As it's a Mc Kensie and Stoughton test, there is no medical condition to be investigated in this trial. The intended indication for the betamethasone dipropionate shampoo is 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 : 1. Female or male healthy subject, 2. Subject aged between 18 and 50 years old. 3. Subject with skin type II to IV on the Fitzpatrick scale [3] 4. Subject non smoking of smoking less than 5 cigarettes/day. 5. Subjects demonstrating adequate vasoconstriction to topical corticosteroids ( i.e. responders) Diprosone lotion (unoccluded application of the reference for 4-6 hours screening pre-test must show a visual score of at least one unit (visual scale (0-4)). 6. Subject’s condition allowing accurate evaluations and study procedures, at the own Investigator’s judgment (e.g. excessive hair on tested areas). 7. If the Subject is a female : 7.1. of childbearing potential she practices an effective method of contraception and during the study with one of the following methods: oral contraception, Intra Uterine Device, injectable or implantable contraception, strict abstinence, condom or partner with a vasectomy; 7.2. of childbearing potential she has a negative urinary pregnancy test [at baseline]; 7.3. of non-childbearing potential, i.e. postmenopausal (absence of menstrual bleeding for 1 year, or 6 months if laboratory confirmation of hormonal status), or she had a hysterectomy, bilateral tubal ligation or bilateral ovariectomy. 8. Subject willing and able to comply with the requirements of the protocol. In particular, the Subject must adhere to the visit schedule and complete the study. 9. Subject who has understood and signed a written Informed Consent Form. 10. Subject affiliated to the French National Health system. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: 1. Pregnant women, nursing mother, or female planning a pregnancy 2. Any systemic disorder (e.g. clinically significant hypertension or circulatory disease), following Investigator judgment that would in any way confound interpretation of the study results. 3. Any skin disease on tested areas, (e.g. active atopic dermatitis, known contact dermatitis, or psoriasis), that would in any way confound interpretation of the study results. 4. Subject who has a sensitivity to topical drugs related to any component of any of the formulations being tested (for list of product ingredients see Investigational Brochure and Package insert for marketed corticosteroids). 5. Subject who takes treatment acting on vascular tone (nitrates derivatives, antihypertensives antihistamines, OTC cough/cold products containing antihistamines and/or either phenypropanolamine or phentolamine etc). 6. Subject with any obvious difference in color between arms. 7. Subject who takes more than 500 mg of caffeine per day prior to or during the study (a cup of coffee contains about 85 mg of caffeine). 8. Subject who would require shaving ventral forearms to insure consistent dose on skin surface 9. Subject with clinically significant history of alcoholism or drug abuse 10. Subject who did not respect the following wash-out period: - No use of creams, emollient s or similar products to forearms for 24 hours prior to and thorough the study. - Topical corticosteroids: 2 weeks - Systemic corticosteroids: 1 month 11. Subject currently enrolled in an investigational drug or device study or participated in such a study in the past month and is still in the exclusion period. 12. Hospitalized subject, subject deprived of freedom or adult subject under guardianship 13. Patient who has received more than 4500 Euros as indemnity for participating in clinical studies within he previous 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is a pharmacodynamic study based on the corticosteroid induced skin vasoconstriction in man. The main objective is to determine the place of a new betamethasone dipropionate shampoo within the spectrum of topical corticosteroids formulation.;Secondary Objective: To study local and general safety.;Primary end point(s): *Skin color measured by the chromameter (ChromaMeter Minolta): colorimetric parameter a*. The results will be adjusted to baseline (Da*). At each time, two successive series of measures will be performed on each test sites. For analyses, the mean of the two values will be calculated. The results will be expressed as adjusted means per time and by the mean AUC (Da*) per product/site | — |
Countries
France
Outcome results
None listed