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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02235480
Other study ID # H 573 000 1307
Secondary ID 2013-004519-28
Status Completed
Phase Phase 2
First received March 31, 2014
Last updated June 9, 2015
Start date February 2014
Est. completion date May 2015

Study information

Verified date June 2015
Source Almirall, S.A.
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine the efficacy and safety of topical application of the gel compared to placebo in nail psoriasis.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date May 2015
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Key inclusion criteria:

- Mild to moderate nail psoriasis on at least one fingernail

Exclusion Criteria:

Key exclusion criteria:

- any other skin condition, with a potential to affect the nails or to interfere with evaluation of the disease;

- history of hypersensitivity to retinoids or to other components of the trial medication

- topical treatment of nails with antipsoriatics in the 4 weeks preceding the treatment phase;

- systemic treatment of psoriasis within the three months before the treatment phase of the trial or during the trial

- intralesional steroid injection before the treatment phase of the trial

- phototherapy before the treatment phase of the trial;

- any chronic infection or condition capable of interfering with the conduct of the trial;

- evidence of drug or alcohol abuse;

- symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks preceding the treatment phase of the trial;

- participation in another clinical trial within the last 4 weeks prior to first treatment in this clinical trial;

- pregnancy or nursing;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Experimental Tazarotene Gel

Placebo


Locations

Country Name City State
Germany Investigational site 3 Berlin
Germany Investigational site 4 Berlin
Germany Investigational 2 Hamburg
Germany Investigational site 1 Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Almirall, S.A.

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary % reduction in the Nail Psoriasis Severity Index ( NAPSI ) Day85 No
Secondary Number of Participants with Adverse Events as a Measure of Safety and Tolerability Day 85 Yes
See also
  Status Clinical Trial Phase
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Completed NCT00999687 - Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails Phase 2/Phase 3
Completed NCT00581100 - Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis Phase 4
Completed NCT04580537 - Assessing the Efficacy of Image-guided Laser-assisted Enstilar® Delivery for Treatment of Psoriatic Nails Phase 2
Not yet recruiting NCT03263624 - Efficacy of Combined Fractional Carbon Dioxide Laser and Topical Tazarotene in the Treatment of Psoriatic Nail Disease Phase 4
Completed NCT02606760 - Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Nails Affected by Psoriasis Phase 3
Completed NCT04227288 - A Study Evaluating the Efficacy and Tolerability of Enstilar Foam in Patients With Nail Psoriasis Phase 4
Withdrawn NCT03079973 - Study to Evaluate the Efficacy and Safety of P-3073 Nail Solution in the Treatment of Mild to Moderate Psoriatic Fingernail/s Phase 3
Completed NCT04380597 - Observational Study in Patients With Nail Psoriasis Treated With Enstilar® to Assess the Severity Change and the Quality of Life
Completed NCT03991936 - Benefit of Placebo and Different Concentrations of Triamcinolone Acetonide in Nail Psoriasis Phase 4
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Completed NCT03757364 - Methotrexate in the Treatment of Distal Interphalangeal Joint Extensor Tendon Enthesopathy in Nail Psoriasis
Completed NCT02016482 - A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis Phase 3
Completed NCT02168933 - 308nm Excimer Laser for Treatment of Fingernail Psoriasis N/A
Completed NCT01445886 - Comparison of Indigo Naturalis Oil Extract and Calcipotriol Solution in Treating Psoriasis Phase 2/Phase 3
Not yet recruiting NCT05695833 - Nd:YAG Laser and Radiofrequency in Treatment of Fingernail Psoriasis N/A
Completed NCT03616561 - Quality of Life and Ultrasonographic Assessment of Nail Psoriasis After Treatment With Apremilast (JUST Study)
Not yet recruiting NCT06150794 - Methotrexate Alone vs Combination With Excimer Light in Nail Psoriasis N/A
Completed NCT03946826 - A Clinical Observation on the Efficacy and Safety of Pulsed Dye Laser (PDL) in the Treatment of Nail Psoriasis N/A
Active, not recruiting NCT05072886 - Study of Efficacy and Safety of Investigational Treatment in Patients With Nail Psoriasis Phase 1