Atopic Eczema/Dermatitis (Non-Specific)Phase 2SMARTNCT04194814
Skin bioMARkers for Atopic Eczema Therapy Evaluation
A Phase 2 study testing crisaborole (2%) ointment and betamethasone valerate 0.1% cream in people with Atopic Eczema/Dermatitis (Non-Specific), run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The study aims to investigate two new non-invasive technologies for assessing skin properties to identify and validate a range of safety biomarkers that may be considered useful as primary outcome measures for evaluating the safety of topical treatments in atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Eczema/Dermatitis (Non-Specific)
- What is being tested?
- crisaborole (2%) ointment and betamethasone valerate 0.1% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Nov 2020to 30 Sep 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers with AD defined according to the UK working party diagnostic criteria
- Male or female aged 18-65 years old at baseline (Visit 1)
- Volunteer understands the purpose, modalities and potential risk of the trial
- Participants able to read and understand English
- Participants willing to sign the informed consent
Who cannot join
- Participants with a known allergy/hypersensitivity to any of the excipients of the trial preparations.
- Participants with acne, suntan, birth marks, multiple nevi, tattoos, blemishes or dense body hair that obstruct the test areas.
- Investigator assessment of eczema severity at the treatment (anatomical) sites is almost clear or greater (score ≥1) based on the Investigators static global assessment scale at screening and baseline. At the start of the study the skin of the test sites (forearms) will therefore be clear (0) of the signs of eczema
- Participants with a condition that in the opinion of the investigator contradicts participation in the study.
- Pregnant female participants; breastfeeding female participants; and female participants of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
- Use of any topical product on the test areas within 7 days prior to Baseline/Day 1, including cosmetic moisturizers and sunscreen. Participants using any topical products on the test areas within 7 days at the screening visit will be eligible if they are willing and able to wash-out these products for 7 days in total and for the duration of the trial. Such participants will be potentially eligible at screening and will be confirmed as eligible if adequate washout is confirmed at visit 1. Use of moisturizers and/or sunscreen is permitted during the study to manage dry skin and sun exposure in areas surrounding but not on or overlapping the test areas.
Show all 11Show fewer
- Participants who have used a tanning bed within 28 days of baseline (visit 1). Participants who have used a sunbed within 28 days at the screening visit will be eligible if they are willing and able to wash-out for 28 days in total and for the duration of the trial. Such participants will be potentially eligible at screening and will be confirmed as eligible if adequate washout is confirmed at visit 1.
- Participants who have used any medication that could interfere with the trial aim prior to the start of the study (baseline/visit 1). Participants using such medication at the screening visit will be eligible if they are willing and able to wash-out these treatments for the applicable washout period as defined by in section 8.8 'Prior and Concomitant Medication' and for the duration of the trial. Such participants will be potentially eligible at screening and will be confirmed as eligible if adequate washout is confirmed at visit 1.
- Participants currently participating in another interventional clinical trial.
- Volunteer is incapable of giving fully informed consent.
- Participants judged by the PI to be inappropriate for the trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Dermatology Research, University of Sheffield Medical School, The Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: Validation of a Novel Composite of Skin Biomarkers as a Primary Outcome Measure for Evaluating the Safety of Treatments for Atopic Dermatitis: a Randomized Controlled Trial (Phase 2) Comparing the Effects of Crisaborole 2% Ointment to Betamethasone Valerate 0.1% Cream on Skin Structure and Function in Participants With Atopic Dermatitis.
The study aims to investigate two new non-invasive technologies for assessing skin properties to identify and validate a range of safety biomarkers that may be considered useful as primary outcome measures for evaluating the safety of topical treatments in atopic dermatitis. The method of assessing these biomarker technologies will be to determine whether twice daily treatment with crisaborole (2%) ointment, compared to betamethasone valerate (0.1%) cream, for up to 4 weeks, may cause skin structure or function changes, like skin atrophy, in patients with atopic dermatitis (AD).
