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Cholesterol Cream vs Urea Cream for Skin Barrier and Quality of Life in Ichthyosis

NCT07689435 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-07-08

No results posted yet for this study

Summary

This study looks at whether a cream containing 10% cholesterol works better than a cream containing 10% urea for people with autosomal recessive congenital ichthyosis (ARCI), a rare inherited skin condition that causes dry, thickened, scaly skin from birth.

People with ARCI have a weakened skin barrier because their skin cannot properly produce or arrange the natural fats (lipids) needed to keep moisture in and irritants out. This leads to excessive water loss through the skin, dryness, itching, cracking, and a higher risk of skin infections. The current standard treatment is urea cream, which helps soften and remove scale but does not repair the underlying fat structure of the skin barrier. Cholesterol is one of the key natural fats that makes up a healthy skin barrier, so applying it directly to the skin may help rebuild that barrier more effectively than urea.

In this study, each participant will have one cream applied to one side of the body and the other cream applied to the matching area on the opposite side, so that each person acts as their own comparison. Researchers will measure how much water the skin loses (transepidermal water loss), skin hydration, and skin pH before and after treatment. They will also assess dryness and itching, take standardized clinical photographs, and ask participants to complete quality-of-life questionnaires (the Dermatology Life Quality Index, or its children's version, the Children's Dermatology Life Quality Index) as well as a satisfaction questionnaire for each cream.

The goal is to find out whether cholesterol cream restores the skin barrier better than urea cream, reduces dryness and itching more effectively, and leads to a better quality of life for people living with ARCI. The results may help guide more targeted skin care recommendations for this rare genetic condition.

This study is being conducted at the Institute of Dermatology, Bangkok, Thailand, and has been approved by the Institute's Ethics Committee.

Conditions

  • Autosomal Recessive Congenital Ichthyosis
  • Skin Barrier Dysfunction
  • Ichthyosis Inherited

Interventions

DRUG

10% Cholesterol Cream

A topical cream formulated with 10% cholesterol, a physiological lipid component of the stratum corneum lamellar lipid matrix. Applied twice daily to a designated body area in patients with autosomal recessive congenital ichthyosis (ARCI), with the aim of restoring barrier lipid structure, reducing transepidermal water loss, and improving skin hydration, dryness, and pruritus compared with the contralateral side treated with 10% urea cream.

DRUG

10% Urea cream

A topical cream formulated with 10% urea, a humectant and mild keratolytic agent representing the current standard-of-care emollient therapy for ichthyosis. Applied twice daily to the contralateral, anatomically matched body area in patients with ARCI, serving as the active comparator against 10% cholesterol cream within the same participant

Sponsors & Collaborators

  • Institute of Dermatology, Thailand

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
7 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-15
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Thailand

Study Locations

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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 NCT07689435 on ClinicalTrials.gov