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Phosphodiesterase 4 (PDE4) Inhibitor

Treatment arm with apremilast for Hair Loss

Phase 4
Waitlist Available
Research Sponsored by Bellevue Dermatology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 to 24, patient visit week0,2,4,8,12,16,20,24
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

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

Eligible Conditions
  • Hair Loss

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 to 24, patient visit week0,2,4,8,12,16,20,24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 to 24, patient visit week0,2,4,8,12,16,20,24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Lichen Planopilaris index
Secondary study objectives
Dermatology Quality of Life (DLQI) (Appendix E) Dermatology Quality of Life (DLQI) (Appendix E) Dermatology Quality of Life (DLQI)
Frontal Fibrosing Alopecia Index
Physicians global assessment
+1 more

Side effects data

From 2018 Phase 4 trial • 20 Patients • NCT03000309
30%
diarrhea
30%
nausea
25%
headache
15%
abdominal cramping
15%
upset stomach, unspecified
10%
heartburn
5%
viral gastroenteritis
5%
cyst left inner thigh
5%
abscess right hand
5%
right flank pain
5%
irritability
5%
leg cramps
5%
upper respiratory infection
5%
otitis externa
100%
80%
60%
40%
20%
0%
Study treatment Arm
Apremilast

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment arm with apremilastExperimental Treatment1 Intervention
Open label arm treating frontal fibrosing alopecia with apremilast
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apremilast
FDA approved

Find a Location

Who is running the clinical trial?

CelgeneIndustry Sponsor
645 Previous Clinical Trials
130,420 Total Patients Enrolled
Bellevue DermatologyLead Sponsor
Clive Liu, MDStudy DirectorBellevue Dermatology
~3 spots leftby Nov 2025
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