Read the detailed description
The first-line drug treatment for mild-moderate AD are currently topical corticosteroids (TCS) with recognized efficacy. However, their prolonged or inappropriate use, can lead to local adverse effects. Side-effects of topical corticosteroids comprise a variety of skin changes in the sense of skin atrophy thinning of the skin and in some cases development of telangiectasia, spontaneous scars, folliculitis, striae distensae (stretch marks), contact dermatitis, acne or rosacea depending on potency, galenic formulation, patient age and body area to which the medication will be applied, exposure time.
Assessing the safety (local adverse effects) of current or new treatments and new treatment approaches using existing treatments through noninvasively monitor on possible early skin (subclinical) changes associated with the local clinical adverse effects of treatment may be an effective step for an enhanced AD treatment management.
Primary Aim: To further develop and validate two new non-invasive technologies for the assessment of early sub-clinical skin changes associated with adverse effects and to derive an optimum panel of safety biomarkers for use in future clinical trials of topical anti-inflammatory treatments.
The safety of two topical anti-inflammatory treatments for AD will be compared in this clinical trial, with a focus on early sub-clinical signs: crisaborole 2% ointment and betamethasone valerate 0,1% cream. Step 1 involves the collection of data on the early sub-clinical skin changes using the non-invasive technologies: OCT and FTIR spectroscopy. The data from this study will then be used to identify and refine biophysical biomarkers of skin atrophy and skin barrier disruption in steps 2 and 3.
Secondary Aim: To determine the relative local skin effects of crisaborole (2%) ointment compared to a potent and moderately potent TCS in participants with mild to moderate AD. The focus is on 'early biomarkers' of 'local skin changes'and not clinical efficacy, which has been established in previous trials.
Rationale for selecting the two comparators are related to prescription behaviors in UK (Betamethasone valerate 0,1% cream) and with no reported TCS-like local adverse effects profile (crisaborole 2% ointment)
- Conditions
- Atopic Eczema/Dermatitis (Non-Specific)
- Being tested
- crisaborole (2%) ointment, betamethasone valerate 0.1% cream
- Medical subject headings
- Dermatitis, Atopic, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crisaborole (2%) ointmentDrug
Also called Eucrisa
twice daily application on one forearm for 4 weeks (randomised site allocation)
betamethasone valerate 0.1% creamDrug
Also called Betnovate cream
twice daily application on one forearm for 4 weeks (randomised site allocation)
| Study group | Role | What they receive |
|---|---|---|
| crisaborole and topical Corticosteroid | Other | crisaborole (2%) ointment on the other forearm, twice daily application for 4 weeks (randomised site allocation)
betamethasone valerate (0.1%) cream on one forearm, twice daily application for 4 weeks (randomised site allocation) Receives: Drug: crisaborole (2%) ointment; Drug: betamethasone valerate 0.1% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Epidermal Thickness
The difference in the change in epidermal thickness, measured by structural OCT, between the sites treated with crisaborole (2%) ointment and betamethasone valerate (0.1%) cream.
Measured: Day 1 - Day 57
Secondary outcomes (8)
Analysis of Change in Objective Erythema
Analysis of the difference in the change in skin redness/erythema (relating to tolerability) during and after 28 days treatment determined by Mexameter measured on day 1, day 15, day 29 and day 57.
The Mexameter device has a range of 0-999AU (arbitrary units) and the lower the value, the better the condition of the skin. Objective redness can be classified using the following scale: 0-170AU - No erythema; 170-330AU - Minimal erythema; 330-450AU - Diffuse erythema; 450-570AU - High erythema; over 570AU - Extreme erythema
Measured: Day 1, Day 15, Day 29 and Day 57
TEWL - Skin Barrier Function
Analysis of the change in Trans-Epidermal Water Loss (TEWL, relates to skin barrier function) during and after treatment. TEWL measurements on day 1, day 15, day 29 and day 57.
Measured: Day 1, Day 15, Day 29 and Day 57
TEWL - After Tape-stripping
The difference in skin barrier integrity (TEWLts20) after 28 days treatment. TEWL measurements after tape-stripping (TEWLts20) on day 29
Measured: on Day 29, after 28 days treatment
Comparison of TEWL - After Tape-stripping
The difference in skin barrier integrity (TEWLts20) after 28 days treatment. TEWL measurements after tape-stripping (TEWLts20) on day 29
Measured: on Day 29, after 28 days treatment
Skin Dryness
The difference in the change in visual skin dryness during and after treatment. Visual skin dryness scored on day 1, day 15, day 29 and day 57. Visual skin dryness was scored using the following: 0 - Absent; 1 - Faint scaling, faint roughness and dull appearance; 2 - Small scales in combination with a few larger scales, slight roughness, whitish appearance; 3 - Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks; 4 - Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks. The lower the visual dryness score, the better the condition of the skin.
