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Placebo + TCS
This is a control arm combining placebo with topical corticosteroid (TCS) therapy, used as a comparator in clinical trials to establish efficacy of an investigational treatment.
This is a control arm combining placebo with topical corticosteroid (TCS) therapy, used as a comparator in clinical trials to establish efficacy of an investigational treatment. Used for Control arm in phase 3 dermatological trials (specific indication unknown).
At a glance
| Generic name | Placebo + TCS |
|---|---|
| Sponsor | LEO Pharma |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
Placebo + TCS serves as the active control arm in phase 3 trials, where topical corticosteroids provide standard-of-care anti-inflammatory and immunosuppressive effects on skin conditions. The placebo component allows for blinding while TCS delivers the established therapeutic benefit expected from conventional treatment, enabling comparison of the investigational drug against this baseline.
Approved indications
- Control arm in phase 3 dermatological trials (specific indication unknown)
Common side effects
- Skin atrophy
- Striae
- Telangiectasia
- Local irritation
Key clinical trials
- A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis (PHASE3)
- Targeted Investigation of Microbiome 2 Treat Atopic Dermatitis (TIME-2) (PHASE1)
- Safety and Efficacy of Upadacitinib in Combination With Topical Corticosteroids in Children From 2 to Less Than 12 Years of Age in Japan With Moderate to Severe Atopic Dermatitis (PHASE3)
- A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis (PHASE3)
- A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD) (PHASE3)
- A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (PHASE3)
- A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD) (PHASE3)
- A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |