- Trials with a EudraCT protocol (1,074)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (188)

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: EVALUATION OF THE CUMMULATIVE IRRITANCY POTENIAL OF DIFFERIN GEL, 0.1% AND DIFFERIN SOLUTION, 0.1% COMPARED TO AVITA CREAM, 0.025%, AVITA GEL, 0.025%, TAZORAC GEL, 0.1%, TAZORAC GEL, 0.05%, AND RETIN-Z MICRO, 0.1% FOLLOWING REPEATED APPLICATIONS TO THE SKIN OF HUMANS - PHASE I/IV |
Active substance: ADAPALENE |
Study summary document link (including results): |
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Document reference: 46266 |
Study title: SAFETY AND EFFICACY COMPARISON OF DIFFERIN (ADAPALENE GEL) GEL, 0.1 % VERSUS RETIN-A CREAM, 0.05 % IN SUBJECTS WITH ACNE VULGARIS – PHASE IV |
Active substance: ADAPALENE |
Study summary document link (including results): |
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Document reference: 46258 |
Study title: US - BILATERAL (HALF-FACE) TOLERANCE COMPARISON OF DIFFERIN TM (ADAPALENE GEL) GEL, 0.1% VERSUS RETIN-A CREAM, 0.025% IN SUBJECTS WITH ACNE VULGARIS – PHASE IV |
Active substance: ADAPALENE |
Study summary document link (including results): |
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Document reference: 46256 |
Study title: US - BILATERAL (HALF-FACE) TOLERANCE COMPARISON OF DIFFERIN TM (ADAPALENE GEL) GEL, 0.1 % VERSUS RETIN-A CREAM, 0.025% IN SUBJECTS WITH ACNE VULGARIS – PHASE IV |
Active substance: ADAPALENE |
Study summary document link (including results): |
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Document reference: 46255 |
Study title: US - BILATERAL (HALF-FACE) TOLERANCE COMPARISON OF DIFFERIN TM (ADAPALENE GEL), 0.1% VERSUS RETIN-A CREAM, 0.025% IN SUBJECTS WITH ACNE VULGARIS – COMBINED RESULTS FROM STUDIES CR.U9606 AND CR.U9607 |
Active substance: ADAPALENE |
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Document reference: 46257 |
Study title: US - BILATERAL FACIAL TOLERANCE COMPARISON OF DIFFERIN TM (ADAPALENE GEL) GEL, 0.1% AND RETIN-A , 0.025% AND 0.05% CREAMS |
Active substance: ADAPALENE |
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Document reference: 46252 |
Study title: US - PHARMACOKINETIC EVALUATION OF DIFFERIN (ADAPALENE CREAM) CREAM, 0.1% FOLLOWING MAXIMAL EXPOSURE WITH MULTIPLE APPLICATIONS IN SUBJECTS WITH ACNE VULGARIS - PHASE I |
Active substance: ADAPALENE |
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Document reference: 46250 |
Study title: US - SAFETY AND EFFICACY COMPARISON OF DIFFERIN (ADAPALENE CREAM) CREAM, 0.1% AND DIFFERIN (ADAPALENE CREAM) CREAM VEHICLE IN THE TREATMENT OF ACNE VULGARIS - PHASE III |
Active substance: ADAPALENE |
Study summary document link (including results): |
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Document reference: 46251 |
Study title: The treatment of acne vulgaris with graded abrasive creams. |
Active substance: ALUMINIUM OXIDE |
Study summary document link (including results): |
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Document reference: 46487 |
Study title: LOCERYL - A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF VARIOUS CONCENTRATIONS OF AMOROLFINE (Ro 14-4767, LOCERYL) CREAM APPLIED ONCE DAILY TO PATIENTS WITH TINEA PEDIS |
Active substance: AMOROLFINE |
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Document reference: 21705 |
Study title: Open-Label Evaluation of 5% 5. Benzoyl Peroxide/1% Clindamycin Gel used in combination with Tazarotene 0.1% Cream and Oral Minocycline in the treatment of severe acne vulgaris. |
Active substance: BENZOYLPEROXIDE AND CLINDAMYCIN |
Study summary document link (including results): Article 45_Ref_U0515_Final for Submission_09Nov2011.xlsx |
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Document reference: 22329 |
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 |
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Document reference: 41911 |
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 |
Study summary document link (including results): |
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Document reference: 41912 |
Study title: Fucicort fatty cream in clinically infected atopic dermatitis |
Active substance: BETAMETHASONE AND FUSIDIC ACID |
Study summary document link (including results): |
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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: Efficacy and tolerability of bifonazole cream 1% and solution 1% in dermatomycosis. |
Active substance: BIFONAZOLE |
Study summary document link (including results): Bifonazole_0399.pdf |
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Document reference: 47218 |
Study title: Efficacy and tolerability of bifonazole cream 1% and solution 1% in dermatomycosis |
Active substance: BIFONAZOLE |
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Document reference: 22411 |
Study title: Efficacy and tolerability of bifonazole cream 1% and solution 1% in dermatomycosis |
Active substance: BIFONAZOLE |
Study summary document link (including results): Bayer CC_Bifonazole_0340_study_synopsis.pdf |
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Document reference: 22417 |
Study title: A multi-centre, open, non-comparative study of the efficacy and irritation potential of 4% benzoyl peroxide cream in hydrophase base (Brevoxyl) in treatment of mild to moderate acne vulgaris. |
Active substance: BENZOYL PEROXIDE |
Study summary document link (including results): |
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Document reference: 22321 |