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Trial Evaluating the Efficacy of Apremilast for the Treatment of Frontal Fibrosing Alopecia

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ClinicalTrials.gov Identifier: NCT03422640
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Clive Liu, Bellevue Dermatology

Brief 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. 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

Condition or disease Intervention/treatment Phase
Frontal Fibrosing Alopecia Drug: Apremilast Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Open Label Trial Evaluating the Efficacy of Apremilast for the Treatment of Frontal Fibrosing Alopecia
Estimated Study Start Date : July 12, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Apremilast

Arm Intervention/treatment
Experimental: Treatment arm with apremilast
Open label arm treating frontal fibrosing alopecia with apremilast
Drug: Apremilast
Open label treatment with apremilast
Other Name: Otezla




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Physicians global assessment [ Time Frame: Weeks 0 to 24, patient visit week 0,2,4,8,12,16,20,24 ]
    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

  2. Visual Analogue Scale Pruritus [ Time Frame: Weeks 0 to 24, patient visit week 0,2,4,8,12,16,20,24 ]
    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.

  3. Frontal Fibrosing Alopecia Index [ Time Frame: Weeks 0 to 24, patient visit weeks 0,2,4,8,12,16,20,24 ]
    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

  4. 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 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. Male or Female and is at least 18 years of age, at the time of enrollment.
  3. 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).
  4. Patients with an established diagnosis of FFA based on the enrolling investigator's clinical judgment
  5. Patients who have been treated and failed one standard therapy including

    • Topical steroids
    • Short course systemic steroids
    • Systemic antibiotics
  6. Patients who are on stable dose of topical steroids or systemic antibiotics
  7. 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.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Pregnant or breast feeding.
  5. Active substance abuse or a history of substance abuse within 6 months prior to Screening.
  6. 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.
  7. Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
  8. Prior treatment with apremilast.
  9. Patient who have underlying chronic infections including HIV, Hep B and C.
  10. History of uncontrolled depression.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422640


Contacts
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Contact: Clive M Liu, MD 425-455-2275 Cliveliumd@gmail.com
Contact: Ivy T Chan, BA 510-332-4783 Gcpchan@aol.com

Locations
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United States, Washington
Bellevue Dermatology Recruiting
Bellevue, Washington, United States, 98004
Contact: Clive M Liu, MD    425-455-2275    Cliveliumd@gmail.com   
Sponsors and Collaborators
Bellevue Dermatology
Celgene
Investigators
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Study Director: Clive Liu, MD Bellevue Dermatology

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Responsible Party: Clive Liu, Director, Bellevue Dermatology
ClinicalTrials.gov Identifier: NCT03422640     History of Changes
Other Study ID Numbers: BD1-1
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Clive Liu, Bellevue Dermatology:
Frontal Fibrosing Alopecia
Apremilast
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Thalidomide
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents