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NCT01355471
A Multicenter, Randomized Double-Blind, Vehicle-Controlled, Parallel Group Study to Demonstrate the Efficacy and Safety of CD07805/47 Gel Applied Topically Once Daily in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea
Phase 3 trial testing CD07805/47 Gel in Rosacea in 293 participants. Completed in 1 January 2012.
1 November 2011
Quick facts
| Lead sponsor | Galderma R&D |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 293 |
| Start date | 1 May 2011 |
| Primary completion | 1 November 2011 |
| Estimated completion | 1 January 2012 |
| Sites | 15 locations across United States, Canada |
Drugs / interventions tested
- CD07805/47 Gel — full drug profile →
- Placebo
Conditions studied
- Rosacea — all drugs for Rosacea →
Sponsor
Galderma R&D — full company profile →
Who can join
18 and older, any sex, with Rosacea. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Composite Success
Time frame: Day 29
Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).
Sponsor's own description
This is a Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Interventions for rosacea.
van Zuuren EJ, Fedorowicz Z, Carter B, van der Linden MM, et al · · 2015 · cited 59× · PMID 25919144 · DOI 10.1002/14651858.cd003262.pub5
Verify or expand the search:
- PubMed search for NCT01355471
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Rosacea
Currently open trials in the same condition.
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Other Galderma R&D trials
Trials by the same sponsor.
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- NCT07186413 — A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne · Phase 3 · recruiting
- NCT07398989 — A Clinical Study to Assess Efficacy and Tolerability of a Topical Skincare Product on Adults With Mature, Crepey Skin · Phase 4 · completed
- NCT06988618 — Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01355471 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Galderma R&D
- Last refreshed: 16 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01355471.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing