EUCTR2013‐000715‐25‐DE.

Study name	A multi‐center, randomised, double‐blind, phase II trial with intraindividual comparison to assess superiority of soventol hydrocort 1% cream versus vehicle on lesional skin in patients with mild atopic eczema, seborrheic eczema or stasis dermatitis and to assess safety of Soventol HydroCort 1% cream
Methods	Trial design: randomised, double‐blind study Trial registration number: EUCTR2013‐000715‐25‐DE Country: Germany Outpatient or hospital: not reported Date trial conducted: from July 2013 Duration of trial participation: not reported Inclusion criteria: • Male or female aged 18 years or older • AD according to Hanifin and Rajka criteria, or seborrhoeic eczema or stasis dermatitis • Two comparable lesional areas of at least 2 cm2, with the clinical condition of AD or seborrhoeic eczema or stasis dermatitis rated mild • Lesions located contralaterally for patients with AD and stasis dermatitis • An erythema score = 1 in both lesional areas • Female of childbearing potential must either be surgically sterile or agree to use a reliable method of contraception, sexual abstinence or vasectomised partner. Exclusion criteria: · Acne, suntan, eczema other than AD, seborrhoeic eczema or stasis dermatitis, massive hyper‐ or hypopigmentation or tattoos in the treatment areas · Syphilitic or tuberculous dermatitis, varicella or vaccine reactions · Dark‐skinned persons whose skin colour prevents ready assessment of skin reactions · Drug or alcohol abuse · Pregnancy or nursing · UV‐therapy within 6 weeks · Symptoms of a clinically significant illness that may influence the outcome of the trial · Known allergic reactions to components of the investigational product/s · Treatment with systemic or locally acting medications which might counter or influence the trial aim within four weeks before the baseline visit and during the trial · Contraindications according to the summary of product characteristics of Soventol® HydroCort 0.5% and Linolacort® Hydro 1.0% · Institutionalised because of legal or regulatory order Additional design details: none
Participants	Total number randomised: not reported Age: 18 to 64 years Sex: all Ethnicity: excluded to quote: "dark‐skinned persons whose skin color prevents ready assessment of skin reactions" Duration of eczema: not reported Severity of eczema: mild Body site, number of withdrawals: not reported Notes: none
Interventions	Run‐in details: not reported Intervention: hydrocortisone 1.% cream · Concurrent treatment: not reported · Other key information: none Comparator: vehicle 0.% cream · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: not reported Notes: none
Outcomes	IMP versus vehicle with respect to the AUC of baseline corrected erythema scores · Clinical assessment of oedema/papulation, oozing/crusting, excoriations, scaling and lichenification
Starting date	Not reported
Contact information	betina.vanfuerden@bioskin.de
Notes	Funding source: MEDICE Arzneimittel Pütter GmbH & CO.KG Declarations of interest: not declared Original language of publication: English Other: none