Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT02004860
Eligibility Criteria:
Inclusion Criteria:
* in Phase 1: Attack Treatment (open)
1. over the age of eighteen patient,
2. Seborrheic dermatitis Severe,
3. participation with an informed consent,
4. Women of childbearing age in effective contraception for the duration of the study or postmenopausal women.
* in Phase 2: Phase 2: "Randomization" (blind)
1. Patient achieved a complete or almost complete clinical remission after the initial treatment,
2. known immunodeficiency (HIV patient receiving chemotherapy) or immunosuppressive therapy or biotherapy,
3. patient taking regular systemic corticosteroids at a dose\> 20 mg / day
4. erythematous lesions with topography other than the face and evocative scalp psoriasis (elbows, knees ...), by referring to the possibility that the facial lesions correspond to lesions sebopsoriasis,
5. woman pregnant, nursing or in childbearing potential without effective contraception,
6. man wishing to have a child during the study period,
7. Ultra Violet (UV) phototherapy or usual realization of UV sessions aesthetic purposes,
8. Seborrheic dermatitis symptomatic of an underlying disease known or revealing
9. history of cancer or lymphoma,
10. progressive cancer or lymphoma,
11. Seborrheic dermatitis exclusively affecting the scalp,
12. known allergy to one-component products study ,
13. malnourished patient or sick history of chronic pancreatitis by a suspect to deficiency dermatitis,
14. participation in a clinical trial on the Seborrheic dermatitis in the previous 90 days,
15. patient with lesions considered potentially malignant or pre-cancerous,
16. patient with abnormal skin barrier.
Exclusion Criteria:
* in Phase 1: Attack Treatment (open)
1\) Patient had already been treated with Protopic ® for Seborrheic Dermatitis,
* Phase 2: "Randomization" (blind) 1) Patient with no complete or almost complete clinical remission after the initial treatment,
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02004860
Study Brief:
Protocol Section:
NCT02004860