Diabetes MellitusPhase 4NCT06427889
Treatment Effects of Two Pharmaceutical Skin Care Creams for Xerotic Feet Among Persons with Diabetes
A Phase 4 study testing Canoderm, Oviderm and Decubal in people with Diabetes Mellitus and Skin and Connective Tissue Diseases, run by Malmö University at 1 site in Sweden.
Trial summary
Introduction Diabetic foot-ulcers leads to decreased quality of life, risk of major amputation, and resource demanding health-care. To minimize the risk of developing foot-ulcers, persons with diabetes are given the advice to daily inspect their feet and to apply skincare formulations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Skin and Connective Tissue Diseases
- What is being tested?
- Canoderm, Oviderm and Decubal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSweden
- Study dates
- 4 Sep 2024to 7 Aug 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons above 18 years of age diagnosed with diabetes mellitus, both type I and II, with self-experienced dry skin.
- Dry skin on both feet with a Xerosis Severity Scale (XSS) score between two to six. No more than one XSS score in difference between the subjects' feet.
- Ability to understand sufficient Swedish language to complete the necessary forms and understand the procedure of the study.
Who cannot join
- Known sensibility to any of the ingredients in the products.
- Other diagnosed skin disease on the feet.
- Active lesions on either foot.
- Treatment with local medications, including topical moisturizers or keratolytic agents on the feet, within two weeks before the beginning of the study.
- Potential study subjects judged unable to comply with treatment schedule and study specific information.
- Female of childbearing potential that do not use effective medically accepted contraception.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Malmö University
Malmö, Skåne County, 21432
Tautgirdas Ruzgas professor, 46-4057431, tautgirdas.ruzgas@mau.se
Johan Engblom professor, 46-4057483, johan.engblom@mau.se
About this study
Official title: A Superiority Study Comparing Two Pharmaceutical Skin Care Creams Containing Different Humectants with a Non-humectant Containing Skin Care Cream for the Treatment of Xerotic Foot of Persons with Diabetes
Introduction Diabetic foot-ulcers leads to decreased quality of life, risk of major amputation, and resource demanding health-care. To minimize the risk of developing foot-ulcers, persons with diabetes are given the advice to daily inspect their feet and to apply skincare formulations. However, commercially available skincare products have rarely been developed and evaluated for diabetes foot care specifically. The primary aim of this randomized controlled trial (RCT) is to evaluate the effects in reducing foot xerosis in persons with diabetes without foot-ulcers using two skincare creams containing different humectants (interventions) against a cream base non-humectant (comparator). Secondary outcomes are to evaluate differences on skin barrier integrity, low-molecular weight biomarkers and skin microbiota, microcirculation including transcutaneous oxygen pressure, degree of neuropathy, and HbA1c between intervention-comparator cream. Methods Two-armed double-blind RCT. With 80% power, two-tailed significance of 2.5% in each arm, 39 study persons is needed in each arm, total 78 persons, to be able to prove a reduction of at least one category in the Xerosis Severity Scale with the intervention creams compared to the comparator. In one arm, each participant will treat one foot with one of the intervention creams (Oviderm® or Canoderm®), while the opposite foot will be treated with the comparator cream (Decubal® lipid cream®), twice a day. If needed, participants are enrolled after a wash-out period of two weeks. The participants will undergo examinations at baseline, day 14 and day 28. Discussion This RCT evaluate the potential effects of humectants in skin creams against foot xerosis in persons with diabetes. The outcomes of this trial could have implications on treatment recommendations of foot care and for the prevention of foot ulcer.
- Being tested
- Canoderm, Oviderm, Decubal
- Keywords
- Diabetes Mellitus, Dry Skin, Self Care, Dry Feet, Prevention
- Medical subject headings
- Diabetes Mellitus, Skin and Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanodermDrug
humectant
OvidermDrug
humectant + antimicrobial
DecubalDrug
Non-humectant
| Study group | Role | What they receive |
|---|---|---|
| Canoderm | Experimental | Topical on feet twice a day Receives: Drug: Canoderm |
| Oviderm | Experimental | Topical on feet twice a day Receives: Drug: Oviderm |
| Decubal | Active comparator | Topical on feet twice a day Receives: Drug: Decubal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Xerosis Severity
Change in Xerosis Severity (Scale scores 0 - 6, 6 is the worst)
Measured: 4 weeks
Secondary outcomes (4)
Transepidermal water loss
Trans epidermal water loss (TEWL) (grams per square meter per hour)
Measured: 4 weeks
Skin resistance
Skin resistance in Ohms (Ω)
Measured: 4 weeks
Skin Capacitance
Skin Capacitance in Farads (F)
Measured: 4 weeks
Skin pH
Skin pH (5-8)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start4 Sep 2024
- Primary completion7 Nov 2025 (estimated)
- Study completion7 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tautgirdas Ruzgas, Malmö University
- Investigators
- Christine Kumlien, Professor, Principal investigator, Malmo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427889
- Sponsor's protocol ID
- 2022-500907-27-01
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ericsson A, Borgstrom K, Kumlien C, Gershater Annersten M, Ruzgas T, Engblom J, Gudmundsson P, Lazer V, Jankovskaja S, Lavant E, Agren-Witteschus S, Bjorklund S, Salim S, Astrom M, Acosta S. Treatment effects of two pharmaceutical skin care creams for xerotic feet among persons with diabetes: Rationale and design of a two-armed double blind randomized controlled trial. Contemp Clin Trials Commun. 2024 Sep 16;42:101372. doi: 10.1016/j.conctc.2024.101372. eCollection 2024 Dec.
PubMed 39345688
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Superiority Study Comparing Two Pharmaceutical Skin Care Creams Containing Different Humectants with a Non-humectant Containing Skin Care Cream for the Treatment of Xerotic Foot of Persons with Diabetes
- ClinicalTrials.gov ID
- NCT06427889
- Acronym / sponsor ID
- 2022-500907-27-01
- Keywords
- Diabetes Mellitus, Dry Skin, Self Care, Dry Feet, Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 7 Nov 2025 (estimated)
- Study completion
- 7 Aug 2026 (estimated)
- First posted
- 24 May 2024 (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.
Introduction Diabetic foot-ulcers leads to decreased quality of life, risk of major amputation, and resource demanding health-care. To minimize the risk of developing foot-ulcers, persons with diabetes are given the advice to daily inspect their feet and to apply skincare formulations. However, commercially available skincare products have rarely been developed and evaluated for diabetes foot care specifically. The primary aim of this randomized controlled trial (RCT) is to evaluate the effects in reducing foot xerosis in persons with diabetes without foot-ulcers using two skincare creams containing different humectants (interventions) against a cream base non-humectant (comparator). Secondary outcomes are to evaluate differences on skin barrier integrity, low-molecular weight biomarkers and skin microbiota, microcirculation including transcutaneous oxygen pressure, degree of neuropathy, and HbA1c between intervention-comparator cream. Methods Two-armed double-blind RCT. With 80% power, two-tailed significance of 2.5% in each arm, 39 study persons is needed in each arm, total 78 persons, to be able to prove a reduction of at least one category in the Xerosis Severity Scale with the intervention creams compared to the comparator. In one arm, each participant will treat one foot with one of the intervention creams (Oviderm® or Canoderm®), while the opposite foot will be treated with the comparator cream (Decubal® lipid cream®), twice a day. If needed, participants are enrolled after a wash-out period of two weeks. The participants will undergo examinations at baseline, day 14 and day 28. Discussion This RCT evaluate the potential effects of humectants in skin creams against foot xerosis in persons with diabetes. The outcomes of this trial could have implications on treatment recommendations of foot care and for the prevention of foot ulcer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Canoderm | Experimental | Drug: CanodermTopical on feet twice a day |
| Oviderm | Experimental | Drug: OvidermTopical on feet twice a day |
| Decubal | Active comparator | Drug: DecubalTopical on feet twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persons above 18 years of age diagnosed with diabetes mellitus, both type I and II, with self-experienced dry skin.
- Dry skin on both feet with a Xerosis Severity Scale (XSS) score between two to six. No more than one XSS score in difference between the subjects' feet.
- Ability to understand sufficient Swedish language to complete the necessary forms and understand the procedure of the study.
Key exclusion criteria (6 listed)
- Known sensibility to any of the ingredients in the products.
- Other diagnosed skin disease on the feet.
- Active lesions on either foot.
- Treatment with local medications, including topical moisturizers or keratolytic agents on the feet, within two weeks before the beginning of the study.
- Potential study subjects judged unable to comply with treatment schedule and study specific information.
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 |
|---|---|---|
| Canodermhumectant | Drug | Canoderm |
| Ovidermhumectant + antimicrobial | Drug | Oviderm |
| DecubalNon-humectant | Drug | Decubal |
Primary outcome
Xerosis Severity
Time frame: 4 weeks
Change in Xerosis Severity (Scale scores 0 - 6, 6 is the worst)
4 secondary outcomes
Transepidermal water loss
Time frame: 4 weeks
Skin resistance
Time frame: 4 weeks
Skin Capacitance
Time frame: 4 weeks
Skin pH
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Derived from this study: PubMed 39345688Ericsson A, Borgstrom K, Kumlien C, Gershater Annersten M, Ruzgas T, Engblom J, Gudmundsson P, Lazer V, Jankovskaja S, Lavant E, Agren-Witteschus S, Bjorklund S, Salim S, Astrom M, Acosta S. Treatment effects of two pharmaceutical skin care creams for xerotic feet among persons with diabetes: Rationale and design of a two-armed double blind randomized controlled trial. Contemp Clin Trials Commun. 2024 Sep 16;42:101372. doi: 10.1016/j.conctc.2024.101372. eCollection 2024 Dec.
- 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.
Christine Kumlien, Professor principal investigator
Malmo University
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 Canoderm, Oviderm and Decubal in people with Diabetes Mellitus and Skin and Connective Tissue Diseases, run by Malmö University at 1 site in Sweden.
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 3 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 11 Dec 2024. 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 Sweden. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tautgirdas Ruzgas, Professor (+46406657431, tautgirdas.ruzgas@mau.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Xerosis Severity (time frame: 4 weeks). 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 NCT06427889, which also lists 1 linked publication.
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 Dec 2024.