Hand DermatosesPhase 2TAC-202NCT00890968
Safety and Efficacy Study of Triamcinolone Acetonide DuraPeel to Treat Hand Dermatitis
A Phase 2 study testing Triamcinolone Acetonide (TAC) DuraPeel in people with Hand Dermatoses, run by ZARS Pharma Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to determine whether Triamcinolone Acetonide (TAC) DuraPeel is safe and effective in the treatment of hand dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Dermatoses
- What is being tested?
- Triamcinolone Acetonide (TAC) DuraPeel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2009to Aug 2009
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of stable chronic hand dermatitis (greater than 6 weeks duration) that is KOH-negative
- Dermatitis of mild to moderate severity, as defined by an Investigator's Global Assessment (a score of 2 or 3 on the Target Hand)
- Individual signs of hand dermatitis disease of at least mild scaling and mild erythema (a score of 2 or more on the Target Hand)
- Written informed consent
Who cannot join
- Subject is female and is pregnant, lactating, or is planning to become pregnant during the study
- Spontaneously improving or rapidly deteriorating hand dermatitis at the time of enrollment; subject may have history of waxing and waning disease in the past
- History of hand dermatitis that has been shown to be unresponsive to super potent (Group 1) topical steroids
- Concurrent flaring of inflammatory skin disease (e.g., atopic dermatitis or psoriasis) anywhere on the body outside the study areas
- Bullous disorders or hand, foot, and mouth disease (HFMD); however, subjects with dyshidrotic hand dermatitis or pompholyx are allowed to participate provided they meet all other Inclusion/Exclusion criteria
- Known allergic mediated hand dermatitis (e.g., allergic to latex, etc.)
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- Concurrent skin diseases in the study area that require concomitant topical treatment (e.g., tinea manuum, scabies, infected eczema, and paronychia) that could interfere with the evaluation of his/her dermatitis
- Pustular diseases of the hands (e.g., acrodermatitis perstans continua).
- Used photo-therapy, photo-chemotherapy, systemic immunomodulatory therapy (such as systemic corticosteroids, methotrexate, retinoids or cyclosporine), or other therapy within 30 days prior to the first application of study medication that is known or suspected, in the opinion of the investigator, to have an effect on hand dermatitis
- Prolonged exposure to natural or artificial sources (e.g., UVB, UVA, etc.) of ultraviolet radiation within 30 days prior to the first application of study medication or is intending to have such exposure during the study
- Received intralesional therapy to the hands (e.g., corticosteroids) within 30 days prior to first application of study medication
- Treated with Grenz ray or soft x-ray therapy to the hands within 6 months of first application of study medication
- Treated with topical hand therapy (e.g., tar, topical corticosteroids, topical retinoids, topical antimicrobials, topical calcineurin inhibitors, Burrow's solution soaks) within 7 days prior to first application of study medication that is known or suspected to have an effect on hand dermatitis
- Received systemic antibiotics for infections of the hands within 7 days prior to the first application of study medication
Trial locations and contacts
3 sites in 1 country.
United States3 sites
DermResearch Inc.
Austin, Texas, 78759
Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038
Therapeutics Clinical Research
San Diego, California, 92123
About this study
Official title: A Multi-Center Randomized, Double-Blind, Placebo Controlled, Parallel Group Comparison Study of Once Daily Triamcinolone Acetonide 0.5% DuraPeel™ Versus Placebo DuraPeel in the Treatment of Hand Dermatitis
The purpose of this study is to determine whether Triamcinolone Acetonide (TAC) DuraPeel is safe and effective in the treatment of hand dermatitis.
Read the detailed description
Triamcinolone acetonide is a commonly used, safe, and effective topical corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. However, the effectiveness of topical agents such as creams or ointments is limited by patients' routine activities using bare hands that may remove the topical agent from the hands. The use of a topical corticosteroid in a vehicle that allows the product to remain in contact with the skin and is not susceptible to inadvertent removal would be beneficial.
The DuraPeel membrane is expected to optimize exposure to the steroid by remaining on the treatment area for a prolonged period of time.
This study is designed to evaluate the efficacy and safety of Triamcinolone Acetonide 0.5% DuraPeel. Eligible subjects will receive Triamcinolone Acetonide 0.5% DuraPeel or Placebo DuraPeel. The study duration will be approximately 4 weeks.
