatol Surg. 2012 Feb;38(2 Spec No.):320-32. doi: 10.1111/j.1524-4725.2011.02251.x.

    PMID: 22316188BACKGROUND

  • Flynn TC, Carruthers A, Carruthers J, Geister TL, Gortelmeyer R, Hardas B, Himmrich S, Kerscher M, de Maio M, Mohrmann C, Narins RS, Pooth R, Rzany B, Sattler G, Buchner L, Benter U, Fey C, Jones D. Validated assessment scales for the upper face. Dermatol Surg. 2012 Feb;38(2 Spec No.):309-19. doi: 10.1111/j.1524-4725.2011.02248.x.

    PMID: 22316187BACKGROUND

MeSH Terms

Interventions

Wound Healing

Intervention Hierarchy (Ancestors)

RegenerationBiological Phenomena

Study Officials

  • Raphael Wenny, MD

    JKU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominik Thor, PhD

CONTACT

+4369911917515dominik@thor.at

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2016

First Posted

August 24, 2016

Study Start

September 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

August 25, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share