Keratosis PilarisPhase 4NCT00944216
Efficacy and Safety of Salkera Emollient Foam in the Treatment of Moderate to Severe Keratosis Pilaris, a Prospective Study
A Phase 4 study testing Salkera Emollient Foam in people with Keratosis Pilaris, run by Wright State University at 1 site in United States.
Trial summary
Keratosis pilaris (KP) is a benign skin condition that often is very frustrating for the patients and treating physicians. The investigators are interested to see if the study product is effective in treating moderate to severe KP. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratosis Pilaris
- What is being tested?
- Salkera Emollient Foam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jan 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is willing and able to give informed consent.
- Subject is willing and able to participate in the study as an outpatient and is willing to comply with the study requirements.
- Subject is 18 years of age or older.
- Subject has KP on 2 out of the 4 extremities.
- For each assessed extremity, subject has at least a moderate severity (≥ 3) on the Investigator Site Assessment of KP Severity.
- For each assessed extremity, subject has an aggregate score of at least 6 on the Investigator Assessment of Erythema, Roughness and Scaling.
- If subject is a female of childbearing potential, subject will have a negative urine pregnancy test at screening (week 0).
- If female, subject will be either post-menopausal for > 2 year, surgically sterile (hysterectomy or bilateral tubal ligation), or practicing one form of birth control (abstinence, oral contraceptive, estrogen patch, implant contraception, injectable contraception, IUD, diaphragm, condom, sponge, spermicides, or vasectomy of partner). Female subjects should continue to practice birth control for 1 month after the completion of study.
Who cannot join
- Subject has evidence of a clinically significant, unstable or poorly controlled medical condition as determined by the investigators/sub-investigators.
- Subject has active skin infection, atopic dermatitis or any other skin disease that will interfere with the clinical assessment of KP.
- Subject has known allergies to any ingredient of study medication.
- Subject who has used any of the following topical therapies for KP lesions within the last two weeks: topical corticosteroid, tretinoin, tazarotene, adapalene, salicylic acid, alpha-hydroxy acid, urea and/or ammonium lactate lotion.
- Subject who has been treated with UVB therapy in the last two weeks.
- Subject who has received systemic antibiotics, steroid, tacrolimus, tretinoin, isotretinoin and/or PUVA within the last 4 weeks.
- Female subjects who are pregnant (positive urine pregnancy test), breast-feeding or are considering become pregnant during the study period.
- Subject who is currently participating in another clinical trial or has completed a clinical trial within the last 4 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wright State University School of Medicine, Department of Dermatology
Dayton, Ohio, 45408
About this study
Keratosis pilaris (KP) is a benign skin condition that often is very frustrating for the patients and treating physicians. The investigators are interested to see if the study product is effective in treating moderate to severe KP.
Read the detailed description
Keratosis pilaris (KP) is a benign, inherited skin disorder that presents as grouped, rough, horny follicular papules. It is estimated that 40-50% of the adult population and 50-80% of adolescents suffer from KP. Both men and women are affected, with a possible female predominance. It is noted worldwide and shows no racial predilection. Most patients with KP are actually unaware that the condition has a designed medical term. Although no clear etiology had been identified, KP is sometimes associated with other skin conditions such as icththyosis vulgaris, xerosis or atopic dermatitis.
Many patients with KP never seek medical attention since they are asymptomatic. However, KP can create significant cosmetic concerns in some cases. It can also become symptomatic especially when inflammatory lesions are present. There is no gold standard treatment for KP. Prevention of excessive dryness of the skin and continued moisturization are used currently as standard of care. Many topical agents such as tretinoin, ammonium lactate lotion, urea creams, tazarotene, adapalene, tacrolimus, alpha hydroxy acids and salicylic acids have been used with variable results. Sometimes topical corticosteroids are used, especially when inflammation is present. In general, KP treatments need to be continuous and complete clearance may not be possible.
Salkera emollient foam is a keratolytic foam containing 6% salicylic acid in an aqueous based emollient foam vehicle. It is different from other salicylic containing topical product in that it has been shown to produce desquamation of the stratum corneum while not effecting qualitative or quantitative changes in the structure of the viable dermis. In addition, it also contains aloe vera and anti-oxidants which help to sooth the skin. Salkera emollient foam has been used to treat several hyperkeratotic skin disorders such as KP, psoriasis, keratosis palmaris/plantaris, verrucae, icthyoses and pityriasis rubra pilaris. However, there has been no published study assessing the efficacy and safety of Salkera emollient foam in treating moderate to severe KP.
This prospective single center pilot study is designed to assess the efficacy and safety of Salkera emollient foam in treating moderate to severe KP. Patients' cosmetic acceptance of the product will also be assessed. In addition, this study is also designed to develop a validated outcome measure for assessing KP severity that can be used in future KP clinical trials.
- Conditions
- Keratosis Pilaris
- Being tested
- Salkera Emollient Foam
- Keywords
- keratosis pilaris
- Medical subject headings
- Burnett Schwartz Berberian syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salkera Emollient FoamDrug
application of the Salkera emollient foam twice a day during the 12 week study period.
| Study group | Role | What they receive |
|---|---|---|
| Salkera Emollient Foam Treatment | Experimental | All participants will receive this intervention. Receives: Drug: Salkera Emollient Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences Between Week 0 and Week 12 Aggregate Site Severity Score and Investigator Assessment for Site Disease Severity for All Studied Patients.
