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CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS

NCT05783453 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 63

Last updated 2023-03-24

No results posted yet for this study

Summary

his was a monocentric, intra-individual study, that was performed in at least 45 valid cases (50% children ≥3 YO; 50% adults). Study duration was 168 days with five (5) visits (D0, D14, D28, D84 and D168) to the research center.

Primary objective

* Evaluation of the efficacy of LIPIKAR BAUME LIGHT AP+M in decrease the SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use;
* Evaluation of the efficacy of LIPIKAR BAUME LIGHT AP+M in maintenance the SCORAD value in child and adult subjects with mild atopic dermatitis after 84 and 168 days under normal conditions of use.

Secondary objective

* Evaluation of flares quantity and severity during 84 and 168 days of use;
* Clinical evaluation of the improvement of skin parameters such as erythema, oedema, oozing, excoriation, lichenification, dryness and desquamation of a lesional and non-lesional skin from the same individual site by dermatologist after 14, 28, 84 and 168 days;
* Self-assessment of the improvement of skin parameters such as itching, tingling, burning by subjects after 14, 28, 84 and 168 days;
* Evaluate the perceived efficacy, cosmeticity and acceptability through a subjective evaluation questionnaire after 14, 28, 84 and 168 days;
* Evaluation of the improvement in skin barrier function by the loss of transepidermic water through instrumental measurements with the Tewameter® equipment on AF and UAF after 14, 28, 84 and 168 days;
* Evaluation of the improvement of skin moisturizing through instrumental measurements with Corneometer® equipment on AF and UAF after 14, 28, 84 and 168 days;
* The folliculitis incidence after 14, 28, 84 and 168 days;
* Assessment of the improvement of the impact of quality of life through a DLQI (Dermatology Life Quality Index) questionnaire after 14, 28, 84 and 168 days;
* Assessment of global tolerance through clinical dermatological evaluation and reports performed by the subjects after using the product after 14, 28, 84 and 168 days.
* Evaluation of total body skin dryness improvement after 14, 28, 84 and 168 days.
* Illustrative clinical pictures of one or two affected areas.

Conditions

Interventions

OTHER

Cosmetic study

LIPIKAR BAUME LIGHT AP+M * Formula: 2039055 06 * Aspect: Emulsion * Batch nº: RAUO0063 * Expiry date: 10/2022 * Application area: Face and Body * Application mode: Apply to face and body twice a day. * Quantity of product to be applied: About 1 flask (400g) per month

Sponsors & Collaborators

  • Cosmetique Active International

    lead INDUSTRY

Principal Investigators

  • Daniele Miranda, MD · CIDP Brasil

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2022-07-22
Completion
2022-07-22

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05783453 on ClinicalTrials.gov