AgingPhase 1/2REDUCEAGENCT02877758
Investigation of a Novel Cosmeceutical to Reduce the Visible Signs of Cutaneous Aging
A Phase 1/2 study testing Tomorrowlabs cosmeceutical formulation in people with Aging, run by Tomorrowlabs GmbH.
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. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Tomorrowlabs cosmeceutical formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Feb 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers who desire to improve their appearance by reducing the visible signs of cutaneous aging in the face
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation of a Novel Cosmeceutical to Reduce the Visible Signs of Cutaneous Aging - A Randomized Controlled Double Blind Study
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Tomorrowlabs cosmeceutical formulation, Sham cosmeceutical formulation
- Keywords
- cutaneous aging, skin rejuvenation, wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tomorrowlabs cosmeceutical formulationOther
Also called HSF Cellular Age Reversal and Repair, HSF Day Catalyst
Sham cosmeceutical formulationOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Tomorrowlabs cosmeceutical formulation is applied to the face of the subjects twice daily for 3 consecutive months. Receives: 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. Receives: Other: Sham cosmeceutical formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (2)
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
Measured: 3 months
Subject Satisfaction With the Results
Self assessment questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomorrowlabs GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raphael Wenny, MD, Principal investigator, JKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877758
- Sponsor's protocol ID
- TMRW-CTa
- Acronym
- REDUCEAGE
- Status last verified
- Aug 2016
- First submitted
- 19 Aug 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22316189Carruthers 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.
PubMed 22316188Flynn 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.
PubMed 22316187
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a Novel Cosmeceutical to Reduce the Visible Signs of Cutaneous Aging - A Randomized Controlled Double Blind Study
- ClinicalTrials.gov ID
- NCT02877758
- Acronym / sponsor ID
- REDUCEAGE / TMRW-CTa
- Conditions
- Aging
- Keywords
- cutaneous aging, skin rejuvenation, wrinkles
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tomorrowlabs GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Tomorrowlabs cosmeceutical formulationTomorrowlabs cosmeceutical formulation is applied to the face of the subjects twice daily for 3 consecutive months. |
| Control | Sham comparator | Other: Sham cosmeceutical formulationTomorrowlabs cosmeceutical formulation without the active ingredient is applied to the face of the subjects twice daily for 3 consecutive months. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers who desire to improve their appearance by reducing the visible signs of cutaneous aging in the face
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tomorrowlabs cosmeceutical formulationAlso: HSF Cellular Age Reversal and Repair, HSF Day Catalyst | Other | Experimental |
| Sham cosmeceutical formulation | Other | Control |
Primary outcome
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)
2 secondary outcomes
Skin quality assessment
Time frame: 3 months
Subject Satisfaction With the Results
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- Background: PubMed 22316189Narins 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.
- Background: PubMed 22316188Carruthers 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.
- Background: PubMed 22316187Flynn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael Wenny, MD principal investigator
JKU
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tomorrowlabs cosmeceutical formulation in people with Aging, run by Tomorrowlabs GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominik Thor, PhD (+4369911917515, dominik@thor.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validated Assessment Scales for Age-related Changes of the Face (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02877758, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.