Autosomal Recessive Congenital IchthyosisCURE-ARCINCT07689435
Cholesterol Cream vs Urea Cream for Skin Barrier and Quality of Life in Ichthyosis
A study testing 10% Cholesterol Cream and 10% Urea cream in people with Autosomal Recessive Congenital Ichthyosis and Skin Barrier Dysfunction, run by Institute of Dermatology, Thailand at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 65 years
- Conditions the study is for
- Autosomal Recessive Congenital Ichthyosis, Skin Barrier Dysfunction, Ichthyosis Inherited
- What is being tested?
- 10% Cholesterol Cream and 10% Urea cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- 15 Jul 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Institute of dermatology
Bangkok, Bangkok, 10330
Aporn Bureethan, B.Sc., +6695-207-2811, apornb@hotmail.com
About this study
Official title: A Comparative Study on the Efficacy of 10% Cholesterol Cream Versus 10% Urea Cream in Improving Skin Barrier Function and Quality of Life in Patients With Autosomal Recessive Congenital Ichthyosis
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.
Read more
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.
Read the detailed description
Autosomal recessive congenital ichthyosis (ARCI) is a rare group of inherited skin disorders caused by mutations in genes required for normal lipid metabolism and barrier lipid assembly in the stratum corneum. The resulting epidermal barrier dysfunction produces generalized dryness, scaling, elevated transepidermal water loss (TEWL), chronic pruritus, and an increased susceptibility to skin infection. These manifestations begin at or shortly after birth and persist throughout life, with substantial negative effects on physical comfort, sleep, social functioning, and psychological well-being, particularly in children.
Current standard care relies on humectant and keratolytic agents such as 10% urea cream, which improve hydration and assist desquamation but do not address the underlying lipid deficiency responsible for barrier impairment. Cholesterol is a principal lipid component of the lamellar lipid matrix that cements corneocytes together within the stratum corneum. Exogenous application of cholesterol has been proposed as a mechanism-based intervention capable of correcting the disordered lipid lamellae characteristic of ARCI, thereby improving barrier integrity and reducing transepidermal water loss. Prior open-label, half-side comparison work in recessive X-linked ichthyosis demonstrated favorable clinical responses to topical cholesterol compared with urea, although that work did not include objective barrier measurements such as TEWL or validated quality-of-life instruments. Combination cholesterol-lovastatin preparations have also shown reductions in disease severity in ARCI. To date, no study has directly compared 10% cholesterol cream with 10% urea cream in patients with ARCI using both physiological barrier measurements and quality-of-life outcomes.
This investigation uses a prospective, randomized, split-body (intraindividual, half-side) comparison design, in which each participant serves as their own control: one cream is applied to a designated body area while the comparator cream is applied to the contralateral, matched area. This design was selected because ARCI is rare and clinically heterogeneous between individuals, making between-subject comparison less efficient than a within-subject comparison.
The primary objective is to compare the efficacy of 10% cholesterol cream and 10% urea cream in restoring skin barrier function, assessed by TEWL and skin hydration. Secondary objectives include comparison of clinical dryness and pruritus severity, changes in skin surface pH, assessment of quality of life using the Dermatology Life Quality Index (DLQI) or, for pediatric participants, the Children's Dermatology Life Quality Index (CDLQI), evaluation of participant satisfaction with each cream, and documentation of clinical change through standardized clinical photography.
Sample size was calculated using a two-dependent-means (paired t-test) formula based on an expected TEWL difference of 4 g/m²/h between treatments, a standard deviation of 6 g/m²/h, a two-sided significance level of 0.05, and 80% power, yielding a minimum requirement of 18 evaluable participants. To allow for an anticipated dropout or missing-data rate of 25%, the target enrollment was set at 24 participants.
