Xerosis CutisNCT05046015

Comparison Dry Foot Skin Between Diabetic and Non-diabetic Subjects and the Effects of Two Cosmetic Foot Care Products

A study testing 10% Urea foot lotion and 10% Urea foot ointment in people with Xerosis Cutis, run by Galderma R&D at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The overall aims of this study are to compare the structure and function of dry to very dry and cracked foot skin between diabetic and nondiabetic subjects and to evaluate the effects of two cosmetic leave-on products on dry and fissured diabetic foot skin. Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Xerosis Cutis
What is being tested?: 10% Urea foot lotion and 10% Urea foot ointment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteGermany
Study dates: Sep 2016to Mar 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 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

diabetics and non-diabetics
Any kind of adverse foot condition except xerosis like nail injury, ulceration, (suspected) infection including fungal infection
History of adverse foot condition except xerosis and tinea pedis, like nail injury, ulceration, pain
Mild xerosis cutis of feet (categories 1 and 2 according to Rogers et al. 1989)
Severe xerosis cutis of feet (category 6 according to Rogers et al. 1989)
Gait problems

Show all 26Show fewer

Other non-controlled chronic and/or acute skin disease except xerosis (e.g. atopic dermatitis, psoriasis, tinea pedis)
Unstable chronic systemic disease (e.g. hypertension, renal insufficiency)
Acute systemic disease (e.g. infection)
Body temperature > 38°C
Pain anywhere
Wear of compression stockings at any time
Use of topical steroids
Use of skin care leave-on products on the feet in the previous 2 weeks
Known hypersensitivity or allergy to product ingredients
Drugs that might affect sweating (oral corticosteroids, psychoactive drugs)
Topical treatments other than the study products on the test areas within14 days prior Day 0 and during the course of the study
Pedicure/ medical foot care 14 days prior D 0 and during the course of the study
Any condition/ circumstance (e.g. cognitive impairment, visual impairment) that might interfere with study compliance in the opinion of the investigator
Current participation in another clinical study
Subject is institutionalized because of legal or regulatory order
additionally only for non-diabetics: Diabetes mellitus type 2 according to Patient
additionally only for diabetics:
Charcot osteoarthropathy
Neuropathy tested with a Semmes-Weinstein monofilament (according to Bakker et al. 2012)
Absence of pedal pulses (1) Posterior tibial artery (2) Dorsalis pedis artery

Trial locations and contacts

1 site in 1 country.

Germany1 site

Charité Universitatsmedizin Berlin
Berlin

Other trials in Germany

About this study

Official title: Comparing Dry to Very Dry and Cracked Foot Skin Between Diabetic and Non-diabetic Subjects and the Effects of Two Cosmetic leave-on Foot Products: an Exploratory Study

Specific issues are:

Are there any differences between the morphological and functional characteristics of dry to very dry and cracked skin foot between diabetic and nondiabetic subjects? What are the effects of a 4-week once daily application of an intensive care foot ointment (urea 10% foot ointment) or foot lotion (10% Urea foot lotion) on the skin barrier and on clinical signs of dryness and fissures?

Read the detailed description

A long existing diabetes mellitus type II is often associated with a number of skin changes. Xerosis Cutis is the most common skin alteration. The risk of diabetics of developing a foot ulcer is estimated to be 15%. Very dry and cracked skin represents an additional risk factor, so that adequate skin care is a widely recommended intervention in diabetic patients. But there are only few studies investigating the skin barrier structure and function in diabetic patients. Available study results seem to suggest, that for instance sebum content, stratum corneum hydration, and pH are associated with Diabetes mellitus.

