Phase 3 Sleep Disorders Trial, Recruiting NCT07245238 Sponsor: Khon Kaen University Condition: Sleep Disorders
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Phase 3 Sleep Disorders Trial, Recruiting

NCT07245238
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with systemic sclerosis (SSc) and are between 18 and 70 years old
  • People whose SSc was diagnosed using the internationally recognised 2013 ACR/EULAR classification criteria
  • People who have long-lasting, persistent itching (chronic pruritus)
  • People who are either not taking steroids, or are taking a low dose (no more than the equivalent of 10 mg per day of prednisolone)
  • People who have been on a stable, unchanged dose of steroids, immune-suppressing medications, and/or vitamins or supplements for at least 2 weeks before joining the trial
  • People who have stopped using moisturiser treatments at least 1 week before the trial's randomisation stage
  • People who have stopped taking anti-anxiety medications, sleeping tablets, or hypnotic medications at least 2 weeks before joining the trial
  • People who can read and write in the Thai language

Who may not be able to join:

  • People whose SSc overlaps with another connective tissue disease
  • People who are pregnant or currently breastfeeding
  • People who are bedridden and unable to perform any self-care
  • People who have an active cancer or malignant disease
  • People who have poorly controlled or severe health conditions, including diabetes, asthma, angina, heart or cardiovascular disease, thyroid disease, liver or bile duct disease (including cholestasis), or kidney disease with elevated creatinine levels (confirm with trial site)
  • People who have an active infection currently requiring antibiotic treatment taken throughout the body (systemic antibiotics)
  • People who have had a previous allergic reaction to urea cream, cannabinoids, or related substances
  • People who are currently using illegal drugs such as amphetamines or cocaine
  • People who are currently taking anti-anxiety medications, sleeping tablets, or hypnotic medications
  • People whose immune-suppressing medication dose currently needs to be adjusted
  • People with a history of schizophrenia, or a currently active mood disorder or anxiety disorder
  • People who have a skin condition that itself causes itching, such as eczema, psoriasis, scabies, or other listed skin diseases (confirm with trial site for the full list)
  • People who have another medical condition — separate from SSc — that is known to cause itching, such as certain neurological diseases or polycythemia vera

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 6643363746

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Khon Kaen University
Registry
ClinicalTrials.gov
Start date
5 November 2025
Est. completion
1 December 2027

Where this trial is recruiting

🇹🇭 Thailand

Primary endpoints

The changing of intensity of pruritus evaluated by visual analogue scale (VAS) compared to baseline and a comparison between treatment and control group

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov