Schedule of observations
| Outcome measure | 6 weeks | 12 weeks (primary endpoint) | 24 weeks (end of treatment) | Unblinded follow-up (52 weeks or sooner)‡‡ |
| Primary outcome measure | ||||
| Acne-QoL symptom subscale score | X | |||
| Secondary outcome measures | ||||
| Acne-QoL symptom subscale score | X | X | X | X |
| Acne-QoL other subscales | X | X | X | X |
| Acne-QoL total score* | X | X | X | X |
| Participant self-assessed overall improvement† | X | X | X | X |
| IGA‡ | X | X | ||
| Participant’s Global Assessment§ | X | X | X | X |
| Participant satisfaction with study treatment¶ | X | |||
| Health-related quality of life using EQ-5D-5L** | X | X | X | X |
| Costs incurred | X | X | X | X |
| Cost-effectiveness†† | X | |||
*Self-perception, role—emotional and role—social.
†Recorded on a 6-point Likert Scale with photographs taken at the baseline visit to aid recall.37
‡5-point scale ranging from clear to severe (0, clear; 1, almost clear; 2, mild; 3, moderate; 4, severe).25
§Same scale as the IGA but written in plain English for participants’ use.
¶Asked prior to revealing treatment allocation after 24 weeks.
**The EQ-5D-5 L assesses five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
††Using EQ-5D-5L and data on health resource use during the study.
‡‡The follow-up questionnaire will be sent out 6 months or sooner after the 24-week time point.
IGA, Investigator’s Global Assessment.