Frontal Fibrosing AlopeciaPhase 4NCT03422640
Trial Evaluating the Efficacy of Apremilast for the Treatment of Frontal Fibrosing Alopecia
A Phase 4 study testing Apremilast in people with Frontal Fibrosing Alopecia, run by Bellevue Dermatology at 1 site in United States.
Trial summary
This is open label single side study involvement 20 patient treated with Apremilast. Each enrolled patient may be evaluated at by a dermatologist using the Lichen Planopilaris Activity Index and Frontal Fibrosing Alopecia Index. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frontal Fibrosing Alopecia
- What is being tested?
- Apremilast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2018to Jan 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
- Male or Female and is at least 18 years of age, at the time of enrollment.
- Females of childbearing potential (FCBP)† must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive§ options described below: Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; 3. OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product.
- † A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) consecutive months (that is, has had menses at any time during the preceding 24 consecutive months).
- § The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).
- Patients with an established diagnosis of FFA based on the enrolling investigator's clinical judgment
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- Patients who have been treated and failed one standard therapy including
- Topical steroids
- Short course systemic steroids
- Systemic antibiotics
- Patients who are on stable dose of topical steroids or systemic antibiotics
- Patient and/or legal guardian has voluntarily signed and dated an informed consent/patient authorization form approved by an Institutional Review Board (IRB)/Ethics Committee (EC) if applicable according to local law, after the nature of the study has been explained and the patient has had the opportunity to ask questions.
Who cannot join
- Other than disease under study, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
- Prior history of suicide attempt at any time in the subject's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
- Pregnant or breast feeding.
- Active substance abuse or a history of substance abuse within 6 months prior to Screening.
- Malignancy or history of malignancy, except for: a. treated [ie, cured] basal cell or squamous cell in situ skin carcinomas; b. treated [ie, cured] cervical intraepithelial neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years.
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- Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
- Prior treatment with apremilast.
- Patient who have underlying chronic infections including HIV, Hep B and C.
- History of uncontrolled depression.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Bellevue Dermatology
Bellevue, Washington, 98004
Clive M Liu, MD, 425-455-2275, Cliveliumd@gmail.com
About this study
Official title: Open Label Trial Evaluating the Efficacy of Apremilast for the Treatment of Frontal Fibrosing Alopecia
This is open label single side study involvement 20 patient treated with Apremilast. Each enrolled patient may be evaluated at by a dermatologist using the Lichen Planopilaris Activity Index and Frontal Fibrosing Alopecia Index. Other measures include physician global assessment, dermatology quality of life and patients analogue score for pruritus. Pt will have visits at Week 0,2,4,8,12,16,20,24
Read the detailed description
Frontal fibrosing alopecia (FFA) is a chronic immune mediated inflammatory disease characterized by inflammation of the hair follicle and scaring hair loss. Clinically, FFA presents as a progressive recession of the hairline in a frontal temporal distribution. Evidence suggests that timely and effective management can prevent the permanent loss of hair. Unfortunately, most current treatment have been disappointing with poor efficacy or high risk profile. The available of a safe effective treatment for this disease remains an unmet need Apremilast is a novel phosphodiesterase 4 inhibitor currently FDA approved to treat psoriasis and is under investigation for other auto immune conditions. The medication has a good safety profile with no required laboratory monitoring. This study primarily aimsto determine whether Apremilast offers any benefit for this difficult to treatment population
- Conditions
- Frontal Fibrosing Alopecia
- Being tested
- Apremilast
- Keywords
- Frontal Fibrosing Alopecia, Apremilast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Also called Otezla
Open label treatment with apremilast
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm with apremilast | Experimental | Open label arm treating frontal fibrosing alopecia with apremilast Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lichen Planopilaris index
The weights given to the symptoms (30%), signs (30%), anagen pull test (25%), and presence of spreading (15%) led to the equation: LPPAI (0-10) = (pruritus + pain + burning)/3 + (scalp erythema + perifollicular erythema + perifollicular scale)/3 + 2.5 (pull test) + 1.5 (spreading/2).
Symptoms and signs are recorded on a 4-point scale. The anagen pull test involves grasping a small group of 10 to 20 hairs between the thumb, second finger, and third finger at the scalp end of the hair shafts, and pulling away from the scalp with a slow, firm perpendicular force to slide the fingers to the ends of the hair. The result is recorded both as a binary value (0 for no anagen hairs and 1 for the presence of anagen hairs) and as anagen hairs/total hairs pulled. Last is the assessment of spreading, recorded as 0 (no spreading) versus 1 (indeterminate) versus 2 (spreading).