Specific issues are:

Conditions: Xerosis Cutis
Being tested: 10% Urea foot lotion, 10% Urea foot ointment
Keywords: Diabetes type II
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

10% Urea foot lotionOther
During the course of the study participants cleanse one foot (previously randomized) once daily using the mild cleanser "Cetaphil® Restoraderm Body Wash" and apply the product "Excipial® U10 Lipolotion 10% Urea" once daily in the evening by themselves.
10% Urea foot ointmentOther
During the course of the study participants cleanse one foot (previously randomized) once daily using the mild cleanser "Cetaphil® Restoraderm Body Wash" and apply the product "Excipial® U10 ointment10% Urea" once daily in the evening by themselves.

Study groups in NCT05046015
Study group	Role	What they receive
non diabetic	No intervention	Control Group of 20 non-diabetics. Skin measurements, evaluation of skin dryness and sampling of skin particles will be performed
moderate dryness-diabetic	Experimental	Experimental: Diabetics with moderate dryness. Intervention Group of 20 diabetics with moderate dryness 10% Urea foot lotion During the course of the study participants cleanse one foot (previously randomized) once daily using the mild cleanser "Cetaphil® Restoraderm Body Wash" and apply the product "Excipial® U10 Lipolotion 10% Urea" once daily in the evening by themselves. Receives: Other: 10% Urea foot lotion
severe dryness- diabetic	Experimental	Intervention Group of 20 diabetics with severe dryness 10% Urea foot ointment During the course of the study participants cleanse their feet once daily using the mild cleanser "Cetaphil® Restoraderm Body Wash" and apply the product "Excipial® Fuss Salbe 10% Urea" on both feet once daily in the evening by themselves. Receives: Other: 10% Urea foot ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline in Overall Dry Skin Score
Clinical assessment of the presence or severity of skin dryness using a 7 point scale at the sole of the foot (randomized). A score of '0' indicated normal skin/no sign of dryness, whereas a score of '6' indicates large-scale plates, deep erythematous fissures and cracks
Measured: Baseline; Day 28±2

Secondary outcomes (1)

Skin barrier
Transepidermal water loss: Measurement using the Tewameter®
Three replicate measurements; according to the Technical Procedures G01_A1_V01 g/m2/h
Measured: Day 0, Day 14±1,Day 28±2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2016Mar 2017

First posted16 Sep 2021
Study startSep 2016
Primary completionMar 2017
Study completionMar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Xerosis CutisStudies of the same condition, open and under way.
More trials run by Galderma R&DThe sponsor's other registered studies.
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: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Single Blind (Investigator) Non-Randomized 60 \[Anticipated\]
Masking: Single blind
Who is masked: Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05046015
Sponsor's protocol ID: RD.03.SPR.109799
Status last verified: Feb 2017
First submitted: 29 Jul 2020
Last updated: 16 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Dermatological Acceptability and Efficacy in Improving Xerosis, Skin Hydration, and Barrier Function
Xerosis, Dry Skin
RecruitingPhase 2
Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors
Acneiform Eruption Due to Chemical, Xerosis Cutis
Recruiting
Novel Skin Barrier Product Versus Petrolatum for Skin Barrier Dysfunction
Psoriasis, Atopic Dermatitis
Recruiting
Study on the Effectiveness of an Emollient Cream Containing Pre and Postbiotic and Niacinamide 4% in the Treatment of Skin Xerosis and Itching in Oncological Patients Treated with Anti-EGFR
Xerosis Cutis

All Xerosis Cutis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparing Dry to Very Dry and Cracked Foot Skin Between Diabetic and Non-diabetic Subjects and the Effects of Two Cosmetic leave-on Foot Products: an Exploratory Study
ClinicalTrials.gov ID: NCT05046015
Acronym / sponsor ID: RD.03.SPR.109799
Conditions: Xerosis Cutis
Keywords: Diabetes type II
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: Sep 2016 (actual)
Primary completion: Mar 2017 (actual)
Study completion: Mar 2017 (actual)
First posted: 16 Sep 2021 (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.

