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

NCT ID: NCT02877758

Last Updated: 2016-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Experimental

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

Group Type EXPERIMENTAL

Tomorrowlabs cosmeceutical formulation

Intervention Type OTHER

Control

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

Group Type SHAM_COMPARATOR

Sham cosmeceutical formulation

Intervention Type OTHER

Interventions

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Tomorrowlabs cosmeceutical formulation

Intervention Type OTHER

Sham cosmeceutical formulation

Intervention Type OTHER

Other Intervention Names

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HSF Cellular Age Reversal and Repair HSF Day Catalyst

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tomorrowlabs GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raphael Wenny, MD

Role: PRINCIPAL_INVESTIGATOR

JKU

Central Contacts

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Dominik Thor, PhD

Role: CONTACT

+4369911917515

References

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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.

Reference Type BACKGROUND
PMID: 22316189 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22316188 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22316187 (View on PubMed)

Other Identifiers

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TMRW-CTa

Identifier Type: -

Identifier Source: org_study_id

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