Our primary endpoint is percentage change from baseline
Measured: Week 0 to 24, patient visit week0,2,4,8,12,16,20,24
Secondary outcomes (4)
Physicians global assessment
Physicians global assessment This is a a five point scale used to measure the severity of the disease at the time of the physicians evaluation. 0-Clear, 1-Almost Clear, 2-Mild, 3-Moderate, 4-Severe The lower the score the better the score
Measured: Weeks 0 to 24, patient visit week 0,2,4,8,12,16,20,24
Visual Analogue Scale Pruritus
Patient draws a line that best represent the severity of itch: this is continuous scale from 0-10, 0 being no itching and 10 being worst possible itching. Patient is to draw a line along the scale that represent the itch.
Measured: Weeks 0 to 24, patient visit week 0,2,4,8,12,16,20,24
Frontal Fibrosing Alopecia Index
This is a scoring system recently proposed by Holmes et al from the British Nail and Hair society. FFASI was compiled in two forms: FFASI and FFASI B. FFASI utilizes clinical images of the entire hairline, divided into four sections. Alopecia severity is graded 1-5 based on hairline recession. In order that hairline recession comprises the greatest proportion of the assessment, each grade is weighted. Nonscalp hair loss (eyebrow, eyelash, limb and flexural) are scored, as are associated features (facial papules; cutaneous, nail and mucosal lichen planus;and generalized scalp lichen planopilaris). Scores for hairline recession, inflammatory band, nonscalp loss and associated features may be combined to give a maximum score of 100. FFASI B uses the same format, but rather than grading alopecia it permits user-defined measurement of each hairline section. We will look at mean change in FFASI compared to baseline
Measured: Weeks 0 to 24, patient visit weeks 0,2,4,8,12,16,20,24
Dermatology Quality of Life (DLQI) (Appendix E) Dermatology Quality of Life (DLQI) (Appendix E) Dermatology Quality of Life (DLQI)
This is a questionnaire which measures how much a subjects skin problems affect his life over the last week. It is a series of 10 questions regarding various daily activities and each question consist of 4 responses from Very much, A lot, A little to Not at all. 0-being not at all or not relevant , 1-a little, 2-a lot, 3-very much in addition question 7, 3-prevent work or studying, the scores are added together for total score. Interpretation of score: 0-1 No affect on patient's life, 2-4 small affect on patient's life, 6-10 moderate affect on patient's life, 11-20 large on affect on patien's life, 21-30 extreme affect on patient's life
Measured: Weeks 0 to 24, patient visit weeks 0,2,4,8,12,16,20,24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start12 Jul 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontal Fibrosing 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
- Model description
- This is open label single side study involvement 20 patient treated with Apremilast. Each enrolled patient may be evaluated at by a dermatologist using the Lichen Planopilaris Activity Index and Frontal Fibrosing Alopecia Index. Other measures include physician global assessment, dermatology quality of life and patients analogue score for pruritus. Pt will have visits at Week 0,2,4,8,12,16,20,24
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bellevue Dermatology
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Principal investigator, Clive Liu, Bellevue Dermatology
- Investigators
- Clive Liu, MD, Study director, Bellevue Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422640
- Sponsor's protocol ID
- BD1-1
- Status last verified
- Jul 2018
- First submitted
- 23 Jan 2018
- Last updated
- 16 Jul 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Trial Evaluating the Efficacy of Apremilast for the Treatment of Frontal Fibrosing Alopecia
- ClinicalTrials.gov ID
- NCT03422640
- Acronym / sponsor ID
- BD1-1
- Conditions
- Frontal Fibrosing Alopecia
- Keywords
- Frontal Fibrosing Alopecia, Apremilast
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bellevue DermatologyUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- 12 Jul 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 6 Feb 2018 (actual)
- 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.
