Inflammatory seborrhoeic dermatitis of the scalp in adult
Conditions
Sponsors
Pierre Fabre Dermatologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Will be eligible subjects who meet the following criteria : - Patient aged above 18 years and less than 65 years, - patients with an inflammatory seborrhoeic dermatitis of the scalp defined as an involvement of at least 15% of the scalp area, - patients with inflammatory seborrhoeic dermatitis bilateral lesions of the scalp combining area on each half head with at least a 5 point sum score (erythema + scaling) on a 8 point grading score, and no more than 1 point difference between each area score, - patients with dandruff on both sides of the head, - patients who agree to stop application of topical product on the scalp (drug and/or cosmetics), - negative urine pregnancy test at inclusion for woman of child bearing potential and using an efficient contraceptive (implants, injectables, combined oral contraceptives, some IUDs or vasectomised partner; see appendix 2 -CPMP guidelines) for at least 2 months before the study and one month after the end of the study, - patient accepting to participate to the study and able to understand and sign an approved Informed Consent Form, - patient able to understand the protocol and to come to the control visits, - patient who, in the judgement of the investigator is likely to be compliant during the study, - registered with a social security or health insurance system. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Will not be included subjects who have one of the following criteria : * Criteria related to pathologies : - Patients with psoriasis of the scalp, - patients with any underlying skin disease which might interfere the seborrhoeic dermatitis evaluation. * Criteria related to treatments : - Patient with history of hypersensitivity to betamethasone (dipropionate) or ketoconazole or any ingredient of each product, - treatment with systemic antifungus and/or corticosteroids and/or retinoid and/or immunosuppressive and/or anti-infective drugs within two weeks before the inclusion visit (except inhaled steroid), - treatment with systemic lithium. * Criteria related to the population : - History of known HIV positive serology, - medical history of major medical, psychiatric illness or surgery which, in the judgement of the investigator, puts them ‘at risk’ or is likely to modify their handling of the study drug, - female who is pregnant or breast feeding or not using contraception, or planning to become pregnant, - participation to an other clinical trial in the previous month or during the study, - patient who, is not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent, - patient who, in the judgement of the investigator, is not likely to be compliant during the study, - patient who has forfeited his/her freedom by administrative or legal decision, or who is under guardianship, - patient who has received more than 4500 Euros as indemnity for participating in clinical studies within the previous12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Evolution of the clinical global sum score on each half head (i.e.=erythema +scaling) at D14;Main Objective: To assess the superiority of 0.050% betamethasone (dipropionate) shampoo (V0071 GM 01A) in comparison to ketoconazole 2% (foaming) gel on inflammatory seborrhoeic dermatitis of the scalp.;Secondary Objective: To assess the efficacy of 0.050% betamethasone (dipropionate) shampoo (V0071 GM 01A) on inflammatory seborrhoeic dermatitis of the scalp. To determine local and global tolerance of 0.050% betamethasone (dipropionate) shampoo (V0071 GM 01A) and ketoconazole 2% (foaming) gel. | — |
Countries
France
Outcome results
None listed