Xerotic Dermatitis in Aged People

Pierre Fabre

Status: Completed

Conditions: Itching Symptoms; Xerotic Dermatitis

Treatments: Device: Placebo; Device: DC086

Study type: Interventional

Funder types: Industry

Identifiers

NCT01806935

2012-A01547-36

Details and patient eligibility

About

The purpose of the study is to assess the the effect of the study product on itching symptoms associated with xerotic dermatitis in aged population

Enrollment: 442 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged from 70 years
• With xerotic dermatitis, clinically assessed ,
• At least on the anterior part of lower and/or upper limbs,
• Presenting itching xerotic dermatitis evolving from at least 3 weeks
• Intensity of itching ≥ 4 on VAS (0-10) at th inclusion time
• With MMSE score ≥ 20 dating less than 6 months
• Affiliated to a social security system, or is a beneficiary (as applicable in the national regulation)

Exclusion criteria

• Criteria related to pathologies

  • Severe form of other dermatitis requiring either systemic treatment

    -- Itching xerotic dermatitis from iatrogenic origins

  • Dermatological disease other than xerotic dermatitis which could interfere with the assessment,

  • Systemic disease that may generate xerotic dermatitis and /or pruritus

  • Immunosuppression condition,

  • History of serious disease considered by the investigator hazardous for the patient or incompatible with the study.

• Criteria related to treatment

  • Use of treatment which could interfere with the evaluation of the disease or the course of the disease

• Criteria related to the population

  • Ongoing participation to another clinical trial or participation in the previous month before the inclusion
  • Patient under guardianship or trusteeship

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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442 participants in 2 patient groups, including a placebo group

DC086

Experimental group

Description:

cream

Treatment:

Device: DC086

placebo

Placebo Comparator group

Treatment:

Device: Placebo