Measured: Visual skin dryness scored on day 1, day 15, day 29 and day 57
Natural Moisturising Factor (NMF)
The difference in Natural Moisturising Factor (NMF, filaggrin breakdown products) levels at the end of treatment.
3 NMF components were measured: Urocanic acid (UCA), Pyrrolidone carboxylic acid (PCA) and Free amino acids (FAA) and are expressed together as total NMF (tNMF).
Measured: Day 29
Comparison of Natural Moisturising Factor (NMF) Between Treatments
The difference in Natural Moisturising Factor (NMF, filaggrin breakdown products) levels at the end of treatment.
3 NMF components were measured: Urocanic acid (UCA), Pyrrolidone carboxylic acid (PCA) and Free amino acids (FAA) and are expressed together as total NMF (tNMF).
Measured: Day 29
Change in Visual Redness/Erythema During and After 28 Days Treatment
The difference in the change in visual skin redness during and after treatment. Visual skin redness scored on day 1, day 15, day 29 and day 57 by an experienced grader. Visual skin redness was scored using the following: 0 - No redness; 0.5/+ - Slight patchy erythema, barely perceptible; 1 - Slight uniform erythema, mild erythema; 2 - Moderate uniform erythema, moderate erythema; 3 - Strong erythema, marked erythema. The higher the visual redness score, the more inflamed the skin looks to the naked eye.
Measured: Visual skin redness scored on day 1, day 15, day 29 and day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start20 Nov 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Atopic Eczema/Dermatitis (Non-Specific)Studies 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An observer-blind forearm-controlled clinical trial in 37 AD patients, wherein each participant will undergo 4 weeks treatment with crisaborole (2%) ointment on one forearm and betamethasone valerate (0.1%) cream on the other (twice daily application in each case and randomised site allocation). At the start of the study the skin of the test sites (forearms) will be clear of the signs of AD so that the investigation focuses on local adverse effects on the skin as opposed to anti-inflammatory effects (focus on local adverse effects and not clinical efficacy). The condition of the skin will be assessed before, during and after treatment.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Michael J Cork, MB.ChB, Principal investigator, The University of Sheffield & Sheffield Teaching Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194814
- Sponsor's protocol ID
- STH19966
- Other IDs
- 2019-002643-23, WI242083-UK [Eucrisa], 269415, 2019
- Acronym
- SMART
- Status last verified
- Jun 2025
- First submitted
- 9 Dec 2019
- Last updated
- 18 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Odhiambo JA, Williams HC, Clayton TO, Robertson CF, Asher MI; ISAAC Phase Three Study Group. Global variations in prevalence of eczema symptoms in children from ISAAC Phase Three. J Allergy Clin Immunol. 2009 Dec;124(6):1251-8.e23. doi: 10.1016/j.jaci.2009.10.009.
PubMed 20004783Kerr OA, Tidman MJ, Walker JJ, Aldridge RD, Benton EC. The profile of dermatological problems in primary care. Clin Exp Dermatol. 2010 Jun;35(4):380-3. doi: 10.1111/j.1365-2230.2009.03586.x. Epub 2009 Oct 23.
PubMed 19874334Cork MJ, Danby SG, Vasilopoulos Y, Hadgraft J, Lane ME, Moustafa M, Guy RH, Macgowan AL, Tazi-Ahnini R, Ward SJ. Epidermal barrier dysfunction in atopic dermatitis. J Invest Dermatol. 2009 Aug;129(8):1892-908. doi: 10.1038/jid.2009.133. Epub 2009 Jun 4.
PubMed 19494826Punekar YS, Sheikh A. Establishing the sequential progression of multiple allergic diagnoses in a UK birth cohort using the General Practice Research Database. Clin Exp Allergy. 2009 Dec;39(12):1889-95. doi: 10.1111/j.1365-2222.2009.03366.x. Epub 2009 Oct 7.