- Conditions
- Hand Dermatoses
- Being tested
- Triamcinolone Acetonide (TAC) DuraPeel, Placebo DuraPeel
- Keywords
- hand dermatitis, hand eczema, triamcinolone acetonide
- Medical subject headings
- Hand Dermatoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Acetonide (TAC) DuraPeelDrug
Also called TAC DuraPeel
topical gel; once daily (nightly); total duration: 4 weeks
Placebo DuraPeelDrug
topical gel; once daily (nightly); total duration: 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone Acetonide (TAC) DuraPeel | Experimental | Not described Receives: Drug: Triamcinolone Acetonide (TAC) DuraPeel |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo DuraPeel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response as assessed by Investigator Global Assessment (IGA)
Measured: Baseline, Week 1, Week 2, Week 4
Secondary outcomes (5)
Subject's Global Impression of Change (SGIC)
Measured: Week 4 (end-of-treatment)
Individual Primary Parameters of Hand Dermatitis
Measured: Baseline, Week 1, Week 2, Week 4
Signs or symptoms of hand dermatitis
Measured: Baseline, Week 1, Week 2, Week 4
Subject's self-assessment of overall hand disease
Measured: Baseline, Week 4
Study medication assessment
Measured: Week 1, Week 2, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand DermatosesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZARS Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Piacquadio, MD, Study director, Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890968
- Sponsor's protocol ID
- TAC-202
- Acronym
- TAC-202
- Status last verified
- Mar 2012
- First submitted
- 28 Apr 2009
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Randomized, Double-Blind, Placebo Controlled, Parallel Group Comparison Study of Once Daily Triamcinolone Acetonide 0.5% DuraPeel™ Versus Placebo DuraPeel in the Treatment of Hand Dermatitis
- ClinicalTrials.gov ID
- NCT00890968
- Acronym / sponsor ID
- TAC-202 / TAC-202
- Conditions
- Hand Dermatoses
- Keywords
- hand dermatitis, hand eczema, triamcinolone acetonide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- ZARS Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 30 Apr 2009 (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 Triamcinolone Acetonide (TAC) DuraPeel is safe and effective in the treatment of hand dermatitis.
Detailed description
Triamcinolone acetonide is a commonly used, safe, and effective topical corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. However, the effectiveness of topical agents such as creams or ointments is limited by patients' routine activities using bare hands that may remove the topical agent from the hands. The use of a topical corticosteroid in a vehicle that allows the product to remain in contact with the skin and is not susceptible to inadvertent removal would be beneficial.
The DuraPeel membrane is expected to optimize exposure to the steroid by remaining on the treatment area for a prolonged period of time.
This study is designed to evaluate the efficacy and safety of Triamcinolone Acetonide 0.5% DuraPeel. Eligible subjects will receive Triamcinolone Acetonide 0.5% DuraPeel or Placebo DuraPeel. The study duration will be approximately 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone Acetonide (TAC) DuraPeel | Experimental | Drug: Triamcinolone Acetonide (TAC) DuraPeel |
| Placebo | Placebo comparator | Drug: Placebo DuraPeel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of stable chronic hand dermatitis (greater than 6 weeks duration) that is KOH-negative
- Dermatitis of mild to moderate severity, as defined by an Investigator's Global Assessment (a score of 2 or 3 on the Target Hand)
- Individual signs of hand dermatitis disease of at least mild scaling and mild erythema (a score of 2 or more on the Target Hand)
- Written informed consent
Key exclusion criteria (14 listed)
- Subject is female and is pregnant, lactating, or is planning to become pregnant during the study
- Spontaneously improving or rapidly deteriorating hand dermatitis at the time of enrollment; subject may have history of waxing and waning disease in the past
- History of hand dermatitis that has been shown to be unresponsive to super potent (Group 1) topical steroids
- Concurrent flaring of inflammatory skin disease (e.g., atopic dermatitis or psoriasis) anywhere on the body outside the study areas
- Bullous disorders or hand, foot, and mouth disease (HFMD); however, subjects with dyshidrotic hand dermatitis or pompholyx are allowed to participate provided they meet all other Inclusion/Exclusion criteria
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 |
|---|---|---|
| Triamcinolone Acetonide (TAC) DuraPeelAlso: TAC DuraPeeltopical gel; once daily (nightly); total duration: 4 weeks | Drug | Triamcinolone Acetonide (TAC) DuraPeel |
| Placebo DuraPeeltopical gel; once daily (nightly); total duration: 4 weeks | Drug | Placebo |
Primary outcome
Response as assessed by Investigator Global Assessment (IGA)
Time frame: Baseline, Week 1, Week 2, Week 4
5 secondary outcomes
Subject's Global Impression of Change (SGIC)
Time frame: Week 4 (end-of-treatment)
Individual Primary Parameters of Hand Dermatitis
Time frame: Baseline, Week 1, Week 2, Week 4
Signs or symptoms of hand dermatitis
Time frame: Baseline, Week 1, Week 2, Week 4
Subject's self-assessment of overall hand disease
Time frame: Baseline, Week 4
Study medication assessment
Time frame: Week 1, Week 2, Week 4
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 16 Mar 2012.
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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.
Daniel Piacquadio, MD study director
Therapeutics, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Triamcinolone Acetonide (TAC) DuraPeel in people with Hand Dermatoses, run by ZARS Pharma Inc. at 3 sites 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 4 inclusion and 14 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 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Response as assessed by Investigator Global Assessment (IGA) (time frame: Baseline, Week 1, Week 2, Week 4). 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 16 Mar 2012.