AlopeciaPhase 4NCT01111981
Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia
A Phase 4 study testing Clobetasol Propionate 0.05% Emollient Foam in people with Alopecia, run by Callender Center for Clinical Research at 1 site in United States.
Trial summary
The purpose of this study is to ascertain the safety and efficacy of Clobetasol Propionate 0.05% E Foam in the treatment of Central Centrifugal Cicatricial Alopecia. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Alopecia
- What is being tested?
- Clobetasol Propionate 0.05% Emollient Foam
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Oct 2010
- Phase
- Phase 4
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with CCCA, treated or untreated
- Score 0 - 1 on Scale/Questionnaire
- 18 years of age or older
- Women of African descent
Who cannot join
- Score > 1 on Scale/Questionnaire
- Alopecias other than CCCA, including alopecia arreata, lichen planopilaris, trichotillomania, and traction alopecia
- History of hair transplantation
- Children less than 18 years of age
- Males
- Women of non-African descent
Show all 9Show fewer
- Pregnancy or breastfeeding. Women of childbearing age must use reliable forms of contraception (e.g., abstinence, oral contraceptives, or spermicide and condoms)
- Anti-dandruff shampoo within 30 days
- Anti-inflammatory medications such as antibiotics (doxycycline, minocycline, rifampin, etc.), steroids (oral prednisone, topical corticosteroids,etc.), NSAIDs (ibuprofen, aspirin, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Callender Center for Clinical Research
Mitchellville, Maryland, 20721
Lynn Carter, BA, 301-249-0970, clinresearch@callenderskin.com
Niccole Mathews, 301-249-0970, clinresearch@callenderskin.com
About this study
Official title: Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in the Treatment of Central Centrifugal Cicatricial Alopecia
The purpose of this study is to ascertain the safety and efficacy of
Clobetasol Propionate 0.05% E Foam in the treatment of Central Centrifugal
Cicatricial Alopecia.
Read the detailed description
Central Centrifugal Cicatricial Alopecia (CCCA) is an inflammation-induced
hair loss starting in the central scalp and progressing centrifugally. The
cause of CCCA is unknown. Early diagnosis and treatment is essential to stop
or slow the progression of scarring and permanent hair loss. Once scarring
occurs, the hair follicles are obliterated and the hair cannot regrow. Thus,
anti-inflammatory medications are used to decrease inflammation. Current
treatment includes topical and intralesional corticosteroids, oral
antibiotics, and hair transplantation, all which may take months to years to
show improvement. There is no evidence-based medicine on how to treat
primary cicatricial alopecias. Clobestasol Propionate 0.05% Emollient Foam is
an FDA-approved and marketed topical corticosteroid for the treatment of the
inflammatory and pruritic manifestations of moderate to severe corticosteroid-
responsive dermatoses of the scalp. Many studies found the foam to be less
irritating than the original formulation.
- Conditions
- Alopecia
- Being tested
- Clobetasol Propionate 0.05% Emollient Foam
- Keywords
- alopecia, CCCA - Central Centrifugal Cicatricial Alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clobetasol Propionate 0.05% Emollient FoamDrug
Also called Olux-E
Clobetasol Propionate 0.05% E Foam to be applied to affected area once a day for 16 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of pruritis, tenderness, and pain
Measured: 4 months
Secondary outcomes (1)
Absence of inflammation on biopsy
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startOct 2009
- Primary completionFeb 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Callender Center for Clinical Research
- Sponsor type
- University, hospital or other
- Investigators
- Valerie Callender, M.D., Principal investigator, Callender Skin for Clinical ResearchCherie Young, M.D., Study director, Callender Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111981
- Sponsor's protocol ID
- VDC2009O
- Status last verified
- Apr 2010
- First submitted
- 26 Apr 2010
- Last updated
- 28 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Callender VD, Kazemi A, Young CM, Chappell JA, Sperling LC. Safety and Efficacy of Clobetasol Propionate 0.05% Emollient Foam for the Treatment of Central Centrifugal Cicatricial Alopecia. J Drugs Dermatol. 2020 Jul 1;19(7):719-724. doi: 10.36849/JDD.2020.5201.
PubMed 32726554
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in the Treatment of Central Centrifugal Cicatricial Alopecia
- ClinicalTrials.gov ID
- NCT01111981
- Acronym / sponsor ID
- VDC2009O
- Conditions
- Alopecia
- Keywords
- alopecia, CCCA - Central Centrifugal Cicatricial Alopecia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Callender Center for Clinical ResearchUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 28 Apr 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.
The purpose of this study is to ascertain the safety and efficacy of
Clobetasol Propionate 0.05% E Foam in the treatment of Central Centrifugal
Cicatricial Alopecia.
Detailed description
Central Centrifugal Cicatricial Alopecia (CCCA) is an inflammation-induced
hair loss starting in the central scalp and progressing centrifugally. The
cause of CCCA is unknown. Early diagnosis and treatment is essential to stop
or slow the progression of scarring and permanent hair loss. Once scarring
occurs, the hair follicles are obliterated and the hair cannot regrow. Thus,
anti-inflammatory medications are used to decrease inflammation. Current
treatment includes topical and intralesional corticosteroids, oral
antibiotics, and hair transplantation, all which may take months to years to
show improvement. There is no evidence-based medicine on how to treat
primary cicatricial alopecias. Clobestasol Propionate 0.05% Emollient Foam is
an FDA-approved and marketed topical corticosteroid for the treatment of the
inflammatory and pruritic manifestations of moderate to severe corticosteroid-
responsive dermatoses of the scalp. Many studies found the foam to be less
irritating than the original formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with CCCA, treated or untreated
- Score 0 - 1 on Scale/Questionnaire
- 18 years of age or older
- Women of African descent
Key exclusion criteria (9 listed)
- Score > 1 on Scale/Questionnaire
- Alopecias other than CCCA, including alopecia arreata, lichen planopilaris, trichotillomania, and traction alopecia
- History of hair transplantation
- Children less than 18 years of age
- Males
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 |
|---|---|---|
| Clobetasol Propionate 0.05% Emollient FoamAlso: Olux-EClobetasol Propionate 0.05% E Foam to be applied to affected area once a day for 16 weeks | Drug | – |
Primary outcome
Improvement of pruritis, tenderness, and pain
Time frame: 4 months
1 secondary outcome
Absence of inflammation on biopsy
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2010.
- Derived from this study: PubMed 32726554Callender VD, Kazemi A, Young CM, Chappell JA, Sperling LC. Safety and Efficacy of Clobetasol Propionate 0.05% Emollient Foam for the Treatment of Central Centrifugal Cicatricial Alopecia. J Drugs Dermatol. 2020 Jul 1;19(7):719-724. doi: 10.36849/JDD.2020.5201.
- Home Page to the Callender Skin \& Laser Center that includes "Research Studies" sectionLink provided by the sponsor.
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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.
Valerie Callender, M.D. principal investigator
Callender Skin for Clinical Research
Cherie Young, M.D. study director
Callender Center for Clinical Research
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 Clobetasol Propionate 0.05% Emollient Foam in people with Alopecia, run by Callender Center for Clinical Research 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Apr 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lynn Carter, BA (301-249-0970, clinresearch@callenderskin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of pruritis, tenderness, and pain (time frame: 4 months). 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 NCT01111981, which also lists 1 linked publication.
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 28 Apr 2010.