PubMed 19817751Gupta R, Sheikh A, Strachan DP, Anderson HR. Burden of allergic disease in the UK: secondary analyses of national databases. Clin Exp Allergy. 2004 Apr;34(4):520-6. doi: 10.1111/j.1365-2222.2004.1935.x.
PubMed 15080802Lewis-Jones S, Mugglestone MA; Guideline Development Group. Management of atopic eczema in children aged up to 12 years: summary of NICE guidance. BMJ. 2007 Dec 15;335(7632):1263-4. doi: 10.1136/bmj.39405.503773.AD. No abstract available.
PubMed 18079551Hengge UR, Ruzicka T, Schwartz RA, Cork MJ. Adverse effects of topical glucocorticosteroids. J Am Acad Dermatol. 2006 Jan;54(1):1-15; quiz 16-8. doi: 10.1016/j.jaad.2005.01.010.
PubMed 16384751Schmitt J, von Kobyletzki L, Svensson A, Apfelbacher C. Efficacy and tolerability of proactive treatment with topical corticosteroids and calcineurin inhibitors for atopic eczema: systematic review and meta-analysis of randomized controlled trials. Br J Dermatol. 2011 Feb;164(2):415-28. doi: 10.1111/j.1365-2133.2010.10030.x. Epub 2010 Nov 23.
PubMed 20819086Batchelor JM, Ridd MJ, Clarke T, Ahmed A, Cox M, Crowe S, Howard M, Lawton S, McPhee M, Rani A, Ravenscroft JC, Roberts A, Thomas KS. The Eczema Priority Setting Partnership: a collaboration between patients, carers, clinicians and researchers to identify and prioritize important research questions for the treatment of eczema. Br J Dermatol. 2013 Mar;168(3):577-82. doi: 10.1111/bjd.12040. Epub 2013 Jan 18.
PubMed 22963149Byers RA, Maiti R, Danby SG, Pang EJ, Mitchell B, Carre MJ, Lewis R, Cork MJ, Matcher SJ. Sub-clinical assessment of atopic dermatitis severity using angiographic optical coherence tomography. Biomed Opt Express. 2018 Mar 29;9(4):2001-2017. doi: 10.1364/BOE.9.002001. eCollection 2018 Apr 1.
PubMed 29675335Ugryumova N, Jacobs J, Bonesi M, Matcher SJ. Novel optical imaging technique to determine the 3-D orientation of collagen fibers in cartilage: variable-incidence angle polarization-sensitive optical coherence tomography. Osteoarthritis Cartilage. 2009 Jan;17(1):33-42. doi: 10.1016/j.joca.2008.05.005. Epub 2008 Jul 14.
PubMed 18621555Danby SG, Brown K, Higgs-Bayliss T, Chittock J, Albenali L, Cork MJ. The Effect of an Emollient Containing Urea, Ceramide NP, and Lactate on Skin Barrier Structure and Function in Older People with Dry Skin. Skin Pharmacol Physiol. 2016;29(3):135-47. doi: 10.1159/000445955. Epub 2016 Jun 2.
PubMed 27251427Boncheva M, Damien F, Normand V. Molecular organization of the lipid matrix in intact Stratum corneum using ATR-FTIR spectroscopy. Biochim Biophys Acta. 2008 May;1778(5):1344-55. doi: 10.1016/j.bbamem.2008.01.022. Epub 2008 Feb 11.
PubMed 18298945Damien F, Boncheva M. The extent of orthorhombic lipid phases in the stratum corneum determines the barrier efficiency of human skin in vivo. J Invest Dermatol. 2010 Feb;130(2):611-4. doi: 10.1038/jid.2009.272. Epub 2009 Sep 3. No abstract available.
PubMed 19727117Chittock J, Brown K, Cork MJ, Danby SG. Comparing the Effect of a Twice-weekly Tacrolimus and Betamethasone Valerate Dose on the Subclinical Epidermal Barrier Defect in Atopic Dermatitis. Acta Derm Venereol. 2015 Jul;95(6):653-8. doi: 10.2340/00015555-2048.
