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

Phase 1

• Conditions: Aging
• Interventions: Other: Sham cosmeceutical formulation; Other: Tomorrowlabs cosmeceutical formulation

• Registration Number: NCT02877758
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-19
• Last Update Submitted: 2016-08-23
• Study First Posted: 2016-08-24
• Last Update Posted: 2016-08-25
• Study Start: 2016-09
• Primary Completion: 2017-02
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Sham cosmeceutical formulation	Tomorrowlabs cosmeceutical formulation without the active ingredient is applied to the face of the subjects twice daily for 3 consecutive months.
Experimental	Tomorrowlabs cosmeceutical formulation	Tomorrowlabs cosmeceutical formulation is applied to the face of the subjects twice daily for 3 consecutive months.

Primary Outcome Measures

Name	Time	Method
Validated Assessment Scales for Age-related Changes of the Face	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

Name	Time	Method
Subject Satisfaction With the Results	3 months	Self assessment questionnaire
Skin quality assessment	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