Seborrheic KeratosisNCT01159860
Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?
A study testing cryosurgery and Curettage in people with Seborrheic Keratosis, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
Seborrheic keratoses (SK's) are very common, but harmless skin lesions that commonly appear during adult life. Patients with seborrheic keratoses frequently desire treatment due to symptoms of itching and irritation or for cosmetic purposes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Seborrheic Keratosis
- What is being tested?
- cryosurgery and Curettage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to 6 Jun 2013
- Phase
- Interventional
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- have at least 1 seborrheic keratosis on each side of his/her trunk or proximal extremities.
- be able to understand the consent form and evaluation of treatment questionnaire.
Who cannot join
- Children <18 are excluded from this study based on their inability to independently complete the informed consent and research associated questionnaire.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Seborrheic keratoses (SK's) are very common, but harmless skin lesions that commonly appear during adult life. Patients with seborrheic keratoses frequently desire treatment due to symptoms of itching and irritation or for cosmetic purposes. Seborrheic keratoses can be easily removed and have been treated in a number of different ways. Two of the simplest and most successful ways to remove seborrheic keratoses are cryosurgery and curettage.
The investigators are conducting this study to see which of these two treatments has the best result.
Approximately 24-30 people will take part in this research study at the Hershey Medical Center.
- Conditions
- Seborrheic Keratosis
- Being tested
- cryosurgery, Curettage
- Keywords
- seborrheic keratoses, cryosurgery, curettage
- Medical subject headings
- Keratosis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryosurgeryProcedure or surgery
freezing of lesion with liquid nitrogen
CurettageProcedure or surgery
the lesion will be anesthetized and destroyed with a curette.
| Study group | Role | What they receive |
|---|---|---|
| Cryosurgery | Active comparator | One lesion on the patients' trunk or proximal extremities will be treated with cryosurgery. Receives: Procedure: cryosurgery |
| Curettage | Active comparator | One lesion on one side of the patients' trunk or proximal extremities will be treated by curettage. Receives: Procedure: Curettage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial or complete resolution of treated lesion.
Follow up evaluation by a blinded physician along with the gathering of patient information via questionnaires will be obtained at the completion of the study.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startJul 2010
- Primary completion11 May 2012
- Study completion6 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Seborrheic KeratosisStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lance D. Wood, M.D., Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159860
- Sponsor's protocol ID
- IRB Protocol No. 33895
- Status last verified
- May 2018
- First submitted
- 9 Jul 2010
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Brodsky J. Management of benign skin lesions commonly affecting the face: actinic keratosis, seborrheic keratosis, and rosacea. Curr Opin Otolaryngol Head Neck Surg. 2009 Aug;17(4):315-20. doi: 10.1097/MOO.0b013e32832d75e3.
PubMed 19465852Herron MD, Bowen AR, Krueger GG. Seborrheic keratoses: a study comparing the standard cryosurgery with topical calcipotriene, topical tazarotene, and topical imiquimod. Int J Dermatol. 2004 Apr;43(4):300-2. doi: 10.1111/j.1365-4632.2004.02282.x.
PubMed 15090020
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Cryosurgery or Curettage More Effective at Treating Seborrheic Keratoses?
- ClinicalTrials.gov ID
- NCT01159860
- Acronym / sponsor ID
- IRB Protocol No. 33895
- Conditions
- Seborrheic Keratosis
- Keywords
- seborrheic keratoses, cryosurgery, curettage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- 11 May 2012 (actual)
- Study completion
- 6 Jun 2013 (actual)
- First posted
- 12 Jul 2010 (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.
Seborrheic keratoses (SK's) are very common, but harmless skin lesions that commonly appear during adult life. Patients with seborrheic keratoses frequently desire treatment due to symptoms of itching and irritation or for cosmetic purposes. Seborrheic keratoses can be easily removed and have been treated in a number of different ways. Two of the simplest and most successful ways to remove seborrheic keratoses are cryosurgery and curettage.
The investigators are conducting this study to see which of these two treatments has the best result.
Approximately 24-30 people will take part in this research study at the Hershey Medical Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryosurgery | Active comparator | Procedure: cryosurgeryOne lesion on the patients' trunk or proximal extremities will be treated with cryosurgery. |
| Curettage | Active comparator | Procedure: CurettageOne lesion on one side of the patients' trunk or proximal extremities will be treated by curettage. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- have at least 1 seborrheic keratosis on each side of his/her trunk or proximal extremities.
- be able to understand the consent form and evaluation of treatment questionnaire.
Key exclusion criteria (1 listed)
- Children <18 are excluded from this study based on their inability to independently complete the informed consent and research associated questionnaire.
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 |
|---|---|---|
| cryosurgeryfreezing of lesion with liquid nitrogen | Procedure or surgery | Cryosurgery |
| Curettagethe lesion will be anesthetized and destroyed with a curette. | Procedure or surgery | Curettage |
Primary outcome
Partial or complete resolution of treated lesion.
Time frame: 6 weeks
Follow up evaluation by a blinded physician along with the gathering of patient information via questionnaires will be obtained at the completion of the study.
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 25 May 2018.
- Background: PubMed 19465852Brodsky J. Management of benign skin lesions commonly affecting the face: actinic keratosis, seborrheic keratosis, and rosacea. Curr Opin Otolaryngol Head Neck Surg. 2009 Aug;17(4):315-20. doi: 10.1097/MOO.0b013e32832d75e3.
- Background: PubMed 15090020Herron MD, Bowen AR, Krueger GG. Seborrheic keratoses: a study comparing the standard cryosurgery with topical calcipotriene, topical tazarotene, and topical imiquimod. Int J Dermatol. 2004 Apr;43(4):300-2. doi: 10.1111/j.1365-4632.2004.02282.x.
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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.
Lance D. Wood, M.D. principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryosurgery and Curettage in people with Seborrheic Keratosis, run by Milton S. Hershey Medical Center 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 2 inclusion and 1 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 25 May 2018. 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.
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?
Partial or complete resolution of treated lesion. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01159860, which also lists 2 linked publications.
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 25 May 2018.