ow-dose isotretinoin versus standard-dose isotretinoin to treat severe acne in young people – the Acne-ID study
- Conditions
- AcneSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN45540647
- Lead Sponsor
- niversity of Nottingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 800
1. Clinical diagnosis of severe acne (including acne at risk of scarring) of the face +/- trunk
2. Acne that has failed to respond to at least one 12-week minimum course of oral antibiotics in combination with a topical treatment
3. Age =12 years to <25 years
4. Able to give consent or child assent with parental consent
5. Clinical decision to start treatment with oral isotretinoin
6. Medicines and Healthcare products Regulatory Agency (MHRA) risk acknowledgment form completed by the treating clinician
7. Willing to be randomised to either treatment group
8. Willing and able to complete the trial questionnaires
1. Contraindication to isotretinoin as per clinician assessment in routine care (e.g. severe mood concerns on screening, refusal to sign the Acknowledgement of Risk Form and enter the Pregnancy Prevention Programme if has childbearing potential (pregnant, or breastfeeding or Intention to become pregnant), concomitant medications with an interaction with isotretinoin)
2. Acne fulminans, acne conglobata or other acne subtype unsuitable for higher dose strategy
3. Previously been treated with oral isotretinoin
4. Known allergy or sensitivity to isotretinoin or any of its excipients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of participants achieving clearance of acne, defined as clear or almost clear” at the end of their treatment course. Treatment success (clearance of acne) is defined as ‘clear or almost clear’, assessed using a blinded Investigator Global Assessment (IGA) using the Comprehensive Acne Severity Scale (CASS). The end of the active treatment period is defined as: <br>1. When participants have no new inflammatory lesions for a minimum of 4 weeks; this is a shared decision between the participant and a health professional or<br>2. A maximum cumulative dose of 150 mg/kg is reached or <br>3. A total of 12 months duration on the medication (whichever happens sooner) or<br>4. A participant and/or clinician decision to stop isotretinoin even when there has not been a satisfactory outcome (e.g. because of side effects)
- Secondary Outcome Measures
Name Time Method