Acne Skin and Connective Tissue Diseases
Conditions
Interventions
This trial is a comparison of two dosing strategies.
Low-dose strategy (intervention):
Oral isotretinoin 0.25 mg/kg/day (within a range of 0.2-0.3 mg/kg/day). At 6 months, if there has been insuffici
this is a shared decision between the participant and a health professional or
2. A maximum cumulative dose of 150 mg/kg is reached or
3. A total of 12 months duration on the medication or
4. A part
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Age
12 Years to 24 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 22/08/2025: 1. Age 12 years to 24 years. 2. Acne of the face +/- trunk. 3. Meets the MHRA definition of severe forms of acne (including acne at risk of permanent scarring). 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 _____ Previous inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: 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 2. A maximum cumulative dose of 150 mg/kg is reached or 3. A total of 12 months duration on the medication (whichever happens sooner) or 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
| Measure | Time frame |
|---|---|
| 1. Blinded investigator assessed acne severity, assessed using Investigator Global Assessment (IGA) using the Comprehensive Acne Severity Scale (CASS) at baseline,1, 3, 5-6, 8-10 months and end of treatment 2. Time to treatment success (clearance of acne) defined as “clear or almost clear” using the Comprehensive Acne Severity Scale (CASS) at the end of their treatment course. 3. Patient-reported acne severity assessed using the Patient Global Assessment (PGA) - baseline then monthly until end of treatment, and monthly in the follow-up phase 4. Patient-reported change in acne assessed using bespoke question at month 3 and end of treatment 5. Tolerability of side effects, assessed using the Modified British Association of Dermatologists side effect questionnaire – monthly until the end of treatment, then 1 month and 12 months in the follow-up phase 6. Acne health related quality of life assessed using the Acne Specific Quality of Life Questionnaire (Acne-QoL) at baseline, 3, 6, 9 months and end of treatment course 7. Patient satisfaction with treatment assessed using the Treatment Satisfaction Questionnaire for Medicine (TSQM) at month 3 and end of treatment course 8. Referral for a mental health assessment and/or cessation of isotretinoin due to concerns with mood, collected from medical notes at 1, 3, 5-6, 8-10 months and end of treatment course, or at any other time in the active treatment phase 9. Referral for a mental health assessment and/or dose reduction of isotretinoin, collected from medical notes, at 1, 3, 5-6, 8-10 months and end of treatment course, or at any other time in the active treatment phase 10. Patient-reported depression score assessed using Patient Health Questionnaire (PHQ-9/9a) monthly until the end of treatment and 1 month after stopping treatment 11. Patient-reported anxiety score assessed using the General Anxiety Disorder (GAD-7) questionnaire monthly until the end of treatment and 1 month after stopping treatment 12. Recurrence in acne | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed