Central Centrifugal Scarring AlopeciaNCT00691769
Expression of Fas Protein in Skin Biopsies of Participants With Scarring Alopecia
An observational study of Central Centrifugal Scarring Alopecia and Lichen Planopilaris, run by Wake Forest University at 1 site in United States.
Trial summary
The purpose of this research study is to see if a specific protein that we are interested in is involved in scarring hair loss. If these proteins are involved, further genetic work may also better define the disease as well as future treatment options. Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Central Centrifugal Scarring Alopecia, Lichen Planopilaris, Discoid Lupus Erythematosus
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2006to 26 Nov 2012
- Phase
- Observational
- 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 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Wake Forest University Health Sciences Dermatology Clinic.
Who may be able to join
- Participants ages 30 years or older with a biopsy- proven diagnosis of CCSA.
- Undergone standard of care treatment for CCSA by a WFUSM Dermatologist
- Women of child bearing age will be required to have a negative pregnancy test in order to participate in the study
- Participants ages 30 years or older with a biopsy- proven diagnosis of LP.
- Participants ages 30 years or older with a biopsy- proven diagnosis of DLE.
- Healthy participants must be ages 30 years or older.
Who cannot join
- Age less than 30 years of age.
- Clinically evident bacterial or viral infection of the scalp.
- Pregnant or nursing woman of child-bearing potential.
- Participation in any other investigative research study involving study medication.
- Inability to return for the biopsy visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences Dermatology
Winston-Salem, North Carolina, 27157
About this study
The purpose of this research study is to see if a specific protein that we are interested in is involved in scarring hair loss. If these proteins are involved, further genetic work may also better define the disease as well as future treatment options.
Read the detailed description
This is a single-center study, designed to evaluate the expression of Fas protein in skin biopsies of patients with scarring alopecia including fourteen patients with central centrifugal scarring alopecia (CCSA), three patients with lichen planopilaris (LP) and three patients with discoid lupus erythematosus (DLE). Skin biopsies of five healthy participants will be used as controls.
- Keywords
- alopecia, lupus
- Medical subject headings
- Lichen Planus, Lupus Erythematosus, Discoid, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| I | CCSA subjects will be recruited from patients who have been diagnosed through biopsy with CCSA and treated with standard of care for up to eight months in the Department of Dermatology clinic of Wake Forest University School of Medicine. | |
| II | patients with lichen planopilaris (LP) and patients with discoid lupus erythematosus (DLE) will be collected from patients who have been diagnosed through biopsy in the clinic. | |
| III | Healthy study subjects will be patients from the Wake Forest University School of Medicine Department of Dermatology population undergoing excisions for cosmetic purposes or excision of free margins around tumors that would have otherwise been discarded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the expression of Fas protein in skin biopsies of participants with central centrifugal scarring alopecia (CCSA), lichen planopilaris (LP) and discoid lupus erythematosus (DLE) and in healthy controls.
Measured: 8 weeks
Secondary outcomes (1)
To evaluate the expression of Fas protein in skin biopsies of participants with central centrifugal scarring alopecia before and after treatment with intralesional and topical steroids.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study start26 Apr 2006
- Primary completion26 Nov 2012
- Study completion26 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Centrifugal Scarring AlopeciaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy McMichael, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691769
- Sponsor's protocol ID
- IRB00000301
- Other IDs
- 31050
- Status last verified
- Jul 2018
- First submitted
- 2 Jun 2008
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Fas Protein in Skin Biopsies of Participants With Scarring Alopecia
- ClinicalTrials.gov ID
- NCT00691769
- Acronym / sponsor ID
- IRB00000301
- Keywords
- alopecia, lupus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- 26 Apr 2006 (actual)
- Primary completion
- 26 Nov 2012 (actual)
- Study completion
- 26 Nov 2012 (actual)
- First posted
- 5 Jun 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 research study is to see if a specific protein that we are interested in is involved in scarring hair loss. If these proteins are involved, further genetic work may also better define the disease as well as future treatment options.
Detailed description
This is a single-center study, designed to evaluate the expression of Fas protein in skin biopsies of patients with scarring alopecia including fourteen patients with central centrifugal scarring alopecia (CCSA), three patients with lichen planopilaris (LP) and three patients with discoid lupus erythematosus (DLE). Skin biopsies of five healthy participants will be used as controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I | – | –CCSA subjects will be recruited from patients who have been diagnosed through biopsy with CCSA and treated with standard of care for up to eight months in the Department of Dermatology clinic of Wake Forest University School of Medicine. |
| II | – | –patients with lichen planopilaris (LP) and patients with discoid lupus erythematosus (DLE) will be collected from patients who have been diagnosed through biopsy in the clinic. |
| III | – | –Healthy study subjects will be patients from the Wake Forest University School of Medicine Department of Dermatology population undergoing excisions for cosmetic purposes or excision of free margins around tumors that would have otherwise been discarded. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Wake Forest University Health Sciences Dermatology Clinic.
Key inclusion criteria (6 listed)
- Participants ages 30 years or older with a biopsy- proven diagnosis of CCSA.
- Undergone standard of care treatment for CCSA by a WFUSM Dermatologist
- Women of child bearing age will be required to have a negative pregnancy test in order to participate in the study
- Participants ages 30 years or older with a biopsy- proven diagnosis of LP.
- Participants ages 30 years or older with a biopsy- proven diagnosis of DLE.
Key exclusion criteria (5 listed)
- Age less than 30 years of age.
- Clinically evident bacterial or viral infection of the scalp.
- Pregnant or nursing woman of child-bearing potential.
- Participation in any other investigative research study involving study medication.
- Inability to return for the biopsy visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the expression of Fas protein in skin biopsies of participants with central centrifugal scarring alopecia (CCSA), lichen planopilaris (LP) and discoid lupus erythematosus (DLE) and in healthy controls.
Time frame: 8 weeks
1 secondary outcome
To evaluate the expression of Fas protein in skin biopsies of participants with central centrifugal scarring alopecia before and after treatment with intralesional and topical steroids.
Time frame: 8 weeks
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 6 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Amy McMichael, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Centrifugal Scarring Alopecia and Lichen Planopilaris, run by Wake Forest 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 6 inclusion and 5 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 6 Jul 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?
To evaluate the expression of Fas protein in skin biopsies of participants with central centrifugal scarring alopecia (CCSA), lichen planopilaris (LP) and discoid lupus erythematosus (DLE) and in healthy controls. (time frame: 8 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 6 Jul 2018.