Skin Diseases, MetabolicApotechNCT03192592
Safety and Effectiveness Evaluation of the Apotech® Diabetic Body Moisturizer
A study testing Body moisturizer in people with Skin Diseases, Metabolic and Skin Care, run by ANS Pharma at 1 site in Brazil.
Trial summary
Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Skin Diseases, Metabolic, Skin Care
- What is being tested?
- Body moisturizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 2 May 2017to 28 Jul 2017
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with controlled diabetes
- Any phototype and all skin types
Who cannot join
- Pregnant women
- Subjects that not match the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Allergisa Pesquisa Dermato-Cosmetica
Campinas, São Paulo - Brazil, 13087-548
About this study
Official title: Safety and Effectiveness Evaluation of a New Moisturizer Formulation With Antioxidant, Anti-inflammatory and Anti-microbial Effects in the Prevention of a Diabetic Skin Dryness and Complications
Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications.
Read the detailed description
Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications. This study aim to address the target population, subjects with controlled diabetes, to verify the improvement of texture, elasticity, and general appearance of the skin through the application of the cosmetic product Apotech®.
- Conditions
- Skin Diseases, Metabolic, Skin Care
- Being tested
- Body moisturizer
- Medical subject headings
- Skin Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body moisturizerOther
Also called Apotech® SkinCare
Daily body moisturizer application for skin protection and barrier.
| Study group | Role | What they receive |
|---|---|---|
| Body moisturizer Apotech® | Experimental | Instructions for use: Massage the product in the body twice a day (morning and evening) with gentle movements until completely absorption. Daily use for 28 days. Receives: Other: Body moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin general appearance
Standard guide for sensory claim substantiation - ASTM
Measured: 28 days
Skin texture
Standard guide for sensory claim substantiation - ASTM
Measured: 28 days
Skin hydration
Standard guide for sensory claim substantiation - ASTM
Measured: 28 days
Skin elasticity and visible cracking
Standard guide for sensory claim substantiation - ASTM
Measured: 28 days
Secondary outcomes (1)
Sensory evaluation of the product
Standard questions
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start2 May 2017
- Primary completion26 Jun 2017
- Study completion28 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Diseases, MetabolicStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study aim to verify the improvement of texture, elasticity and general appearance of the skin through the application of the cosmetic product Apotech®.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANS Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Allergisa Pesquisa Dermato-Cosmetica LTDA
- Responsible party
- Sponsor
- Investigators
- Lucas O. Guerra, MSc, Principal investigator, Allergisa Pesquisa Dermato-Cosmetica LTDA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192592
- Sponsor's protocol ID
- 060935_01
- Acronym
- Apotech
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2017
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Evaluation of a New Moisturizer Formulation With Antioxidant, Anti-inflammatory and Anti-microbial Effects in the Prevention of a Diabetic Skin Dryness and Complications
- ClinicalTrials.gov ID
- NCT03192592
- Acronym / sponsor ID
- Apotech / 060935_01
- Conditions
- Skin Diseases, Metabolic, Skin Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- ANS PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Allergisa Pesquisa Dermato-Cosmetica LTDA
- Study start
- 2 May 2017 (actual)
- Primary completion
- 26 Jun 2017 (actual)
- Study completion
- 28 Jul 2017 (estimated)
- First posted
- 20 Jun 2017 (actual)
- 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.
Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications.
Detailed description
Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications. This study aim to address the target population, subjects with controlled diabetes, to verify the improvement of texture, elasticity, and general appearance of the skin through the application of the cosmetic product Apotech®.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study aim to verify the improvement of texture, elasticity and general appearance of the skin through the application of the cosmetic product Apotech®.
| Arm | Type | Receives |
|---|---|---|
| Body moisturizer Apotech® | Experimental | Other: Body moisturizerInstructions for use: Massage the product in the body twice a day (morning and evening) with gentle movements until completely absorption. Daily use for 28 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with controlled diabetes
- Any phototype and all skin types
Key exclusion criteria (2 listed)
- Pregnant women
- Subjects that not match the inclusion criteria
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 |
|---|---|---|
| Body moisturizerAlso: Apotech® SkinCareDaily body moisturizer application for skin protection and barrier. | Other | Body moisturizer Apotech® |
Primary outcome
Skin general appearance
Time frame: 28 days
Standard guide for sensory claim substantiation - ASTM
Skin texture
Time frame: 28 days
Standard guide for sensory claim substantiation - ASTM
Skin hydration
Time frame: 28 days
Standard guide for sensory claim substantiation - ASTM
Skin elasticity and visible cracking
Time frame: 28 days
Standard guide for sensory claim substantiation - ASTM
1 secondary outcome
Sensory evaluation of the product
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
Lucas O. Guerra, MSc principal investigator
Allergisa Pesquisa Dermato-Cosmetica LTDA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body moisturizer in people with Skin Diseases, Metabolic and Skin Care, run by ANS Pharma at 1 site in Brazil.
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 2 inclusion and 2 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 28 Jun 2017. 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 Brazil. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
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 general appearance (time frame: 28 days). The study lists 4 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 28 Jun 2017.