Scarring AlopeciaNCT03044782
Barriers to Care and QOL for CCCA Patients
An observational study of Scarring Alopecia and Central Centrifugal Cicatricial Alopecia, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of the current project is twofold; first to determine what personal, historical, logistical, and environmental factors preclude women from obtaining medical care for CCCA hair loss. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scarring Alopecia, Central Centrifugal Cicatricial Alopecia, Central Centrifugal Scarring Alopecia
- What is being tested?
- 53-Item Survey
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Sep 2017
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women diagnosed with CCCA who have been seen at Northwestern Dermatology between 10/1/15 and 9/30/17.
Who may be able to join
- Evaluated in the Northwestern Dermatology Department between October 1, 2015 and September 30, 2017.
- Evaluated by any faculty physician.
- Diagnosed with CCCA.
- Age 18 or older.
- All subjects must have given signed informed consent prior to participation in study.
Who cannot join
- Non-English speakers (interpreters not available)
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: Barriers to Healthcare and Quality of Life for Central Centrifugal Cicatricial Alopecia Patients
The purpose of the current project is twofold; first to determine what personal, historical, logistical, and environmental factors preclude women from obtaining medical care for CCCA hair loss. Because damage from CCCA is irreversible, early identification and treatment is paramount to limiting the negative ramifications of the disease. Second, to investigate how CCCA hair loss, a common occurrence in the Black population, can be a significant psychological impediment to lives of affected Black women. Based on previous research on the psychosocial impact of generalized hair loss in Black women, it is fair to consider that CCCA hair loss also leads to problems with self-esteem and participation in daily life activities. This research, the first of its kind, will add to existing knowledge of CCCA by investigating the quality of life and barriers to care of patients with this condition. The goal of this study is to illuminate what stands in the way of secondary and tertiary prevention of CCCA patients and tailor treatment strategies to address their needs. The results of this study will be instrumental in modifying dermatology resident training, adding to existing dermatology management guidelines, and even developing public health advocacy programming.
- Conditions
- Scarring Alopecia, Central Centrifugal Cicatricial Alopecia, Central Centrifugal Scarring Alopecia
- Being tested
- 53-Item Survey
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
53-Item SurveyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantified Barriers to Care Survey Responses
Measured: Duration of study-approximately 2 years
Quantified Quality of Life Survey Responses
Measured: Duration of study-approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study startAug 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Scarring AlopeciaStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roopal Kundu, Northwestern University
- Investigators
- Roopal Kundu, MD, Principal investigator, Northwestern Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044782
- Sponsor's protocol ID
- SP070316
- Status last verified
- Dec 2017
- First submitted
- 16 Dec 2016
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Dlova NC, Forder M. Central centrifugal cicatricial alopecia: possible familial aetiology in two African families from South Africa. Int J Dermatol. 2012 Nov;51 Suppl 1:17-20, 20-3. doi: 10.1111/j.1365-4632.2012.05557.x. No abstract available. English, French.
PubMed 23210944Gathers RC, Jankowski M, Eide M, Lim HW. Hair grooming practices and central centrifugal cicatricial alopecia. J Am Acad Dermatol. 2009 Apr;60(4):574-8. doi: 10.1016/j.jaad.2008.10.064.
PubMed 19293007Gathers RC, Mahan MG. African american women, hair care, and health barriers. J Clin Aesthet Dermatol. 2014 Sep;7(9):26-9.
PubMed 25276273Halder RM, Grimes PE, McLaurin CI, Kress MA, Kenney JA Jr. Incidence of common dermatoses in a predominantly black dermatologic practice. Cutis. 1983 Oct;32(4):388, 390.
PubMed 6226496Mkentane K, Maneli M, Khumalo NP, Davids LM, Freedom G. Relaxers damage hair and increase fragility. Int J Dermatol. 2014 Mar;53(3):e200-2. doi: 10.1111/ijd.12283. No abstract available.