PubMed 25594610
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Novel Composite of Skin Biomarkers as a Primary Outcome Measure for Evaluating the Safety of Treatments for Atopic Dermatitis: a Randomized Controlled Trial (Phase 2) Comparing the Effects of Crisaborole 2% Ointment to Betamethasone Valerate 0.1% Cream on Skin Structure and Function in Participants With Atopic Dermatitis.
- ClinicalTrials.gov ID
- NCT04194814
- Acronym / sponsor ID
- SMART / STH19966
- Conditions
- Atopic Eczema/Dermatitis (Non-Specific)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Posted 18 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to investigate two new non-invasive technologies for assessing skin properties to identify and validate a range of safety biomarkers that may be considered useful as primary outcome measures for evaluating the safety of topical treatments in atopic dermatitis. The method of assessing these biomarker technologies will be to determine whether twice daily treatment with crisaborole (2%) ointment, compared to betamethasone valerate (0.1%) cream, for up to 4 weeks, may cause skin structure or function changes, like skin atrophy, in patients with atopic dermatitis (AD).
Detailed description
The first-line drug treatment for mild-moderate AD are currently topical corticosteroids (TCS) with recognized efficacy. However, their prolonged or inappropriate use, can lead to local adverse effects. Side-effects of topical corticosteroids comprise a variety of skin changes in the sense of skin atrophy thinning of the skin and in some cases development of telangiectasia, spontaneous scars, folliculitis, striae distensae (stretch marks), contact dermatitis, acne or rosacea depending on potency, galenic formulation, patient age and body area to which the medication will be applied, exposure time.
Assessing the safety (local adverse effects) of current or new treatments and new treatment approaches using existing treatments through noninvasively monitor on possible early skin (subclinical) changes associated with the local clinical adverse effects of treatment may be an effective step for an enhanced AD treatment management.
Primary Aim: To further develop and validate two new non-invasive technologies for the assessment of early sub-clinical skin changes associated with adverse effects and to derive an optimum panel of safety biomarkers for use in future clinical trials of topical anti-inflammatory treatments.
The safety of two topical anti-inflammatory treatments for AD will be compared in this clinical trial, with a focus on early sub-clinical signs: crisaborole 2% ointment and betamethasone valerate 0,1% cream. Step 1 involves the collection of data on the early sub-clinical skin changes using the non-invasive technologies: OCT and FTIR spectroscopy. The data from this study will then be used to identify and refine biophysical biomarkers of skin atrophy and skin barrier disruption in steps 2 and 3.
Secondary Aim: To determine the relative local skin effects of crisaborole (2%) ointment compared to a potent and moderately potent TCS in participants with mild to moderate AD. The focus is on 'early biomarkers' of 'local skin changes'and not clinical efficacy, which has been established in previous trials.
Rationale for selecting the two comparators are related to prescription behaviors in UK (Betamethasone valerate 0,1% cream) and with no reported TCS-like local adverse effects profile (crisaborole 2% ointment)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An observer-blind forearm-controlled clinical trial in 37 AD patients, wherein each participant will undergo 4 weeks treatment with crisaborole (2%) ointment on one forearm and betamethasone valerate (0.1%) cream on the other (twice daily application in each case and randomised site allocation). At the start of the study the skin of the test sites (forearms) will be clear of the signs of AD so that the investigation focuses on local adverse effects on the skin as opposed to anti-inflammatory effects (focus on local adverse effects and not clinical efficacy). The condition of the skin will be assessed before, during and after treatment.
| Arm | Type | Receives |
|---|---|---|
| crisaborole and topical Corticosteroid | Other | Drug: crisaborole (2%) ointment, Drug: betamethasone valerate 0.1% creamcrisaborole (2%) ointment on the other forearm, twice daily application for 4 weeks (randomised site allocation) betamethasone valerate (0.1%) cream on one forearm, twice daily application for 4 weeks (randomised site allocation) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteers with AD defined according to the UK working party diagnostic criteria
- Male or female aged 18-65 years old at baseline (Visit 1)
- Volunteer understands the purpose, modalities and potential risk of the trial
- Participants able to read and understand English
- Participants willing to sign the informed consent
Key exclusion criteria (11 listed)
- Participants with a known allergy/hypersensitivity to any of the excipients of the trial preparations.
- Participants with acne, suntan, birth marks, multiple nevi, tattoos, blemishes or dense body hair that obstruct the test areas.
- Investigator assessment of eczema severity at the treatment (anatomical) sites is almost clear or greater (score ≥1) based on the Investigators static global assessment scale at screening and baseline. At the start of the study the skin of the test sites (forearms) will therefore be clear (0) of the signs of eczema
- Participants with a condition that in the opinion of the investigator contradicts participation in the study.
- Pregnant female participants; breastfeeding female participants; and female participants of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
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 |
|---|---|---|
| crisaborole (2%) ointmentAlso: Eucrisatwice daily application on one forearm for 4 weeks (randomised site allocation) | Drug | crisaborole and topical Corticosteroid |
| betamethasone valerate 0.1% creamAlso: Betnovate creamtwice daily application on one forearm for 4 weeks (randomised site allocation) | Drug | crisaborole and topical Corticosteroid |
Primary outcome
Change in Epidermal Thickness
Time frame: Day 1 - Day 57
The difference in the change in epidermal thickness, measured by structural OCT, between the sites treated with crisaborole (2%) ointment and betamethasone valerate (0.1%) cream.
8 secondary outcomes
Analysis of Change in Objective Erythema
Time frame: Day 1, Day 15, Day 29 and Day 57
TEWL - Skin Barrier Function
Time frame: Day 1, Day 15, Day 29 and Day 57
TEWL - After Tape-stripping
Time frame: on Day 29, after 28 days treatment
Comparison of TEWL - After Tape-stripping
Time frame: on Day 29, after 28 days treatment
Skin Dryness
Time frame: Visual skin dryness scored on day 1, day 15, day 29 and day 57
Natural Moisturising Factor (NMF)
Time frame: Day 29
Comparison of Natural Moisturising Factor (NMF) Between Treatments
Time frame: Day 29
Change in Visual Redness/Erythema During and After 28 Days Treatment
Time frame: Visual skin redness scored on day 1, day 15, day 29 and day 57
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20004783Odhiambo JA, Williams HC, Clayton TO, Robertson CF, Asher MI; ISAAC Phase Three Study Group. Global variations in prevalence of eczema symptoms in children from ISAAC Phase Three. J Allergy Clin Immunol. 2009 Dec;124(6):1251-8.e23. doi: 10.1016/j.jaci.2009.10.009.
- Background: PubMed 19874334Kerr OA, Tidman MJ, Walker JJ, Aldridge RD, Benton EC. The profile of dermatological problems in primary care. Clin Exp Dermatol. 2010 Jun;35(4):380-3. doi: 10.1111/j.1365-2230.2009.03586.x. Epub 2009 Oct 23.
- Background: PubMed 19494826Cork MJ, Danby SG, Vasilopoulos Y, Hadgraft J, Lane ME, Moustafa M, Guy RH, Macgowan AL, Tazi-Ahnini R, Ward SJ. Epidermal barrier dysfunction in atopic dermatitis. J Invest Dermatol. 2009 Aug;129(8):1892-908. doi: 10.1038/jid.2009.133. Epub 2009 Jun 4.
- Background: PubMed 19817751Punekar YS, Sheikh A. Establishing the sequential progression of multiple allergic diagnoses in a UK birth cohort using the General Practice Research Database. Clin Exp Allergy. 2009 Dec;39(12):1889-95. doi: 10.1111/j.1365-2222.2009.03366.x. Epub 2009 Oct 7.
- Background: PubMed 15080802Gupta R, Sheikh A, Strachan DP, Anderson HR. Burden of allergic disease in the UK: secondary analyses of national databases. Clin Exp Allergy. 2004 Apr;34(4):520-6. doi: 10.1111/j.1365-2222.2004.1935.x.
- Background: PubMed 18079551Lewis-Jones S, Mugglestone MA; Guideline Development Group. Management of atopic eczema in children aged up to 12 years: summary of NICE guidance. BMJ. 2007 Dec 15;335(7632):1263-4. doi: 10.1136/bmj.39405.503773.AD. No abstract available.