This is open label single side study involvement 20 patient treated with Apremilast. Each enrolled patient may be evaluated at by a dermatologist using the Lichen Planopilaris Activity Index and Frontal Fibrosing Alopecia Index. Other measures include physician global assessment, dermatology quality of life and patients analogue score for pruritus. Pt will have visits at Week 0,2,4,8,12,16,20,24
Detailed description
Frontal fibrosing alopecia (FFA) is a chronic immune mediated inflammatory disease characterized by inflammation of the hair follicle and scaring hair loss. Clinically, FFA presents as a progressive recession of the hairline in a frontal temporal distribution. Evidence suggests that timely and effective management can prevent the permanent loss of hair. Unfortunately, most current treatment have been disappointing with poor efficacy or high risk profile. The available of a safe effective treatment for this disease remains an unmet need Apremilast is a novel phosphodiesterase 4 inhibitor currently FDA approved to treat psoriasis and is under investigation for other auto immune conditions. The medication has a good safety profile with no required laboratory monitoring. This study primarily aimsto determine whether Apremilast offers any benefit for this difficult to treatment population
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is open label single side study involvement 20 patient treated with Apremilast. Each enrolled patient may be evaluated at by a dermatologist using the Lichen Planopilaris Activity Index and Frontal Fibrosing Alopecia Index. Other measures include physician global assessment, dermatology quality of life and patients analogue score for pruritus. Pt will have visits at Week 0,2,4,8,12,16,20,24
| Arm | Type | Receives |
|---|---|---|
| Treatment arm with apremilast | Experimental | Drug: ApremilastOpen label arm treating frontal fibrosing alopecia with apremilast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
- Male or Female and is at least 18 years of age, at the time of enrollment.
- Females of childbearing potential (FCBP)† must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive§ options described below: Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; 3. OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product.
- Patients with an established diagnosis of FFA based on the enrolling investigator's clinical judgment
- Patients who have been treated and failed one standard therapy including
Key exclusion criteria (10 listed)
- Other than disease under study, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
- Prior history of suicide attempt at any time in the subject's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
- Pregnant or breast feeding.
- Active substance abuse or a history of substance abuse within 6 months prior to Screening.
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 |
|---|---|---|
| ApremilastAlso: OtezlaOpen label treatment with apremilast | Drug | Treatment arm with apremilast |
Primary outcome
Lichen Planopilaris index
Time frame: Week 0 to 24, patient visit week0,2,4,8,12,16,20,24
The weights given to the symptoms (30%), signs (30%), anagen pull test (25%), and presence of spreading (15%) led to the equation: LPPAI (0-10) = (pruritus + pain + burning)/3 + (scalp erythema + perifollicular erythema + perifollicular scale)/3 + 2.5 (pull test) + 1.5 (spreading/2). Symptoms and signs are recorded on a 4-point scale. The anagen pull test involves grasping a small group of 10 to 20 hairs between the thumb, second finger, and third finger at the scalp end of the hair shafts, and pulling away from the scalp with a slow, firm perpendicular force to slide the fingers to the ends of the hair. The result is recorded both as a binary value (0 for no anagen hairs and 1 for the presence of anagen hairs) and as anagen hairs/total hairs pulled. Last is the assessment of spreading, recorded as 0 (no spreading) versus 1 (indeterminate) versus 2 (spreading). Our primary endpoint is percentage change from baseline
4 secondary outcomes
Physicians global assessment
Time frame: Weeks 0 to 24, patient visit week 0,2,4,8,12,16,20,24
Visual Analogue Scale Pruritus
Time frame: Weeks 0 to 24, patient visit week 0,2,4,8,12,16,20,24
Frontal Fibrosing Alopecia Index
Time frame: Weeks 0 to 24, patient visit weeks 0,2,4,8,12,16,20,24
Dermatology Quality of Life (DLQI) (Appendix E) Dermatology Quality of Life (DLQI) (Appendix E) Dermatology Quality of Life (DLQI)
Time frame: Weeks 0 to 24, patient visit weeks 0,2,4,8,12,16,20,24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Frontal Fibrosing Alopecia
Not yet recruitingPhase 2
Trial of Delgocitinib 20 mg/g Cream in Subjects With Frontal Fibrosing Alopecia (FFA)
Frontal Fibrosing Alopecia
Recruiting
Facial Papules in Frontal Fibrosing Alopecia (FFA)
Frontal Fibrosing Alopecia
RecruitingPhase 2
Deucravacitinib in the Treatment of Cicatricial Alopecias
Central Centrifugal Cicatricial Alopecia, Frontal Fibrosing Alopecia
Not yet recruitingObservational study
The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Frontal Fibrosing Alopecia in Routine Clinical Care: a Patient Preference Trial (FFA Trial)
Frontal Fibrosing Alopecia, Cicatricial Alopecia
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.
Clive Liu, MD study director
Bellevue Dermatology
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 Apremilast in people with Frontal Fibrosing Alopecia, run by Bellevue Dermatology 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 12 inclusion and 10 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 16 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.
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 Clive M Liu, MD (425-455-2275, Cliveliumd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lichen Planopilaris index (time frame: Week 0 to 24, patient visit week0,2,4,8,12,16,20,24). 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 16 Jul 2018.