PubMed 24571594Summers P, Kyei A, Bergfeld W. Central centrifugal cicatricial alopecia - an approach to diagnosis and management. Int J Dermatol. 2011 Dec;50(12):1457-64. doi: 10.1111/j.1365-4632.2011.05098.x.
PubMed 22097988Kyei A, Bergfeld WF, Piliang M, Summers P. Medical and environmental risk factors for the development of central centrifugal cicatricial alopecia: a population study. Arch Dermatol. 2011 Aug;147(8):909-14. doi: 10.1001/archdermatol.2011.66. Epub 2011 Apr 11.
PubMed 21482861LoPresti P, Papa CM, Kligman AM. Hot comb alopecia. Arch Dermatol. 1968 Sep;98(3):234-8. No abstract available.
PubMed 5673883Ogunleye TA, McMichael A, Olsen EA. Central centrifugal cicatricial alopecia: what has been achieved, current clues for future research. Dermatol Clin. 2014 Apr;32(2):173-81. doi: 10.1016/j.det.2013.12.005. Epub 2014 Jan 22.
PubMed 24680004McMichael AJ. Ethnic hair update: past and present. J Am Acad Dermatol. 2003 Jun;48(6 Suppl):S127-33. doi: 10.1067/mjd.2003.278.
PubMed 12789165Sperling LC, Cowper SE. The histopathology of primary cicatricial alopecia. Semin Cutan Med Surg. 2006 Mar;25(1):41-50. doi: 10.1016/j.sder.2006.01.006.
PubMed 16616302Sperling LC, Sau P. The follicular degeneration syndrome in black patients. 'Hot comb alopecia' revisited and revised. Arch Dermatol. 1992 Jan;128(1):68-74.
PubMed 1739290Sperling LC, Solomon AR, Whiting DA. A new look at scarring alopecia. Arch Dermatol. 2000 Feb;136(2):235-42. doi: 10.1001/archderm.136.2.235. No abstract available.
PubMed 10677100Mukherjee N, Morrell DS, Duvic M, Stewart PW, Goldsmith LA. Attitudes of dermatologists in the southeastern United States regarding treatment of alopecia areata: a cross-sectional survey study. BMC Dermatol. 2009 Nov 12;9:11. doi: 10.1186/1471-5945-9-11.
PubMed 19909522
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers to Healthcare and Quality of Life for Central Centrifugal Cicatricial Alopecia Patients
- ClinicalTrials.gov ID
- NCT03044782
- Acronym / sponsor ID
- SP070316
- Conditions
- Scarring Alopecia, Central Centrifugal Cicatricial Alopecia, Central Centrifugal Scarring Alopecia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 7 Feb 2017 (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 the current project is twofold; first to determine what personal, historical, logistical, and environmental factors preclude women from obtaining medical care for CCCA hair loss. Because damage from CCCA is irreversible, early identification and treatment is paramount to limiting the negative ramifications of the disease. Second, to investigate how CCCA hair loss, a common occurrence in the Black population, can be a significant psychological impediment to lives of affected Black women. Based on previous research on the psychosocial impact of generalized hair loss in Black women, it is fair to consider that CCCA hair loss also leads to problems with self-esteem and participation in daily life activities. This research, the first of its kind, will add to existing knowledge of CCCA by investigating the quality of life and barriers to care of patients with this condition. The goal of this study is to illuminate what stands in the way of secondary and tertiary prevention of CCCA patients and tailor treatment strategies to address their needs. The results of this study will be instrumental in modifying dermatology resident training, adding to existing dermatology management guidelines, and even developing public health advocacy programming.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women diagnosed with CCCA who have been seen at Northwestern Dermatology between 10/1/15 and 9/30/17.
Key inclusion criteria (5 listed)
- Evaluated in the Northwestern Dermatology Department between October 1, 2015 and September 30, 2017.
- Evaluated by any faculty physician.
- Diagnosed with CCCA.
- Age 18 or older.
- All subjects must have given signed informed consent prior to participation in study.
Key exclusion criteria (1 listed)
- Non-English speakers (interpreters not available)
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 |
|---|---|---|
| 53-Item Survey | Other | – |
Primary outcome
Quantified Barriers to Care Survey Responses
Time frame: Duration of study-approximately 2 years
Quantified Quality of Life Survey Responses
Time frame: Duration of study-approximately 2 years
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 13 Dec 2017.
- Results publication: PubMed 23210944Dlova NC, Forder M. Central centrifugal cicatricial alopecia: possible familial aetiology in two African families from South Africa. Int J Dermatol. 2012 Nov;51 Suppl 1:17-20, 20-3. doi: 10.1111/j.1365-4632.2012.05557.x. No abstract available. English, French.
- Results publication: PubMed 19293007Gathers RC, Jankowski M, Eide M, Lim HW. Hair grooming practices and central centrifugal cicatricial alopecia. J Am Acad Dermatol. 2009 Apr;60(4):574-8. doi: 10.1016/j.jaad.2008.10.064.
- Results publication: PubMed 25276273Gathers RC, Mahan MG. African american women, hair care, and health barriers. J Clin Aesthet Dermatol. 2014 Sep;7(9):26-9.
- Results publication: PubMed 6226496Halder RM, Grimes PE, McLaurin CI, Kress MA, Kenney JA Jr. Incidence of common dermatoses in a predominantly black dermatologic practice. Cutis. 1983 Oct;32(4):388, 390.
- Results publication: PubMed 24571594Mkentane K, Maneli M, Khumalo NP, Davids LM, Freedom G. Relaxers damage hair and increase fragility. Int J Dermatol. 2014 Mar;53(3):e200-2. doi: 10.1111/ijd.12283. No abstract available.
- Results publication: PubMed 22097988Summers P, Kyei A, Bergfeld W. Central centrifugal cicatricial alopecia - an approach to diagnosis and management. Int J Dermatol. 2011 Dec;50(12):1457-64. doi: 10.1111/j.1365-4632.2011.05098.x.
- Results publication: PubMed 21482861Kyei A, Bergfeld WF, Piliang M, Summers P. Medical and environmental risk factors for the development of central centrifugal cicatricial alopecia: a population study. Arch Dermatol. 2011 Aug;147(8):909-14. doi: 10.1001/archdermatol.2011.66. Epub 2011 Apr 11.
- Results publication: PubMed 5673883LoPresti P, Papa CM, Kligman AM. Hot comb alopecia. Arch Dermatol. 1968 Sep;98(3):234-8. No abstract available.
- Results publication: PubMed 24680004Ogunleye TA, McMichael A, Olsen EA. Central centrifugal cicatricial alopecia: what has been achieved, current clues for future research. Dermatol Clin. 2014 Apr;32(2):173-81. doi: 10.1016/j.det.2013.12.005. Epub 2014 Jan 22.
- Results publication: PubMed 12789165McMichael AJ. Ethnic hair update: past and present. J Am Acad Dermatol. 2003 Jun;48(6 Suppl):S127-33. doi: 10.1067/mjd.2003.278.
- Results publication: PubMed 16616302Sperling LC, Cowper SE. The histopathology of primary cicatricial alopecia. Semin Cutan Med Surg. 2006 Mar;25(1):41-50. doi: 10.1016/j.sder.2006.01.006.
- Results publication: PubMed 1739290Sperling LC, Sau P. The follicular degeneration syndrome in black patients. 'Hot comb alopecia' revisited and revised. Arch Dermatol. 1992 Jan;128(1):68-74.
- Individual participant dataSharing planned: Undecided
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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.
Roopal Kundu, MD principal investigator
Northwestern Department of Dermatology
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 Scarring Alopecia and Central Centrifugal Cicatricial Alopecia, run by Northwestern 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 5 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 13 Dec 2017. 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?
Quantified Barriers to Care Survey Responses (time frame: Duration of study-approximately 2 years). The study lists 2 primary outcomes in all. 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 NCT03044782, which also lists 14 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 13 Dec 2017.