Skin AgingPhase 4NCT02765763
Clinical Evaluation of Day and Night Skin Care Creams Supplemented With MediCell Technology (MCT)'s Composition of Defensins and Supportive Molecules
A Phase 4 study testing 2-Minute Reveal Masque, 24/7 Barrier Repair Cream and 8-in-1 BioSerum in people with Skin Aging and Photoaging of Skin, run by Advanced Dermatology at 1 site in United States.
Trial summary
This is a placebo-controlled blinded clinical evaluation of day and night skin care creams supplemented by Medicell Technology's composition of defensins and supportive molecules determine the skin hydration and anti-aging properties of the topical test articles after repeated application to the skin of human subjects. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Photoaging of Skin
- What is being tested?
- 2-Minute Reveal Masque, 24/7 Barrier Repair Cream and 8-in-1 BioSerum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Jun 2017
- Phase
- Phase 4
- 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 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sex: Female
- Fitzpatrick Skin Types: I-VI
- Age: 40 - 75 years
- Individuals who will be able to read, understand and give an informed consent relation to the study they are participating in.
- Individuals who will be free of any dermatological or systemic disorder, which in the Principal Investigator's opinion, could interfere with the study results.
- Individuals who will be in general good health and who will complete a preliminary medical history form mandated by the clinic.
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- Individuals who will be able to and agree to cooperate with the Investigator and research staff.
- Individuals who will agree to have test products applied in accordance with the protocol and are able to complete the full course of the study.
- Individuals who will agree to have 2 biopsies on the postauricular area if randomly selected.
- Individuals who will agree to not participate in any other study during the entire length of the study and have not participated in a similar study in the past 30 days.
Who cannot join
- Individuals who are currently taking any medications (topical or systemic) that may mask or interfere with the test results.
- Individuals who have a history of any acute or chronic disease that might interfere with or increase the risk on study participation. (e.g., systemic lupus erythematosus, rheumatoid arthritis, HIV positive).
- Individuals who are diagnosed with chronic skin allergies (atopic dermatitis/eczema) or recently treated skin cancer within the last 12 months.
- Individuals who control their diabetes using insulin.
- Individuals with any history, which in the Investigator's opinion, indicates the potential for harm to the subject or places the validity of the study in jeopardy.
- Individuals who indicate that they are pregnant or are planning to become pregnant or nursing.
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- Individuals who have undergone any of the following procedures:
- Botox within 6 months before enrollment into study and until study completion
- Injectable filler within 3 months before enrollment into study and until study completion
- Lasers or tissue tightening devices (ultherapy, radiofrequency, skin tightening, microcurrent or photorejuvenation, photodynamic therapy) within 6 months before enrollment into study and until study completion
- Sculptra or Bellafill prior to enrollment into the study and until study completion
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Dermatology, LLC
Lincolnshire, Illinois, 60069
About this study
This is a placebo-controlled blinded clinical evaluation of day and night skin care creams supplemented by Medicell Technology's composition of defensins and supportive molecules determine the skin hydration and anti-aging properties of the topical test articles after repeated application to the skin of human subjects.
Read the detailed description
45 participants will be selected to participate in a placebo-controlled blinded trial comparing the use of the Full Formulas versus the Null Formulas (2 groups). 15 participants will be enrolled at each study site.
Each participant will test the Test System simultaneously as instructed: The Mask one-to-two times a week plus the Cream and the Serum twice daily (morning and evening); the detailed Directions are shown in Exhibit 2. The test System will be applied directly on face, postauricular and neck skin.
All study subjects will also be provided with Skinfo Clean But Not Dry cleanser and EltaMD UV Pure Broad Spectrum Sun Protective Factor (SPF) 47. Subjects will be instructed to wash their face twice daily with the cleanser and apply the sunscreen each morning after application of the Test System.
Both the study subjects and their physicians will be blinded in terms of the treatment group (the Full Formula or the Null Formula).
Subjects will be screening, consented and enrolled according to Good Clinical Practice.
There will be a 1-week washout of any skin care products deemed to be anti-aging. These products would include any using (as a main ingredient) antioxidants, retinol or retinoid, alpha hydroxyl acid, peptides, growth factors. Any other products that are to continue to be used must have been stable for the last 3 months and must be stable for the 12 weeks of the study.
Before beginning treatment, all participants will undergo medical imaging using the VISIA CA, QuantifiCare imaging system or similar non-invasive visual system. Additionally, their skin will be assessed for transepidermal water loss, wrinkle depth and elasticity (non invasive procedures). Optionally, skin will be tested using non-invasive methods for skin color, hydration, sebum content and will be evaluated using ultrasound scanner (DeremaLab Combo or similar).
Skin evaluation will be also performed at baseline, 6 weeks and 12 weeks using the Griffiths scale (2) as well as the skin evaluation scales for pores, superficial wrinkles, deep or muscle induced wrinkles, and skin radiancy, skin turgor, hyperpigmentation, hypopigmentation, erythema and edema in Blinded Evaluator Skin Assessment (Exhibit 3). The evaluation will be performed in person by the blinded investigators.
Subjects will complete a Consumer Questionnaire (Exhibit 4) at baseline, 6 week and 12 week visits.
Weekly phone calls will be made or emails will be sent (+/- 1 week window) to remind subjects to fill out compliance log, use mask, emphasize cream is applied before the serum. Follow-up appointments reminders will also be sent at this time.
- Conditions
- Skin Aging, Photoaging of Skin
- Being tested
- 2-Minute Reveal Masque, 24/7 Barrier Repair Cream, 8-in-1 BioSerum, Null Formula 2-Minute Reveal Masque, Null Formula 24/7 Barrier Repair Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-Minute Reveal MasqueDrug
24/7 Barrier Repair CreamDrug
8-in-1 BioSerumDrug
Null Formula 2-Minute Reveal MasqueDrug
Null Formula 24/7 Barrier Repair CreamDrug
Null Formula 8-in-1 BioSerumDrug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Sham | Sham comparator | Null Formula of the Test System Receives: Drug: Null Formula 2-Minute Reveal Masque; Drug: Null Formula 24/7 Barrier Repair Cream; Drug: Null Formula 8-in-1 BioSerum |
| Group 2 Treated | Active comparator | Full Formulas of Test System Receives: Drug: 2-Minute Reveal Masque; Drug: 24/7 Barrier Repair Cream; Drug: 8-in-1 BioSerum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for pore size
Measured: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for superficial wrinkles
Measured: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for deep wrinkles
Measured: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for skin radiancy
Measured: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for skin turgor
Measured: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for hyperpigmentation
Measured: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for hypopigmentation
Measured: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for erythema
Measured: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for edema
Measured: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for scaling and dryness
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Dermatology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy F Taub, MD, Principal investigator, Advanced Dermatology. LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765763
- Sponsor's protocol ID
- AFT Defenage
- Status last verified
- Jun 2016
- First submitted
- 11 Apr 2016
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Day and Night Skin Care Creams Supplemented With MediCell Technology (MCT)'s Composition of Defensins and Supportive Molecules
- ClinicalTrials.gov ID
- NCT02765763
- Acronym / sponsor ID
- AFT Defenage
- Conditions
- Skin Aging, Photoaging of Skin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Advanced DermatologyUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 9 May 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.
This is a placebo-controlled blinded clinical evaluation of day and night skin care creams supplemented by Medicell Technology's composition of defensins and supportive molecules determine the skin hydration and anti-aging properties of the topical test articles after repeated application to the skin of human subjects.
Detailed description
45 participants will be selected to participate in a placebo-controlled blinded trial comparing the use of the Full Formulas versus the Null Formulas (2 groups). 15 participants will be enrolled at each study site.
Each participant will test the Test System simultaneously as instructed: The Mask one-to-two times a week plus the Cream and the Serum twice daily (morning and evening); the detailed Directions are shown in Exhibit 2. The test System will be applied directly on face, postauricular and neck skin.
All study subjects will also be provided with Skinfo Clean But Not Dry cleanser and EltaMD UV Pure Broad Spectrum Sun Protective Factor (SPF) 47. Subjects will be instructed to wash their face twice daily with the cleanser and apply the sunscreen each morning after application of the Test System.
Both the study subjects and their physicians will be blinded in terms of the treatment group (the Full Formula or the Null Formula).