Specific issues are:

Detailed description

Specific issues are:

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3
Model description: Single Blind (Investigator) Non-Randomized 60 [Anticipated]

Arm	Type	Receives
non diabetic	No intervention	–Control Group of 20 non-diabetics. Skin measurements, evaluation of skin dryness and sampling of skin particles will be performed
moderate dryness-diabetic	Experimental	Other: 10% Urea foot lotionExperimental: Diabetics with moderate dryness. Intervention Group of 20 diabetics with moderate dryness 10% Urea foot lotion During the course of the study participants cleanse one foot (previously randomized) once daily using the mild cleanser "Cetaphil® Restoraderm Body Wash" and apply the product "Excipial® U10 Lipolotion 10% Urea" once daily in the evening by themselves.
severe dryness- diabetic	Experimental	Other: 10% Urea foot ointmentIntervention Group of 20 diabetics with severe dryness 10% Urea foot ointment During the course of the study participants cleanse their feet once daily using the mild cleanser "Cetaphil® Restoraderm Body Wash" and apply the product "Excipial® Fuss Salbe 10% Urea" on both feet once daily in the evening by themselves.

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (26 listed)

diabetics and non-diabetics
Any kind of adverse foot condition except xerosis like nail injury, ulceration, (suspected) infection including fungal infection
History of adverse foot condition except xerosis and tinea pedis, like nail injury, ulceration, pain
Mild xerosis cutis of feet (categories 1 and 2 according to Rogers et al. 1989)
Severe xerosis cutis of feet (category 6 according to Rogers et al. 1989)

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
10% Urea foot lotionDuring the course of the study participants cleanse one foot (previously randomized) once daily using the mild cleanser "Cetaphil® Restoraderm Body Wash" and apply the product "Excipial® U10 Lipolotion 10% Urea" once daily in the evening by themselves.	Other	moderate dryness-diabetic
10% Urea foot ointmentDuring the course of the study participants cleanse one foot (previously randomized) once daily using the mild cleanser "Cetaphil® Restoraderm Body Wash" and apply the product "Excipial® U10 ointment10% Urea" once daily in the evening by themselves.	Other	severe dryness- diabetic

Primary outcome

Change from Baseline in Overall Dry Skin Score
Time frame: Baseline; Day 28±2
Clinical assessment of the presence or severity of skin dryness using a 7 point scale at the sole of the foot (randomized). A score of '0' indicated normal skin/no sign of dryness, whereas a score of '6' indicates large-scale plates, deep erythematous fissures and cracks

1 secondary outcome

Skin barrier
Time frame: Day 0, Day 14±1,Day 28±2

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 16 Sep 2021.
Individual participant dataSharing planned: No

Related trials for Xerosis Cutis

Recruiting
Dermatological Acceptability and Efficacy in Improving Xerosis, Skin Hydration, and Barrier Function
Xerosis, Dry Skin
RecruitingPhase 2
Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors
Acneiform Eruption Due to Chemical, Xerosis Cutis
Recruiting
Novel Skin Barrier Product Versus Petrolatum for Skin Barrier Dysfunction
Psoriasis, Atopic Dermatitis
Recruiting
Study on the Effectiveness of an Emollient Cream Containing Pre and Postbiotic and Niacinamide 4% in the Treatment of Skin Xerosis and Itching in Oncological Patients Treated with Anti-EGFR
Xerosis Cutis

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.

Ulrike Blume -Peytavi, Prof Dr.med principal investigator

Charité Universitatsmedizin Berlin

Ulrike Blume-Peytavi, Prof Dr.med principal investigator

Charité Universitatsmedizin Berlin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 10% Urea foot lotion and 10% Urea foot ointment in people with Xerosis Cutis, run by Galderma R&D at 1 site in Germany.

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 0 inclusion and 26 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 16 Sep 2021. 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 Germany. 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?

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?

Change from Baseline in Overall Dry Skin Score (time frame: Baseline; Day 28±2). 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 NCT05046015.

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 16 Sep 2021.