- Background: PubMed 16384751Hengge UR, Ruzicka T, Schwartz RA, Cork MJ. Adverse effects of topical glucocorticosteroids. J Am Acad Dermatol. 2006 Jan;54(1):1-15; quiz 16-8. doi: 10.1016/j.jaad.2005.01.010.
- Background: PubMed 20819086Schmitt J, von Kobyletzki L, Svensson A, Apfelbacher C. Efficacy and tolerability of proactive treatment with topical corticosteroids and calcineurin inhibitors for atopic eczema: systematic review and meta-analysis of randomized controlled trials. Br J Dermatol. 2011 Feb;164(2):415-28. doi: 10.1111/j.1365-2133.2010.10030.x. Epub 2010 Nov 23.
- Background: PubMed 22963149Batchelor JM, Ridd MJ, Clarke T, Ahmed A, Cox M, Crowe S, Howard M, Lawton S, McPhee M, Rani A, Ravenscroft JC, Roberts A, Thomas KS. The Eczema Priority Setting Partnership: a collaboration between patients, carers, clinicians and researchers to identify and prioritize important research questions for the treatment of eczema. Br J Dermatol. 2013 Mar;168(3):577-82. doi: 10.1111/bjd.12040. Epub 2013 Jan 18.
- Background: PubMed 29675335Byers RA, Maiti R, Danby SG, Pang EJ, Mitchell B, Carre MJ, Lewis R, Cork MJ, Matcher SJ. Sub-clinical assessment of atopic dermatitis severity using angiographic optical coherence tomography. Biomed Opt Express. 2018 Mar 29;9(4):2001-2017. doi: 10.1364/BOE.9.002001. eCollection 2018 Apr 1.
- Background: PubMed 18621555Ugryumova N, Jacobs J, Bonesi M, Matcher SJ. Novel optical imaging technique to determine the 3-D orientation of collagen fibers in cartilage: variable-incidence angle polarization-sensitive optical coherence tomography. Osteoarthritis Cartilage. 2009 Jan;17(1):33-42. doi: 10.1016/j.joca.2008.05.005. Epub 2008 Jul 14.
- Background: PubMed 27251427Danby SG, Brown K, Higgs-Bayliss T, Chittock J, Albenali L, Cork MJ. The Effect of an Emollient Containing Urea, Ceramide NP, and Lactate on Skin Barrier Structure and Function in Older People with Dry Skin. Skin Pharmacol Physiol. 2016;29(3):135-47. doi: 10.1159/000445955. Epub 2016 Jun 2.
- Atopic eczema in children - Guideline consultation: National Institute for Clinical Excellence, Department of Health, UKLink provided by the sponsor.
- Danby SG, Wan H, Chittock J et al. Characterisation of the skin barrier defect in atopic dermatitis using in vivo ATR-FTIR molecular spectroscopy. J Invest Dermatol 2016; 136: S182.Link provided by the sponsor.
- Lu Z, et al. Optical coherence tomography demonstrates differential epidermal thinning of human forearm volar skin after 2 weeks application of a topical corticosteroid vs a non-steroidal anti-inflammatory alternative. Proc. SPIE 2013; 85Link provided by the sponsor.
- Takada S, Naito S, Sonoda J et al. Noninvasive In Vivo Measurement of Natural Moisturizing Factor Content in Stratum Corneum of Human Skin by Attenuated Total Reflection Infrared Spectroscopy. Applied Spectroscopy 2012; 66: 26-32.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Atopic Eczema/Dermatitis (Non-Specific)
RecruitingObservational study
Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate Response to Previous Biologic Therapies.
Atopic Dermatitis, Atopic Dermatitis, Unspecified
Not yet recruitingObservational study
Atopic Dermatitis Treated With Dupilumab and JAK Inhibitors in Costa Rica
Atopic Dermatitis, Atopic Dermatitis (AD)
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.
Michael J Cork, MB.ChB principal investigator
The University of Sheffield & Sheffield Teaching Hospitals NHS FT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing crisaborole (2%) ointment and betamethasone valerate 0.1% cream in people with Atopic Eczema/Dermatitis (Non-Specific), run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 5 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 18 Jul 2025. 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 Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Epidermal Thickness (time frame: Day 1 - Day 57). 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 NCT04194814, which also lists 24 linked publications.
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 18 Jul 2025.