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

NCT07689435 | Not Yet Recruiting

• 1 other identifier: IRB/IEC No. 021/2568
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Ichthyosis Inherited; Autosomal Recessive Congenital Ichthyosis; Skin Barrier Dysfunction

Keywords

Autosomal Recessive Congenital Ichthyosis; Cholesterol Cream; Urea Cream; Skin Barrier Function; Dermatology Life Quality Index

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (Week 0), Week 1, Week 2, and Week 4

• Change in Skin Hydration

  Skin hydration measured using a Corneometer on each treated side at each visit.

  Baseline (Week 0), Week 1, Week 2, and Week 4

Secondary Outcomes (7)

• Change in Clinical Dryness and Pruritus Score

  Baseline (Week 0), Week 1, Week 2, and Week 4

• Change in Investigator's Global Assessment (IGA) Score

  Baseline (Week 0), Week 1, Week 2, and Week 4

• Change in Skin Surface pH

  Baseline (Week 0), Week 1, Week 2, and Week 4

• Change in Dermatology Life Quality Index (DLQI) Score

  Week 1, Week 2, and Week 4 (not assessed at baseline)

• Change in Children's Dermatology Life Quality Index (CDLQI) Score

  Week 1, Week 2, and Week 4

Study Arms (2)

Cholesterol Cream Side

EXPERIMENTAL

The body area randomized to receive topical 10% cholesterol cream, applied twice daily to a designated skin site for the duration of the treatment period. This arm represents one side of the within-participant, split-body comparison, in which each participant simultaneously receives 10% cholesterol cream on one body area and 10% urea cream on the contralateral, anatomically matched area. Outcomes assessed on this side include transepidermal water loss (TEWL), skin hydration, skin surface pH, clinical dryness and pruritus severity, and standardized clinical photography.

Drug: 10% Cholesterol Cream

Urea Cream Side

ACTIVE COMPARATOR

The contralateral, anatomically matched body area randomized to receive topical 10% urea cream, applied twice daily for the duration of the treatment period, serving as the active comparator. This arm represents the other side of the within-participant, split-body comparison, in which each participant simultaneously receives 10% urea cream on this body area and 10% cholesterol cream on the corresponding area on the opposite side. Outcomes assessed on this side include transepidermal water loss (TEWL), skin hydration, skin surface pH, clinical dryness and pruritus severity, and standardized clinical photography, allowing direct within-participant comparison against the cholesterol cream side.

Drug: 10% Urea cream

Interventions

10% Cholesterol Cream DRUG

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.

Cholesterol Cream Side

10% Urea cream DRUG

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

Urea Cream Side

Eligibility Criteria

• Age: 7 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Receiving care at the Institute of Dermatology
• Willing and able to provide informed consent (or, for participants under 18, assent with parental/legal guardian consent)

You may not qualify if:

• 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
• Pregnant (confirmed by positive urine pregnancy test), breastfeeding, or planning pregnancy during the study period

Sponsors & Collaborators

• Institute of Dermatology, Thailand: lead

Study Sites (1)

Institute of dermatology

Bangkok, Bangkok, 10330, Thailand

Location

Central Study Contacts

Chavalit Supsrisunjai, MD, PhD

CONTACT

+66825614441; chervilius@gmail.com

Aporn Bureethan, B.Sc.

CONTACT

+6622354803; apornb@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a within-participant, split-body (intraindividual) comparison rather than a sequential crossover. Each participant receives both interventions concurrently: 10% cholesterol cream is applied to a designated body area, and 10% urea cream is applied to the contralateral, anatomically matched area, on the same participant at the same time. There is no treatment sequence, washout period, or randomized ordering over time; randomization instead determines which side of the body receives which cream. This design was chosen because ARCI is rare and clinically heterogeneous between individuals, making within-person comparison more efficient and statistically powerful than a between-group design.

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 8, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)