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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
10% Cholesterol Cream
DrugA 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.
10% Urea cream
DrugA 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
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Cholesterol Cream SideExperimental treatment 1 intervention
Group B: Urea Cream SideActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Transepidermal Water Loss (TEWL)
TEWL measured using a Tewameter on the cholesterol cream-treated side versus the urea cream-treated side at each visit.
Time frame
Baseline (Week 0), Week 1, Week 2, and Week 42
Change in Skin Hydration
Skin hydration measured using a Corneometer on each treated side at each visit.
Time frame
Baseline (Week 0), Week 1, Week 2, and Week 4Secondary outcomes
1
Change in Clinical Dryness and Pruritus Score
Clinical dryness and itch severity rated on a 0-4 scale (0 = none, 4 = very severe) by the same investigator at each visit, compared between treated sides.
Time frame
Baseline (Week 0), Week 1, Week 2, and Week 42
Change in Investigator's Global Assessment (IGA) Score
Investigator-rated overall disease severity score assessed on each treated side at each visit.
Time frame
Baseline (Week 0), Week 1, Week 2, and Week 43
Change in Skin Surface pH
Skin surface pH measured with a skin pH meter on each treated side at each visit.
Time frame
Baseline (Week 0), Week 1, Week 2, and Week 44
Change in Dermatology Life Quality Index (DLQI) Score
The Dermatology Life Quality Index (DLQI) is a 10-item validated questionnaire assessing the impact of skin disease on quality of life in adult patients (aged 18 and above) over the preceding week. Each item is scored 0-3, giving a total score ranging from 0 (no impact on quality of life) to 30 (maximum impact on quality of life). Higher scores indicate a worse outcome. Scores are compared between Week 1, Week 2, and Week 4.
Time frame
Week 1, Week 2, and Week 4 (not assessed at baseline)Sponsors and contacts
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Source ClinicalTrials.gov
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