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NCT01318733
A Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of CD07805/47 Gel 0.5% Applied Topically Once Daily for up to 52 Weeks in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea
Phase 3 trial testing CD07805/47 gel 0.5% in Rosacea in 449 participants. Completed in 1 July 2012.
1 June 2012
Quick facts
| Lead sponsor | Galderma R&D |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 449 |
| Start date | 1 March 2011 |
| Primary completion | 1 June 2012 |
| Estimated completion | 1 July 2012 |
| Sites | 27 locations across United States |
Drugs / interventions tested
- CD07805/47 gel 0.5% — full drug profile →
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.
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Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.
Time frame: Over 1 year
Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema 1. / Almost clear; slight redness 2. / Mild erythema; definite redness 3. / Moderate erythema; marked redness 4. / Severe erythema; fiery redness Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including
Sponsor's own description
A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01318733
- 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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- NCT06312813 — Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With · Phase 2 · recruiting
- NCT06072066 — Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammatio · NA · recruiting
- NCT05942248 — The Use of Image-Based Computer Gradings in the Analysis of Acne, Rosacea, Melasma, and Seborrheic Dermatitis · NA · recruiting
- NCT05928169 — Determinants of Chronic Inflammatory Skin Disease Trajectories · recruiting
Other Galderma R&D trials
Trials by the same sponsor.
- NCT07047690 — A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis · Phase 2 · recruiting
- NCT07344584 — A Prospective Pilot Study to Evaluate Safety and Effectiveness of GP0122 and GP0124 for Correction of Lines and Wrinkles · NA · not yet recruiting
- 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 NCT01318733 (US National Library of Medicine, public domain)
- 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/NCT01318733.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing