NCT01318733CompletedPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Galderma R&D
- Enrollment
- 449
- Locations
- 27
- Primary Endpoint
- Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female who is at least 18 years of age or older.
- •A clinical diagnosis of facial rosacea.
- •A Clinician Erythema Assessment (CEA) score of ≥3 at Screening and at Baseline (prior to study drug application).
- •A Patient Self Assessment (PSA) score of ≥3 at Screening and at Baseline (prior to study drug application).
Exclusion Criteria
- •Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
- •Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
- •Previous refractive eye surgery such as photorefractive keratectomy (PRK), laser-assisted sub-epithelial keratectomy (LASEK), or laser-assisted in situ keratomileusis (LASIK).
- •Current treatment with monoamine oxidase (MAO) inhibitors.
- •Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists.
- •Less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents.
Arms & Interventions
CD07805/47 Gel 0.5%
Experimental
Intervention: CD07805/47 gel 0.5% (Drug)
Outcomes
Primary Outcomes
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 Day 1.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (27)
Loading locations...
Similar Trials
Recruiting
Phase 1
CD7-specific CAR-T Cell in the Treatment of CD7-positive Relapsed/Refractory Hematologic TumorsHematologic MalignancyNCT06720324Wuhan Union Hospital, China80
Completed
Phase 3
A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)Actinic KeratosisNCT00917306Peplin102
Completed
Phase 4
Tofogliflozin GLP-1 Analogue Combination TrialType 2 Diabetes MellitusNCT02537834Kowa Company, Ltd.65
Terminated
Phase 1
Open-label Extension (OLE) Study of WVE-004 in Patients With C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) and/or Frontotemporal Dementia (FTD)ALSFTDFrontotemporal DementiaAmyotrophic Lateral SclerosisNCT05683860Wave Life Sciences USA, Inc.8
Completed
Phase 1
Long-term Safety of Alpha1-Proteinase Inhibitor (Human) in Japanese Subjects With Alpha1 Antitrypsin Deficiency (GTI1401-OLE)Alpha1-Antitrypsin DeficiencyNCT02870348Grifols Therapeutics LLC4