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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-65
SponsorInstitute of Dermatology, Thailand

About this trial

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.

Eligibility criteria

Qualifiers

Male or female patients aged 7 to 65 years

Confirmed diagnosis of Autosomal Recessive Congenital Ichthyosis (ARCI), established by history, family/genetic history, clinical presentation, and/or genetic testing

Disease activity stable (not in an acute flare)

Thai nationality

Disqualifiers

Presence of any other concurrent skin disease

Known history of allergy to any component of the study creams

Active skin infection (e.g., herpes zoster, viral, fungal, bacterial, or parasitic infection)

History of any malignancy

Trial design

Treatments tested in this trial

  • 10% Cholesterol Cream
  • 10% Urea cream

Treatment groups

24 Participants
are divided into 2 treatment groups