Brittle NailsPhase 4NCT00648986
Efficacy and Safety Study of Tazarotene (Tazorac) for the Treatment of Brittle Nails
A Phase 4 study testing Tazorac in people with Brittle Nails, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether topical tazarotene (Tazorac), a receptor-selective synthetic retinoid that normalizes epidermal differentiation, ameliorates signs and symptoms of brittle nails. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Brittle Nails
- What is being tested?
- Tazorac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has provided IRB-approved written informed consent prior to conducting any study-related procedures
- Men and female patients 18 to 75 years of age
- Have had a diagnosis of brittle nails
- Have two target fingernails identified at baseline
- Have evidence of at least two of the following signs and symptoms of brittle nails in each of the selected nail plates or severe signs (one or more) on each target nail:
- trachyonychia (surface roughness)
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- lamellar onychoschizia (horizontal layering)
- longitudinal cracking or splitting of the distal edge
- Female patient of childbearing potential (not surgically sterile or at least 2 years postmenopausal) has a negative pregnancy test at baseline/day 1 and is not lactating
- Sexually active female subject who is not surgically sterile or 2 years post menopausal must agree to use contraception/birth control measure while on study (e.g., oral contraceptives, diaphragms with spermicide, condoms with spermicide, intrauterine devices, Norplant System, Depo-Provera, tubal ligation)
- Patients will agree to self-administer topical study medication, and will agree to complete all study procedures
- Patient is judged to be in good health by medical history and physical examination
- Must be able to adhere to the study visit schedule and other protocol requirements
Who cannot join
- Have a history of surgery of the affected fingernails
- Are pregnant, nursing, or planning pregnancy prior to study enrollment
- Have a disturbance of the shape of the affected fingernails (e.g., due to malformation of the underlying bone) that would interfere with the investigator's ability to evaluate photographs
- Have onycholysis (lifting of the nail plate off the nailbed) of the affected fingernails
- Have a fungal infection of the affected fingernails
- Have a history of psoriasis or lichen planus involving any nail, or active contact dermatitis involving the affected fingernails
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- Have used any topical cosmetics or medicated products on the affected nails within 2 weeks of baseline visit
- Have received oral antifungal treatment within 3 months of baseline visit
- Have a known or suspected history of a genetic condition affecting the nails (e.g., Darier's disease, nail-patella syndrome, tuberculosis sclerosis)
- Immune compromise due to HIV infection, organ transplantation, or treatment of malignancy
- Chronic liver, heart, kidney, or ( untreated) thyroid disease
- Have used any investigational drug within the previous 1 month or 5 half-lives of the investigational agent, whichever is longer, or 3 months for any biologic of unknown half-life
- Are known to have had a substance abuse (drug or alcohol) problem within the previous 3 years
- Unlikely to comply with the study protocol and prescribed treatment or is unsuitable for any other reason in the opinion of the investigator
- Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease;
- Currently have any known malignancy or have a history of malignancy other than non-melanoma skin cancer
- Are known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- Have signs of bacterial, fungal or viral skin lesions that may interfere with measurement of the target lesions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Single Center, Open-Label, Efficacy and Safety Study of Tazarotene (Tazorac) for the Treatment of Brittle Nails
The purpose of this study is to determine whether topical tazarotene (Tazorac), a receptor-selective synthetic retinoid that normalizes epidermal differentiation, ameliorates signs and symptoms of brittle nails.
Read the detailed description
"Brittle nails," referring to nails that chip, peel, or split excessively, occur in up to 30% of women and 15% of men, with highest prevalence among the elderly. Treatment of brittle nails involves restoration and maintenance of a normal degree of nail plate hydration by minimizing exposure to dehydrating chemicals and by use of moisturizers, such as alpha-hydroxy acids. Retinoids are vitamin A analogs that play a role in skin cell differentiation and proliferation. Tazarotene is a topical receptor-selective synthetic retinoid that normalizes epidermal differentiation and reduces the influx of inflammatory cells into the skin. In this single-center, open-label trial, subjects applied tazarotene to the nails twice daily for 24 weeks. Signs and symptoms were rated by the investigators and subjects during treatment and 12 weeks after discontinuation.
- Conditions
- Brittle Nails
- Being tested
- Tazorac
- Keywords
- brittle nails, Tazarotene, Tazorac
- Medical subject headings
- Twenty-Nail Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TazoracDrug
Also called Tazarotene
All patients were to apply topical tazarotene (Tazorac) twice daily to all affected fingernails for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Uncontrolled, Open-Label Pilot Study Receives: Drug: Tazorac |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint was the change in the Physician's Global Improvement Assessment (PGIA) of the 2 target nails. The PGIA score reflects the comparison of photographs taken at baseline to the nails at 12 weeks, 24 weeks, and 36 weeks.
