- Trials with a EudraCT protocol (341)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (39)

These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006). | |
Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records. |
Study title: Efficacy of Oilatum soap (Bar) on eczemas and dry skin and Acne-aid bar on acne. |
Active substance: Arachis oil |
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Document reference: 39796 |
Study title: A single-centre, randomised, evaluator-blinded parallel-group study to compare the efficacy and safety of Oilatum Plus (antiseptic oil-based additive) and Q.V.Bath Oil (non antiseptic oil-based bath additive) in the treatment of atopic eczema. |
Active substance: BENZALCONIUM AND LIQUID PARAFFIN AND TRICLOSAN |
Study summary document link (including results): Article 45_Ref_OL01-98-AU_C0655_Final For Submission_27 Oct 2011.xlsx |
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Document reference: 22270 |
Study title: Fucicort and Betnovate N in Various types of Infected Eczemas |
Active substance: BETAMETHASONE AND FUSIDIC ACID |
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Document reference: 41920 |
Study title: Randomised controlled trial of short bursts of a potent topical cortico steroid versus prolonged use of a mild preparation for children with mild or moderate atopic eczema. Thomas KS, Armstrong S, Avery A, Po ALW, O'Neill C, Young S, et aRandomised controlled trial of short bursts of a potent topical cortico steroid versus prolonged use of a mild preparation for children with mild or moderate atopic eczema. Thomas KS, Armstrong S, Avery A, Po ALW, O'Neill C, Young S, et a |
Active substance: BETAMETHASONE AND FUSIDIC ACID |
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Document reference: 41922 |
Study title: Prednicarbat and cetirizin dihydrochloride in the treatment of acute stage of atopic eczema in children. |
Active substance: CETIRIZINE |
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Document reference: 23679 |
Study title: Population pharmacokinetics and safety of fexofenadine hydrochloride in pediatric and adult patients with allergic rhinitis, urticaria, and/or pruritus associated with skin diseases (eczema/dermatitis, pruritus cutaneous, atopic dermatitis) under the practical clinical use |
Active substance: FEXOFENADINE |
Study summary document link (including results): Fexofenadine - Study 34.pdf |
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Document reference: 45702 |
Study title: Study of cetirizine 2hcl in the treatment of eczema induced pruritus in children. |
Active substance: CETIRIZINE |
Study summary document link (including results): A053 - Cetirizine - DE87C304.pdf |
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Document reference: 23773 |
Study title: Double-blind study of cetirizine in atopic eczema in children. |
Active substance: CETIRIZINE |
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Document reference: 23705 |
Study title: A double-blind comparison of 0.25% and 0.05% desoxymethasone, 0.1% betamethasone valerate and 1% hydroxycortisone creams in the treatment of eczema. Ashton et al. 1987 (The Journal of International Medical Research 15: 160-166) - Publication mentioned as part of CES on Desoximetasone Flubason - Sostens Ferrer F. - 09/1998 -A double-blind comparison of 0.25% and 0.05% desoxymethasone, 0.1% betamethasone valerate and 1% hydroxycortisone creams in the treatment of eczema. Ashton et al. 1987 (The Journal of International Medical Research 15: 160-166) - Publication mentioned as part of CES on Desoximetasone Flubason - Sostens Ferrer F. - 09/1998 - |
Active substance: DESOXYMETHASONE |
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Document reference: 25680 |
Study title: Efficacy of Esperson (desoxymethasone 0.05% oily cream) in psoriasis, eczema and dermatitis |
Active substance: DESOXYMETHASONE |
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Document reference: 25679 |
Study title: Clinical evaluation in the treatment of Contact dermatitis, Atopic dermatitis, Seborrhoeic dermatitis, Eczema, Psoriasis and Neurodermatitis |
Active substance: DEQUALINIUM AND XYLOMETAZOLINE |
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Document reference: 25645 |
Study title: Depigoid D. pteronyssinus: Study title: "A monocenter observational cohort study on the efficacy and safety of a 6 months Depigoid® immunotherapy in patients with atopic eczema and sensitization against house dust mites" |
Active substance: DERMATOPHAGIODES PTERONYSSIMUS |
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Document reference: 25653 |
Study title: Depigoid D. pteronyssinus: Study title: "A monocenter observational cohort study on the efficacy and safety of a 6 months Depigoid® immunotherapy in patients with atopic eczema and sensitization against house dust mites" |
Active substance: D pt, depigmented/polymerised extract |
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Document reference: 39838 |
Study title: Treatment of itching in atopic eczema with antihistamines with a low sedative profile. Doherty V, Sylvester DG, Kennedy CT, Harvey SG, Calthrop JG, Gibson JR. BMJ. 1989 Jan 14;298(6666):96. Treatment of itching in atopic eczema with antihistamines with a low sedative profile. Doherty V, Sylvester DG, Kennedy CT, Harvey SG, Calthrop JG, Gibson JR. BMJ. 1989 Jan 14;298(6666):96. |
Active substance: TRIPTOLIDINE |
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Document reference: 46857 |
Study title: Double blind, placebo controlled study of the efficacy of polytar in treatment of seborrhoeic dermatitis and eczema of the scalp. |
Active substance: TAR AND ZINC |
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Document reference: 43358 |
Study title: A comparison of the efficacy of Fucidin® H cream(2% fusidic acid/1%hydrocortisone acetate) with Fucidin® cream(2% fusidic acid) in the management of patients with mild to moderate atopic eczema |
Active substance: FUSIDIC ACID |
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Document reference: 28672 |
Study title: Prospective, bicenter, randomised, placebo-controlled, parallel group comparison trial to investigate the antiphlogistic efficacy and tolerance of a fixed combination of levomenol and heparin (Sensicutan ointment) in patients with atopic eczema |
Active substance: HEPARIN AND LEVOMENOL |
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Document reference: 29118 |
Study title: Chu-AC. Imperial College of Science, London, England. Incidence of resistance to fusidic acid in atopic eczema patients treated with topical fusidic acid, with or without topical steroid. 59th Annual Meeting American Academy of Dermatology, {59th-AAD}, 2 Mar 2001, p. abstr. 091. |
Active substance: FUSIDIC ACID |
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Document reference: 28658 |
Study title: Fucidin® ointment: survey of clinical trial. Fucidin® ointment was applied once daily to 10 children with impetigo, 2 patients with eczema and 20 adults with infected ulcers. Treatment was successful in all cases of impetigo and in patients with superficial leg ulcers whereas the treatment of 6 patients with 'deeper' ulcers was discontinued because of pain on application. Inflammation was also seen in another subject. |
Active substance: FUSIDIC ACID |
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Document reference: 28678 |
Study title: A 6-week open label, national, post-marketing surveillance program to obtain photographic documentation of mild to moderate atopic eczema lesions before and after treatment with Elidel (pimecrolimus) cream 1% in children from 2 years and above and adults with atopic ezcema |
Active substance: PIMECROLIMUS |
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Document reference: 34120 |