DiabetesEarly Phase 1NCT02695706
Clinical Study, Opened, of Cutaneous Acceptability of a Topic Product in Normal Conditions of Use
A Early Phase 1 study testing Laboratoires Mercurochrome Reparador in people with Diabetes, run by LM Farma Indústria e Comércio Ltda..
Trial summary
The measured product in this research is a product for topical use, Laboratoires Mercurochrome Reparador e Protetor. The expected benefit to the use of the product is the improvement in skin hydration as measured by self perception of participant research and clinical evaluation and improvement in local… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Laboratoires Mercurochrome Reparador
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jul 2016
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants healthy research;
- Intact skin on feet - grade 0 in the Wagner scale;
- Agreement to adhere to the procedures and requirements of the study and attend to the Office (s) day (s) and time (s) set (s) for evaluations;
- Ability to consent to participate in writing;
- Age 18 to 65 years;
- Research Participants of both sexes - including at least three men;
- Introducing dry skin on feet - dermatological proof.
- Participants with diabetes whose condition is stabilized
Who cannot join
- Pregnancy and lactation; skin pathology in the product application area;
- immune impairment;
- Current use of these medications for topical or systemic use: corticoid, immunosuppressants, antihistamines, anticoagulants or birth;
- Skin diseases: psoriasis, vitiligo, atopic dermatitis;
- History of reaction to the category of the product tested;
- Other diseases or medications that may interfere directly in the study or to endanger the health of the research participant.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study, Opened, of Cutaneous Acceptability of a Topic Product in Normal Conditions of Use and Evaluation of the Effectiveness Through the Self Awareness of the Research, of Clinical Evaluations and Instrumental Measurements
The measured product in this research is a product for topical use, Laboratoires Mercurochrome Reparador e Protetor. The expected benefit to the use of the product is the improvement in skin hydration as measured by self perception of participant research and clinical evaluation and improvement in local microcirculation, assessed by instrumental measurements in feet of the study participants.
Read the detailed description
The objectives of this study is to verify the skin acceptability through the non-occurrence of adverse events and cutaneous sensations of discomfort, evaluate the moisturizing efficacy of the product through self perception of research participants and dermatological clinical evaluation to assess the improvement in local microcirculation by performing of instrumental measurements in the feet of diabetic participants, product Laboratoires Mercurochrome Repairer and Protector referred by LM FARMA INDUSTRIAL LTDA.
For this research, will be recruited up to 35 research participants who meet the inclusion / exclusion described in items 9.4 and 9.5 of the research protocol, to achieve a number of completion of 30 participants. Be recruited participants from both sexes, aged 18 and 65, which have dry skin on the feet and they are people with diabetes whose condition is stabilized.
- Conditions
- Diabetes
- Being tested
- Laboratoires Mercurochrome Reparador
- Keywords
- Diabetes, Skin acceptability, Clinical Research
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratoires Mercurochrome ReparadorDevice
Also called Urgo Repair
Developed for the treatment of damaged or fragile skin.
| Study group | Role | What they receive |
|---|---|---|
| Laboratoires Mercurochrome Reparador | Experimental | A group of patients will be treated with a new restorative skin cream consists of hyperoxygenation essential fatty acids (60% linoleic acid) which does not contain preservatives (parabens) or known allergens. Receives: Device: Laboratoires Mercurochrome Reparador |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin acceptability through the self perception of patients.
Measure the skin acceptability through the self perception of patients with the daily use of the product adding in a questionnaire the product effectiveness.
Measured: 2 months
Secondary outcomes (1)
Instrumental Performance Measures
Instrumental measurements will be carried out through the Skin-Thermometer ST equipment 500 - Courage + Khazaka in the feet of participants with the aid of a dermatologist.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LM Farma Indústria e Comércio Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandre Tepas, Graduated, Study director, Urgo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695706
- Sponsor's protocol ID
- LM Farma
- Status last verified
- Feb 2016
- First submitted
- 12 Feb 2016
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study, Opened, of Cutaneous Acceptability of a Topic Product in Normal Conditions of Use and Evaluation of the Effectiveness Through the Self Awareness of the Research, of Clinical Evaluations and Instrumental Measurements
- ClinicalTrials.gov ID
- NCT02695706
- Acronym / sponsor ID
- LM Farma
- Conditions
- Diabetes
- Keywords
- Diabetes, Skin acceptability, Clinical Research
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- LM Farma Indústria e Comércio Ltda.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 1 Mar 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.
The measured product in this research is a product for topical use, Laboratoires Mercurochrome Reparador e Protetor. The expected benefit to the use of the product is the improvement in skin hydration as measured by self perception of participant research and clinical evaluation and improvement in local microcirculation, assessed by instrumental measurements in feet of the study participants.
Detailed description
The objectives of this study is to verify the skin acceptability through the non-occurrence of adverse events and cutaneous sensations of discomfort, evaluate the moisturizing efficacy of the product through self perception of research participants and dermatological clinical evaluation to assess the improvement in local microcirculation by performing of instrumental measurements in the feet of diabetic participants, product Laboratoires Mercurochrome Repairer and Protector referred by LM FARMA INDUSTRIAL LTDA.
For this research, will be recruited up to 35 research participants who meet the inclusion / exclusion described in items 9.4 and 9.5 of the research protocol, to achieve a number of completion of 30 participants. Be recruited participants from both sexes, aged 18 and 65, which have dry skin on the feet and they are people with diabetes whose condition is stabilized.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laboratoires Mercurochrome Reparador | Experimental | Device: Laboratoires Mercurochrome ReparadorA group of patients will be treated with a new restorative skin cream consists of hyperoxygenation essential fatty acids (60% linoleic acid) which does not contain preservatives (parabens) or known allergens. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants healthy research;
- Intact skin on feet - grade 0 in the Wagner scale;
- Agreement to adhere to the procedures and requirements of the study and attend to the Office (s) day (s) and time (s) set (s) for evaluations;
- Ability to consent to participate in writing;
- Age 18 to 65 years;
Key exclusion criteria (6 listed)
- Pregnancy and lactation; skin pathology in the product application area;
- immune impairment;
- Current use of these medications for topical or systemic use: corticoid, immunosuppressants, antihistamines, anticoagulants or birth;
- Skin diseases: psoriasis, vitiligo, atopic dermatitis;
- History of reaction to the category of the product tested;
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 |
|---|---|---|
| Laboratoires Mercurochrome ReparadorAlso: Urgo RepairDeveloped for the treatment of damaged or fragile skin. | Device | Laboratoires Mercurochrome Reparador |
Primary outcome
Skin acceptability through the self perception of patients.
Time frame: 2 months
Measure the skin acceptability through the self perception of patients with the daily use of the product adding in a questionnaire the product effectiveness.
1 secondary outcome
Instrumental Performance Measures
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
- 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.
Alexandre Tepas, Graduated study director
Urgo
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Laboratoires Mercurochrome Reparador in people with Diabetes, run by LM Farma Indústria e Comércio Ltda..
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 8 inclusion and 6 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 3 Mar 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Nesser C Oliveira, Graduated (551230021316, n.oliveira@br.urgo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin acceptability through the self perception of patients. (time frame: 2 months). 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 3 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.