Measured: Weeks 12, 24, and 36
Secondary outcomes (5)
Physician's Global Assessment (PGA) measures the severity of brittle nail symptoms.
Measured: Baseline, Week 12, and Week 24
Physician ratings of the roughness, raggedness, and peeling of the target nails.
Measured: All study visits
A VapoMeter measures the Transonychial Water Loss (TOWL) on both target nails.
Measured: All study visits
Subject reporting provides the subjects' assessments of their nail breakage.
Measured: All study visits
Subject reporting provides the subjects' satisfaction with the product.
Measured: Week 12, 24, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startAug 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brittle NailsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Investigators
- Richard Scher, MD, Principal investigator, University of North CarolinaJulian Mackay-Wiggan, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648986
- Sponsor's protocol ID
- AAAA5735
- Other IDs
- TAZ11-2003
- Status last verified
- Jun 2014
- First submitted
- 27 Mar 2008
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Open-Label, Efficacy and Safety Study of Tazarotene (Tazorac) for the Treatment of Brittle Nails
- ClinicalTrials.gov ID
- NCT00648986
- Acronym / sponsor ID
- AAAA5735
- Conditions
- Brittle Nails
- Keywords
- brittle nails, Tazarotene, Tazorac
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Aug 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether topical tazarotene (Tazorac), a receptor-selective synthetic retinoid that normalizes epidermal differentiation, ameliorates signs and symptoms of brittle nails.
Detailed description
"Brittle nails," referring to nails that chip, peel, or split excessively, occur in up to 30% of women and 15% of men, with highest prevalence among the elderly. Treatment of brittle nails involves restoration and maintenance of a normal degree of nail plate hydration by minimizing exposure to dehydrating chemicals and by use of moisturizers, such as alpha-hydroxy acids. Retinoids are vitamin A analogs that play a role in skin cell differentiation and proliferation. Tazarotene is a topical receptor-selective synthetic retinoid that normalizes epidermal differentiation and reduces the influx of inflammatory cells into the skin. In this single-center, open-label trial, subjects applied tazarotene to the nails twice daily for 24 weeks. Signs and symptoms were rated by the investigators and subjects during treatment and 12 weeks after discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TazoracUncontrolled, Open-Label Pilot Study |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient has provided IRB-approved written informed consent prior to conducting any study-related procedures
- Men and female patients 18 to 75 years of age
- Have had a diagnosis of brittle nails
- Have two target fingernails identified at baseline
- Have evidence of at least two of the following signs and symptoms of brittle nails in each of the selected nail plates or severe signs (one or more) on each target nail:
Key exclusion criteria (18 listed)
- Have a history of surgery of the affected fingernails
- Are pregnant, nursing, or planning pregnancy prior to study enrollment
- Have a disturbance of the shape of the affected fingernails (e.g., due to malformation of the underlying bone) that would interfere with the investigator's ability to evaluate photographs
- Have onycholysis (lifting of the nail plate off the nailbed) of the affected fingernails
- Have a fungal infection of the affected fingernails
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TazoracAlso: TazaroteneAll patients were to apply topical tazarotene (Tazorac) twice daily to all affected fingernails for 24 weeks. | Drug | 1 |
Primary outcome
The primary endpoint was the change in the Physician's Global Improvement Assessment (PGIA) of the 2 target nails. The PGIA score reflects the comparison of photographs taken at baseline to the nails at 12 weeks, 24 weeks, and 36 weeks.
Time frame: Weeks 12, 24, and 36
5 secondary outcomes
Physician's Global Assessment (PGA) measures the severity of brittle nail symptoms.
Time frame: Baseline, Week 12, and Week 24
Physician ratings of the roughness, raggedness, and peeling of the target nails.
Time frame: All study visits
A VapoMeter measures the Transonychial Water Loss (TOWL) on both target nails.
Time frame: All study visits
Subject reporting provides the subjects' assessments of their nail breakage.
Time frame: All study visits
Subject reporting provides the subjects' satisfaction with the product.
Time frame: Week 12, 24, and 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Scher, MD principal investigator
University of North Carolina
Julian Mackay-Wiggan, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tazorac in people with Brittle Nails, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint was the change in the Physician's Global Improvement Assessment (PGIA) of the 2 target nails. The PGIA score reflects the comparison of photographs taken at baseline to the nails at 12 weeks, 24 weeks, and 36 weeks. (time frame: Weeks 12, 24, and 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2014.