This single-center study is being conducted at the Institute of Dermatology, Bangkok, Thailand, and has received approval from the Institute's Ethics Committee
- Being tested
- 10% Cholesterol Cream, 10% Urea cream
- Keywords
- Autosomal Recessive Congenital Ichthyosis, Cholesterol Cream, Urea Cream, Skin Barrier Function, Dermatology Life Quality Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% Cholesterol CreamDrug
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.
10% Urea creamDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 10% Urea cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Week 0), Week 1, Week 2, and Week 4
Secondary outcomes (7)
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.
Measured: Baseline (Week 0), Week 1, Week 2, and Week 4
Change in Investigator's Global Assessment (IGA) Score
Investigator-rated overall disease severity score assessed on each treated side at each visit.
Measured: Baseline (Week 0), Week 1, Week 2, and Week 4
Change in Skin Surface pH
Skin surface pH measured with a skin pH meter on each treated side at each visit.
Measured: Baseline (Week 0), Week 1, Week 2, and Week 4
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.
Measured: Week 1, Week 2, and Week 4 (not assessed at baseline)
Change in Children's Dermatology Life Quality Index (CDLQI) Score
The Children's Dermatology Life Quality Index (CDLQI) is a 10-item validated questionnaire assessing the impact of skin disease on quality of life in pediatric patients aged 7-17 years 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.
Measured: Week 1, Week 2, and Week 4
Mean Satisfaction Score With 10% Cholesterol Cream and 10% Urea Cream Assessed by Likert Scale Questionnaire
Participant-reported satisfaction with each study cream (10% cholesterol cream and 10% urea cream) assessed separately at Week 4 using a study-specific Likert scale satisfaction questionnaire. Results are reported as mean and standard deviation (SD) for each cream and compared between the two products. Higher scores indicate greater satisfaction.
Measured: Week 4 only
Number of Participants With Clinical Improvement on Standardized Photography as Assessed by Blinded Investigator Review
Standardized digital clinical photographs of each treated side (cholesterol cream side versus urea cream side) are taken at each visit. Photographs are reviewed by a blinded investigator and compared against baseline images (Week 0) to assess clinical improvement in skin appearance. The number of participants showing clinical improvement on each treated side is reported at each time point.
Measured: Baseline (Week 0), Week 1, Week 2, and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Recessive Congenital IchthyosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Dermatology, Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689435
- Sponsor's protocol ID
- IRB/IEC No. 021/2568
- Acronym
- CURE-ARCI
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on the Efficacy of 10% Cholesterol Cream Versus 10% Urea Cream in Improving Skin Barrier Function and Quality of Life in Patients With Autosomal Recessive Congenital Ichthyosis
- ClinicalTrials.gov ID
- NCT07689435
- Acronym / sponsor ID
- CURE-ARCI / IRB/IEC No. 021/2568
- Keywords
- Autosomal Recessive Congenital Ichthyosis, Cholesterol Cream, Urea Cream, Skin Barrier Function, Dermatology Life Quality Index
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Institute of Dermatology, ThailandOther government
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Autosomal recessive congenital ichthyosis (ARCI) is a rare group of inherited skin disorders caused by mutations in genes required for normal lipid metabolism and barrier lipid assembly in the stratum corneum. The resulting epidermal barrier dysfunction produces generalized dryness, scaling, elevated transepidermal water loss (TEWL), chronic pruritus, and an increased susceptibility to skin infection. These manifestations begin at or shortly after birth and persist throughout life, with substantial negative effects on physical comfort, sleep, social functioning, and psychological well-being, particularly in children.
Current standard care relies on humectant and keratolytic agents such as 10% urea cream, which improve hydration and assist desquamation but do not address the underlying lipid deficiency responsible for barrier impairment. Cholesterol is a principal lipid component of the lamellar lipid matrix that cements corneocytes together within the stratum corneum. Exogenous application of cholesterol has been proposed as a mechanism-based intervention capable of correcting the disordered lipid lamellae characteristic of ARCI, thereby improving barrier integrity and reducing transepidermal water loss. Prior open-label, half-side comparison work in recessive X-linked ichthyosis demonstrated favorable clinical responses to topical cholesterol compared with urea, although that work did not include objective barrier measurements such as TEWL or validated quality-of-life instruments. Combination cholesterol-lovastatin preparations have also shown reductions in disease severity in ARCI. To date, no study has directly compared 10% cholesterol cream with 10% urea cream in patients with ARCI using both physiological barrier measurements and quality-of-life outcomes.
