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

Aging Clinical Trial

— REDUCEAGE  

Official title:

Investigation of a Novel Cosmeceutical to Reduce the Visible Signs of Cutaneous Aging - A Randomized Controlled Double Blind Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02877758
• Other study ID #: TMRW-CTa
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: August 19, 2016
• Last updated: August 23, 2016
• Start date: September 2016
• Est. completion date: February 2017

Study information

• Verified date: August 2016
• Source: Tomorrowlabs GmbH
• Contact: Dominik Thor, PhD
• Phone: +4369911917515
• Email: dominik[@]thor.at
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging

Intervention

Other:
• Tomorrowlabs cosmeceutical formulation

• Sham cosmeceutical formulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tomorrowlabs GmbH

References & Publications (3)

Carruthers J, Flynn TC, Geister TL, Görtelmeyer 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. — View Citation

Flynn TC, Carruthers A, Carruthers J, Geister TL, Görtelmeyer 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. — View Citation

Narins RS, Carruthers J, Flynn TC, Geister TL, Görtelmeyer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Skin quality assessment	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	3 months	No
Secondary	Subject Satisfaction With the Results	Self assessment questionnaire	3 months	No