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Completed

NCT Number: NCT02004860

Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis

Seborrheic dermatitis is a chronic inflammatory dermatological disease, evolving by relapses, affecting mainly the face and scalp. It would be important to have a maintenance treatment for severe forms of seborrheic dermatitis witch is both effective and relatively well tolerated to reduce the frequency of relapses, prolong remissions obtained after attack treatment and reduce the use of topical steroids.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rouen University Hospital

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • in Phase 1: Attack Treatment (open)
  • over the age of eighteen patient,
  • Seborrheic dermatitis Severe,
  • participation with an informed consent,
  • Women of childbearing age in effective contraception for the duration of the study or postmenopausal women.
  • in Phase 2: Phase 2: "Randomization" (blind)
  • Patient achieved a complete or almost complete clinical remission after the initial treatment,
  • known immunodeficiency (HIV patient receiving chemotherapy) or immunosuppressive therapy or biotherapy,
  • patient taking regular systemic corticosteroids at a dose> 20 mg / day
  • 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,
  • woman pregnant, nursing or in childbearing potential without effective contraception,
  • man wishing to have a child during the study period,
  • Ultra Violet (UV) phototherapy or usual realization of UV sessions aesthetic purposes,
  • Seborrheic dermatitis symptomatic of an underlying disease known or revealing
  • history of cancer or lymphoma,
  • progressive cancer or lymphoma,
  • Seborrheic dermatitis exclusively affecting the scalp,
  • known allergy to one-component products study ,
  • malnourished patient or sick history of chronic pancreatitis by a suspect to deficiency dermatitis,
  • participation in a clinical trial on the Seborrheic dermatitis in the previous 90 days,
  • patient with lesions considered potentially malignant or pre-cancerous,
  • patient with abnormal skin barrier.

Exclusion criteria

  • in Phase 1: Attack Treatment (open)
  • 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,

Treatment and study plan

Protopic (R)

Drug

Protopic® 0.1% ointment - 2 applications per week for 6 months

Other names: Tacrolimus

Mycoster (R)

Drug

Mycoster 1% - 2 applications per week for 6 months

Other names: Ciclopirox olamine

Primary outcomes

  1. duration of the maintenance of complete or almost complete clinical remission

    Time frame: 18 months after inclusion (Visit (V) 4 last visit)

    The primary endpoint will be the duration of the maintenance of complete or almost complete clinical remission obtained after the initial treatment. This period is defined as the time from randomization to the first occurrence of relapse noted by the dermatologist.

Secondary outcomes

  1. Tolerance of 2 treatments

    Time frame: between 10 days and 18 months after inclusion (V3 (Day (D)10 to D180)), 30 days after inclusion (Visit D30), after 90 days after inclusion (D90) and after 120 days after inclusion (D120) and 180 days after inclusion (Visit V4)

    Tolerance of 2 treatments Mycoster (R) and Protocopic (R)

  2. Number of Relapses

    Time frame: 180 days after inclusion (Visit V4)

    Number of Relapses requiring the resumption of topical corticosteroid treatment,

  3. Cumulative amount of corticosteroids applied

    Time frame: between 10 days and 18 months after inclusion (V3 (D10 to D180)), 30 days after inclusion (Visit D30), after 90 days after inclusion (D90) and after 120 days after inclusion (D120) and 180 days after inclusion (Visit V4)

    Cumulative amount of corticosteroids applied by the patients during the study period to control their outbreaks

  4. quality of life of patients

    Time frame: Inclusion (visit D0) and Last visit 180 days after inclusion (Visit D180)

    quality of life of patients

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

Phase 3 : Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis on Adult Face

Acronym: Disease

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 9, 2013
Registry last updated
May 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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