- Trials with a EudraCT protocol (109)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (22)

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: A phase IV Multi-Center, Open-label Safety Study in pediatric Patients with atopic dermatitis, Treated with Diprolen AF Cream 0,05 % Twice daily, or diprosone ointment |
Active substance: BETAMETHASONE |
Study summary document link (including results): |
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Document reference: 41911 |
Study title: Anwendungsbeobachtung Cordes Beta Salbe |
Active substance: BETAMETHASONE |
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Document reference: 41910 |
Study title: Study of 0.01% betamethasone cream vs. placebo in steroid-sensitive dermatoses in children (1 to 12 years) – An incomplete, aborted study. Research Report 932-0460. |
Active substance: BETAMETHASONE |
Study summary document link (including results): betamethasone RR932-0460.pdf |
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Document reference: 47778 |
Study title: Study of 0.1% betamethasone cream vs placebo in steroid sensitive dermatoses in children (1 to 12 years) - an incomplete, aborted study. |
Active substance: BETAMETHASONE |
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Document reference: 41912 |
Study title: Evaluation of a new sequential treatment with an association of fusidic acid and two different steroids |
Active substance: BETAMETHASONE AND FUSIDIC ACID |
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Document reference: 41921 |
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: Fucicort fatty cream in clinically infected atopic dermatitis |
Active substance: BETAMETHASONE AND FUSIDIC ACID |
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Document reference: 45094 |
Study title: Fucicort fatty cream in clinically infected atopic dermatitis |
Active substance: BETAMETHASONE AND FUSIDIC ACID |
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Document reference: 41919 |
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: Wolf-Jurgensen, P. Efficacy of bufexamac cream versus betamethasone valerate cream in contact dermatitis: a double-blind trial. 1979; 5: 779-784Wolf-Jurgensen, P. Efficacy of bufexamac cream versus betamethasone valerate cream in contact dermatitis: a double-blind trial. 1979; 5: 779-784 |
Active substance: BUFEXAMAC |
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Document reference: 23053 |
Study title: Comparison of the efficacy of diclofenac and betamethasone following strabismus surgery. Wright M, Butt Z, McIlwaine G, Fleck B. Br J Ophthalmol. 1997 Apr;81(4):299-301. Comparison of the efficacy of diclofenac and betamethasone following strabismus surgery. Wright M, Butt Z, McIlwaine G, Fleck B. Br J Ophthalmol. 1997 Apr;81(4):299-301. |
Active substance: DICLOPHENAC AND TOBRAMYCIN |
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Document reference: 26090 |
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: A double-blind controlled trial of betamethasone dipropionate 0.05% (Diproderm) in comparison with fluocinolone acetonide 0.025% (Synalar) in psoriasis and other steroid-responsive dermatoses. |
Active substance: FLUOROCINONIDE |
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Document reference: 28253 |
Study title: Khan, S. A. and Williamson, D. M. A double-blind comparison of 1% hydrocortisone plus 10% urea ('Alphaderm') and 0.1% betamethasone 17-valerate in the treatment of non-infective inflammatory dermatoses Curr.Med.Res.Opin. 1977;5:354-358. |
Active substance: HYDROCORTIZONE AND UREA |
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Document reference: 29189 |
Study title: Effects of prenatal exposure to betamethasone and indomethacin on the glomerular filtration rate in the preterm infant. |
Active substance: INDOMETHACIN |
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Document reference: 29894 |
Study title: Efficacy and safety of loratadina-betamethasone combination in the initial treatment of severe perennial allergic rhinitis in children |
Active substance: LARATADINE |
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Document reference: 31019 |
Study title: Efficacy and safety of loratadina-betamethasone combination in the initial treatment of severe perennial allergic rhinitis in children |
Active substance: LARATADINE |
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Document reference: 31016 |
Study title: Efficacy and safety of loratadina-betamethasone combination in the initial treatment of severe perennial allergic rhinitis in children |
Active substance: LORATADINE |
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Document reference: 31466 |
Study title: Multicentre open clinical trial, in parallel groups, on the value of Oleatum emollient oil in the treatment of atopic eczema with topical corticosteroid therapy (Betamethasone-17-Valerate). |
Active substance: LIQUID PARAFFIN |
Study summary document link (including results): Article 45_Ref_C0474_Final For Submission_27 Oct 2011.xlsx |
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Document reference: 31286 |
Study title: A double-blind multicentre parallel group study comparing HOE777 fatty ointment with betamethasone valerate 0,1% fatty ointment in patients with mild to severe atopic or eczematous contact dermatitis - M. Dietz et al. - 1982 (unpublished report) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991 |
Active substance: PREDNICARBATE |
Study summary document link (including results): Prednicarbate STUDY Dietz.xls |
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Document reference: 34665 |