Subjects will be screening, consented and enrolled according to Good Clinical Practice.
There will be a 1-week washout of any skin care products deemed to be anti-aging. These products would include any using (as a main ingredient) antioxidants, retinol or retinoid, alpha hydroxyl acid, peptides, growth factors. Any other products that are to continue to be used must have been stable for the last 3 months and must be stable for the 12 weeks of the study.
Before beginning treatment, all participants will undergo medical imaging using the VISIA CA, QuantifiCare imaging system or similar non-invasive visual system. Additionally, their skin will be assessed for transepidermal water loss, wrinkle depth and elasticity (non invasive procedures). Optionally, skin will be tested using non-invasive methods for skin color, hydration, sebum content and will be evaluated using ultrasound scanner (DeremaLab Combo or similar).
Skin evaluation will be also performed at baseline, 6 weeks and 12 weeks using the Griffiths scale (2) as well as the skin evaluation scales for pores, superficial wrinkles, deep or muscle induced wrinkles, and skin radiancy, skin turgor, hyperpigmentation, hypopigmentation, erythema and edema in Blinded Evaluator Skin Assessment (Exhibit 3). The evaluation will be performed in person by the blinded investigators.
Subjects will complete a Consumer Questionnaire (Exhibit 4) at baseline, 6 week and 12 week visits.
Weekly phone calls will be made or emails will be sent (+/- 1 week window) to remind subjects to fill out compliance log, use mask, emphasize cream is applied before the serum. Follow-up appointments reminders will also be sent at this time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Sham | Sham comparator | Drug: Null Formula 2-Minute Reveal Masque, Drug: Null Formula 24/7 Barrier Repair Cream, Drug: Null Formula 8-in-1 BioSerumNull Formula of the Test System |
| Group 2 Treated | Active comparator | Drug: 2-Minute Reveal Masque, Drug: 24/7 Barrier Repair Cream, Drug: 8-in-1 BioSerumFull Formulas of Test System |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Sex: Female
- Fitzpatrick Skin Types: I-VI
- Age: 40 - 75 years
- Individuals who will be able to read, understand and give an informed consent relation to the study they are participating in.
- Individuals who will be free of any dermatological or systemic disorder, which in the Principal Investigator's opinion, could interfere with the study results.
Key exclusion criteria (11 listed)
- Individuals who are currently taking any medications (topical or systemic) that may mask or interfere with the test results.
- Individuals who have a history of any acute or chronic disease that might interfere with or increase the risk on study participation. (e.g., systemic lupus erythematosus, rheumatoid arthritis, HIV positive).
- Individuals who are diagnosed with chronic skin allergies (atopic dermatitis/eczema) or recently treated skin cancer within the last 12 months.
- Individuals who control their diabetes using insulin.
- Individuals with any history, which in the Investigator's opinion, indicates the potential for harm to the subject or places the validity of the study in jeopardy.
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 |
|---|---|---|
| 2-Minute Reveal Masque | Drug | Group 2 Treated |
| 24/7 Barrier Repair Cream | Drug | Group 2 Treated |
| 8-in-1 BioSerum | Drug | Group 2 Treated |
| Null Formula 2-Minute Reveal Masque | Drug | Group 1 Sham |
| Null Formula 24/7 Barrier Repair Cream | Drug | Group 1 Sham |
| Null Formula 8-in-1 BioSerum | Drug | Group 1 Sham |
Primary outcome
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for pore size
Time frame: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for superficial wrinkles
Time frame: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for deep wrinkles
Time frame: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for skin radiancy
Time frame: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for skin turgor
Time frame: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for hyperpigmentation
Time frame: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for hypopigmentation
Time frame: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for erythema
Time frame: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for edema
Time frame: Baseline and 12 weeks
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for scaling and dryness
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- 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.
Amy F Taub, MD principal investigator
Advanced Dermatology. LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2-Minute Reveal Masque, 24/7 Barrier Repair Cream and 8-in-1 BioSerum in people with Skin Aging and Photoaging of Skin, run by Advanced Dermatology at 1 site in United States.
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 10 inclusion and 11 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: finished, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Evaluation assessing change from baseline to 12 weeks using Scale from 0 to 4 for pore size (time frame: Baseline and 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2018.