This investigation uses a prospective, randomized, split-body (intraindividual, half-side) comparison design, in which each participant serves as their own control: one cream is applied to a designated body area while the comparator cream is applied to the contralateral, matched area. This design was selected because ARCI is rare and clinically heterogeneous between individuals, making between-subject comparison less efficient than a within-subject comparison.
The primary objective is to compare the efficacy of 10% cholesterol cream and 10% urea cream in restoring skin barrier function, assessed by TEWL and skin hydration. Secondary objectives include comparison of clinical dryness and pruritus severity, changes in skin surface pH, assessment of quality of life using the Dermatology Life Quality Index (DLQI) or, for pediatric participants, the Children's Dermatology Life Quality Index (CDLQI), evaluation of participant satisfaction with each cream, and documentation of clinical change through standardized clinical photography.
Sample size was calculated using a two-dependent-means (paired t-test) formula based on an expected TEWL difference of 4 g/m²/h between treatments, a standard deviation of 6 g/m²/h, a two-sided significance level of 0.05, and 80% power, yielding a minimum requirement of 18 evaluable participants. To allow for an anticipated dropout or missing-data rate of 25%, the target enrollment was set at 24 participants.
This single-center study is being conducted at the Institute of Dermatology, Bangkok, Thailand, and has received approval from the Institute's Ethics Committee
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cholesterol Cream Side | Experimental | Drug: 10% Cholesterol CreamThe 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. |
| Urea Cream Side | Active comparator | Drug: 10% Urea creamThe 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. |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% Cholesterol CreamA 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 | Cholesterol Cream Side |
| 10% Urea creamA 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 | Drug | Urea Cream Side |
Primary outcome
Change in Transepidermal Water Loss (TEWL)
Time frame: Baseline (Week 0), Week 1, Week 2, and Week 4
TEWL measured using a Tewameter on the cholesterol cream-treated side versus the urea cream-treated side at each visit.
Change in Skin Hydration
Time frame: Baseline (Week 0), Week 1, Week 2, and Week 4
Skin hydration measured using a Corneometer on each treated side at each visit.
7 secondary outcomes
Change in Clinical Dryness and Pruritus Score
Time frame: Baseline (Week 0), Week 1, Week 2, and Week 4
Change in Investigator's Global Assessment (IGA) Score
Time frame: Baseline (Week 0), Week 1, Week 2, and Week 4
Change in Skin Surface pH
Time frame: Baseline (Week 0), Week 1, Week 2, and Week 4
Change in Dermatology Life Quality Index (DLQI) Score
Time frame: Week 1, Week 2, and Week 4 (not assessed at baseline)
Change in Children's Dermatology Life Quality Index (CDLQI) Score
Time frame: Week 1, Week 2, and Week 4
Mean Satisfaction Score With 10% Cholesterol Cream and 10% Urea Cream Assessed by Likert Scale Questionnaire
Time frame: Week 4 only
Number of Participants With Clinical Improvement on Standardized Photography as Assessed by Blinded Investigator Review
Time frame: Baseline (Week 0), Week 1, Week 2, and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10% Cholesterol Cream and 10% Urea cream in people with Autosomal Recessive Congenital Ichthyosis and Skin Barrier Dysfunction, run by Institute of Dermatology, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chavalit Supsrisunjai, MD, PhD (+66825614441, chervilius@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Transepidermal Water Loss (TEWL) (time frame: Baseline (Week 0), Week 1, Week 2, and Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.