Measured: 12 weeks
Secondary outcomes (1)
Change of Subject Assessment of Overall Disease Severity Between Week 0 and Week 12.
Subject disease severity score: None (0), mild (1), mild/moderate (2), moderate (3), moderate/severe (4), severe (5).
Measured: 12 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: terminated due to administrative reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Keratosis PilarisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wright State University
- Sponsor type
- University, hospital or other
- Collaborators
- PreCision Dermatology, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944216
- Sponsor's protocol ID
- KP
- Status last verified
- Feb 2022
- First submitted
- 21 Jul 2009
- Last updated
- 4 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Salkera Emollient Foam in the Treatment of Moderate to Severe Keratosis Pilaris, a Prospective Study
- ClinicalTrials.gov ID
- NCT00944216
- Acronym / sponsor ID
- KP
- Conditions
- Keratosis Pilaris
- Keywords
- keratosis pilaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated due to administrative reasons.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Collaborators
- PreCision Dermatology, Inc.
- Study start
- Jun 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 23 Jul 2009 (estimated)
- Results
- Posted 4 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Keratosis pilaris (KP) is a benign skin condition that often is very frustrating for the patients and treating physicians. The investigators are interested to see if the study product is effective in treating moderate to severe KP.
Detailed description
Keratosis pilaris (KP) is a benign, inherited skin disorder that presents as grouped, rough, horny follicular papules. It is estimated that 40-50% of the adult population and 50-80% of adolescents suffer from KP. Both men and women are affected, with a possible female predominance. It is noted worldwide and shows no racial predilection. Most patients with KP are actually unaware that the condition has a designed medical term. Although no clear etiology had been identified, KP is sometimes associated with other skin conditions such as icththyosis vulgaris, xerosis or atopic dermatitis.
Many patients with KP never seek medical attention since they are asymptomatic. However, KP can create significant cosmetic concerns in some cases. It can also become symptomatic especially when inflammatory lesions are present. There is no gold standard treatment for KP. Prevention of excessive dryness of the skin and continued moisturization are used currently as standard of care. Many topical agents such as tretinoin, ammonium lactate lotion, urea creams, tazarotene, adapalene, tacrolimus, alpha hydroxy acids and salicylic acids have been used with variable results. Sometimes topical corticosteroids are used, especially when inflammation is present. In general, KP treatments need to be continuous and complete clearance may not be possible.
Salkera emollient foam is a keratolytic foam containing 6% salicylic acid in an aqueous based emollient foam vehicle. It is different from other salicylic containing topical product in that it has been shown to produce desquamation of the stratum corneum while not effecting qualitative or quantitative changes in the structure of the viable dermis. In addition, it also contains aloe vera and anti-oxidants which help to sooth the skin. Salkera emollient foam has been used to treat several hyperkeratotic skin disorders such as KP, psoriasis, keratosis palmaris/plantaris, verrucae, icthyoses and pityriasis rubra pilaris. However, there has been no published study assessing the efficacy and safety of Salkera emollient foam in treating moderate to severe KP.
This prospective single center pilot study is designed to assess the efficacy and safety of Salkera emollient foam in treating moderate to severe KP. Patients' cosmetic acceptance of the product will also be assessed. In addition, this study is also designed to develop a validated outcome measure for assessing KP severity that can be used in future KP clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salkera Emollient Foam Treatment | Experimental | Drug: Salkera Emollient FoamAll participants will receive this intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is willing and able to give informed consent.
- Subject is willing and able to participate in the study as an outpatient and is willing to comply with the study requirements.
- Subject is 18 years of age or older.
- Subject has KP on 2 out of the 4 extremities.
- For each assessed extremity, subject has at least a moderate severity (≥ 3) on the Investigator Site Assessment of KP Severity.
Key exclusion criteria (8 listed)
- Subject has evidence of a clinically significant, unstable or poorly controlled medical condition as determined by the investigators/sub-investigators.
- Subject has active skin infection, atopic dermatitis or any other skin disease that will interfere with the clinical assessment of KP.
- Subject has known allergies to any ingredient of study medication.
- Subject who has used any of the following topical therapies for KP lesions within the last two weeks: topical corticosteroid, tretinoin, tazarotene, adapalene, salicylic acid, alpha-hydroxy acid, urea and/or ammonium lactate lotion.
- Subject who has been treated with UVB therapy in the last two weeks.
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 |
|---|---|---|
| Salkera Emollient Foamapplication of the Salkera emollient foam twice a day during the 12 week study period. | Drug | Salkera Emollient Foam Treatment |
Primary outcome
Differences Between Week 0 and Week 12 Aggregate Site Severity Score and Investigator Assessment for Site Disease Severity for All Studied Patients.
Time frame: 12 weeks
1 secondary outcome
Change of Subject Assessment of Overall Disease Severity Between Week 0 and Week 12.
Time frame: 12 wks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Recruiting
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Salkera Emollient Foam in people with Keratosis Pilaris, run by Wright State 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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 4 Feb 2022. 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?
Yes. Results are posted in the registry (first posted 4 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Differences Between Week 0 and Week 12 Aggregate Site Severity Score and Investigator Assessment for Site Disease Severity for All Studied Patients. (time frame: 12 weeks). 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 4 Feb 2022.