Trial Outcomes & Findings for Apremilast in the Treatment of Central Centrifugal Cicatricial Alopecia (CCCA) (NCT NCT03521687)
NCT ID: NCT03521687
Last Updated: 2022-05-09
Results Overview
Mean change in PGA-I at Week 24 compared to Baseline. Trained study personnel will take standardized photographs of the scalp. These photographs will be provided to a panel of three dermatologists with expertise in CCCA, each of whom will review the photographs at these time points. Investigators will assess the improvement in hair loss severity using PGA-I. PGA-I will range from -3 (significant worsening) to 3 (significant improvement).
COMPLETED
PHASE4
20 participants
Week 0 and Week 24
2022-05-09
Participant Flow
Enrollment period from November 2018 to July 2020
Participant milestones
| Measure |
Apremilast
Patients with CCCA
Apremilast: 30 mg BID
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Apremilast
Patients with CCCA
Apremilast: 30 mg BID
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Apremilast in the Treatment of Central Centrifugal Cicatricial Alopecia (CCCA)
Baseline characteristics by cohort
| Measure |
Apremilast
n=20 Participants
Patients with CCCA
Apremilast: 30 mg BID
|
|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 11.11 • n=39 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Week 0 and Week 24Mean change in PGA-I at Week 24 compared to Baseline. Trained study personnel will take standardized photographs of the scalp. These photographs will be provided to a panel of three dermatologists with expertise in CCCA, each of whom will review the photographs at these time points. Investigators will assess the improvement in hair loss severity using PGA-I. PGA-I will range from -3 (significant worsening) to 3 (significant improvement).
Outcome measures
| Measure |
Apremilast
n=15 Participants
Patients with CCCA
Apremilast: 30 mg BID
|
|---|---|
|
Mean Change in Physician Global Assessment of Improvement (PGA-I)
|
0.07 score on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: Week 0 and Week 24Mean change in IGSS at Week 24 compared to Baseline. Treatment response will be considered no change or improvement in IGSS. CCCA Investigator Global Severity Score (IGSS) assess subjects on a scale of 0 (no hair loss) to 6 (severe CCCA, e.g. \>75% involvement of vertex).
Outcome measures
| Measure |
Apremilast
n=15 Participants
Patients with CCCA
Apremilast: 30 mg BID
|
|---|---|
|
Mean Change in CCCA Investigator Global Severity Score (IGSS)
|
-0.31 score on a scale
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: Week 0 and week 24Mean change in CHLG at Week 24 compared to Baseline. Degree of severity of hair loss is graded on a 6-point visual scale (pattern 0: no hair loss, pattern 1-2: mild hair loss, pattern 3-5: more severe hair loss).
Outcome measures
| Measure |
Apremilast
n=15 Participants
Patients with CCCA
Apremilast: 30 mg BID
|
|---|---|
|
Mean Change in Central Hair Loss Grade (CHLG)
|
-0.44 score on a scale
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Week 0 and Week 24Mean change in VAS at Week 24 compared to Baseline. The VAS is a numerical scale used to assess patients' perception of hair loss severity. The evaluation is a 10cm long line on which the subjects indicate the severity of their condition from "0" (complete loss of hair in affected area - ie no visible hairs on central scalp) to "10" (full growth/regrowth in affected area-ie no visible hair loss on central scalp).
Outcome measures
| Measure |
Apremilast
n=15 Participants
Patients with CCCA
Apremilast: 30 mg BID
|
|---|---|
|
Mean Change in Subject Visual Analog Scale (VAS) of Hair Loss Severity
|
-1.94 score on a scale
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: Week 0 and Week 24Mean change in PaGA-I at Week 24 as compared to Baseline. PaGA-I will range from -3 (significant worsening) to 3 (significant improvement).
Outcome measures
| Measure |
Apremilast
n=15 Participants
Patients with CCCA
Apremilast: 30 mg BID
|
|---|---|
|
Mean Change in Subject Global Assessment of Improvement
|
1 score on a scale
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: Week 0 and Week 24Change in NRS at Week 24 as compared to Baseline. Subjects will complete a symptom severity questionnaire consisting of 3 numeric rating scales (NRS) measuring severity of pruritus, burning, and pain. The NRS will range from 0 (no symptoms) to 10 (severe symptoms). Patients indicate the intensity of each symptom (pruritus, burning, or pain) by choosing a number from 0 to 10 that corresponds to the severity of that symptom.
Outcome measures
| Measure |
Apremilast
n=15 Participants
Patients with CCCA
Apremilast: 30 mg BID
|
|---|---|
|
Change in Subject Rating of Symptom Severity Questionnaire (NRS)
|
0.94 score on a scale
Standard Deviation 3.99
|
SECONDARY outcome
Timeframe: Week 0 and Week 24Mean change in DLQI total score at Week 24 as compared to Baseline. DLQi is a 10-item questionnaire, each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Outcome measures
| Measure |
Apremilast
n=15 Participants
Patients with CCCA
Apremilast: 30 mg BID
|
|---|---|
|
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
|
-2.18 score on a scale
Standard Deviation 3.79
|
Adverse Events
Apremilast
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Apremilast
n=20 participants at risk
Patients with CCCA
Apremilast: 30 mg BID
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
5/20 • 24 weeks
|
|
Gastrointestinal disorders
Flatulence
|
15.0%
3/20 • 24 weeks
|
|
Gastrointestinal disorders
Reflux
|
10.0%
2/20 • 24 weeks
|
|
Nervous system disorders
Headache
|
25.0%
5/20 • 24 weeks
|
|
Gastrointestinal disorders
Loose stools
|
25.0%
5/20 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
15.0%
3/20 • 24 weeks
|
|
Psychiatric disorders
Depression
|
15.0%
3/20 • 24 weeks
|
|
General disorders
Decreased appetite
|
25.0%
5/20 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
4/20 • 24 weeks
|
|
General disorders
Weight Loss
|
15.0%
3/20 • 24 weeks
|
|
Infections and infestations
Common cold
|
10.0%
2/20 • 24 weeks
|
|
Infections and infestations
Upper respiratory infection
|
15.0%
3/20 • 24 weeks
|
|
General disorders
Tiredness
|
10.0%
2/20 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • 24 weeks
|
|
Gastrointestinal disorders
Increased bowel movements
|
25.0%
5/20 • 24 weeks
|
|
Infections and infestations
Covid like illness
|
15.0%
3/20 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Increased hair loss
|
10.0%
2/20 • 24 weeks
|
|
General disorders
Nasal congestion
|
5.0%
1/20 • 24 weeks
|
|
General disorders
Cracked tooth
|
5.0%
1/20 • 24 weeks
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Lower back muscle strain
|
5.0%
1/20 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
left knee pain
|
5.0%
1/20 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Itchy scalp
|
5.0%
1/20 • 24 weeks
|
|
General disorders
Seasonal allergies
|
5.0%
1/20 • 24 weeks
|
|
General disorders
Sinus headache
|
5.0%
1/20 • 24 weeks
|
|
Psychiatric disorders
Hair breakage
|
5.0%
1/20 • 24 weeks
|
|
General disorders
Sinusitis
|
5.0%
1/20 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
5.0%
1/20 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Worsening urticaria
|
5.0%
1/20 • 24 weeks
|
|
Nervous system disorders
Intention tremor
|
5.0%
1/20 • 24 weeks
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Subjective PIH
|
5.0%
1/20 • 24 weeks
|
|
Psychiatric disorders
Hyperactivity
|
5.0%
1/20 • 24 weeks
|
|
Reproductive system and breast disorders
Abnormal mammogram
|
5.0%
1/20 • 24 weeks
|
|
General disorders
Post nasal drip
|
5.0%
1/20 • 24 weeks
|
|
Reproductive system and breast disorders
Irregular periods
|
5.0%
1/20 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
5.0%
1/20 • 24 weeks
|
|
Eye disorders
Eye Infection
|
5.0%
1/20 • 24 weeks
|
Additional Information
Ingrid Sanabria-Gonzalez
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place