Assessment of the activity of a new cream containing betamethasone dipropionate at 0.010%, 0.025% and 0.050% versus reference products using a vasoconstriction assay in healthy subjects.

• Register: EUCTR
• Last refreshed on: 7 January 2019
• Main ID: EUCTR2008-007173-20-FR
• Date of registration: 16/03/2009
• Prospective Registration: No
• Primary sponsor: Pierre Fabre Dermatologie represented by Institut de Recherche Pierre Fabre
• Public title: Assessment of the activity of a new cream containing betamethasone dipropionate at 0.010%, 0.025% and 0.050% versus reference products using a vasoconstriction assay in healthy subjects.
• Scientific title: Assessment of the activity of a new cream containing betamethasone dipropionate at 0.010%, 0.025% and 0.050% versus reference products using a vasoconstriction assay in healthy subjects.
• Date of first enrolment: 19/02/2009
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-007173-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: no; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: yes; Other trial design description: intra-individual comparison; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: yes; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion criteria:
The subjects must fulfil all the following criteria to enter the study:
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
4. Subject non smoking or smoking less than 5 cigarettes/day.
5. Subjects demonstrating adequate vasoconstriction to topical corticosteroids ( i.e. responders) Diprosone® cream (non-occlusive 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. non-excessive hair on tested areas).
7. For women:
7.1. of childbearing potential who practices an effective method of contraception for at least 2 months before the study and one month after the end of the study and during the study with one of the following methods: oral contraception, Intra Uterine Device, injectable or implantable contraception;
7.2. of childbearing potential who has a negative urinary pregnancy test before final enrolment;
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 who 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) 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:
The subjects who present at least one of the following criteria will not be allowed to enter the study:
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 may interfere with interpretation of the study results.
3. Any skin disease on tested areas, (e.g. active atopic dermatitis, known contact dermatitis, psoriasis, any type of skin infection, ulcer lesion), that may interfere with interpretation of the study results.
4. Subject with known 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 (e.g. nitrates derivatives, antihypertensives antihistamines, OTC cough/cold products containing antihistamines and/or either phenypropanolamine or phentolamine etc).
6. Subject with any obvious difference in colour 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 the study or planned during 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. Subject who has received more than 4500 euros as indemnity for participating in clinical studies within the previous 12 months.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Topical treatment of inflammatory dermatosis linked to cutaneous dryness

Intervention(s)

Product Code: V0071CR
Pharmaceutical Form: Cream
INN or Proposed INN: betamethasone dipropionate
CAS Number: 5593-20-4
Current Sponsor code: V0071CR03A
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.010-
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Cutaneous use

Product Code: V0071CR
Pharmaceutical Form: Cream
INN or Proposed INN: betamethasone dipropionate
CAS Number: 5593-20-4
Current Sponsor code: V0071CR02A
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.025-
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Cutaneous use

Product Code: V0071CR
Pharmaceutical Form: Cream
INN or Proposed INN: betamethasone dipropionate
CAS Number: 5593-20-4
Current Sponsor code: V0071CR01B
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.050-
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Cutaneous use

Trade Name: DERMOVAL 0.05% Cream
Product Name: DERMOVAL 0.05% Cream
Pharmaceutical Form: Cream
INN or Proposed INN: Clobetasol propionate
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.05-

Trade Name: DIPROSONE 0.05% Cream
Product Name: DIPROSONE 0.05% Cream
Pharmaceutical Form: Cream
INN or Proposed INN: betamethasone dipropionate
CAS Number: 5593-20-4
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.05-

Trade Name: EUMOVATE 0.05% Cream
Product Name: EUMOVATE 0.05% Cream
Pharmaceutical Form: Cream
INN or Proposed INN: Clobetasone butyrate
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.05-

Primary Outcome(s)

Primary end point(s): Main criterion: * Skin colour measured by the chromameter (ChromaMeter Minolta): colorimetric parameter a* (a*=value represents the balance between red and green values). The results will be adjusted to baseline (Delta a*). 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 (Delta a*) per product/site.

Main Objective: This study is a pharmacodynamic study based on the corticosteroid induced skin vasoconstriction in healthy human skin. The main objective is to determine the place of new betamethasone dipropionate creams within the spectrum of topical corticosteroids formulation (ranking study)

Secondary Objective: NA

Secondary ID(s)

V00071CR202