18 and older, female only, with Central Centrifugal Cicatricial Alopecia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Change in Physician Global Assessment of Improvement (PGA-I)Primary· Week 0 and Week 24
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).
Group
Value
95% CI
Apremilast
0.07
± 0.51
Mean Change in CCCA Investigator Global Severity Score (IGSS)Secondary· Week 0 and Week 24
Mean 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).
Group
Value
95% CI
Apremilast
-0.31
± 0.65
Mean Change in Central Hair Loss Grade (CHLG)Secondary· Week 0 and week 24
Mean 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).
Group
Value
95% CI
Apremilast
-0.44
± 0.86
Mean Change in Subject Visual Analog Scale (VAS) of Hair Loss SeveritySecondary· Week 0 and Week 24
Mean 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).
Group
Value
95% CI
Apremilast
-1.94
± 1.86
Mean Change in Subject Global Assessment of ImprovementSecondary· Week 0 and Week 24
Mean change in PaGA-I at Week 24 as compared to Baseline. PaGA-I will range from -3 (significant worsening) to 3 (significant improvement).
Group
Value
95% CI
Apremilast
1
± 1.45
Change in Subject Rating of Symptom Severity Questionnaire (NRS)Secondary· Week 0 and Week 24
Change 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.
Group
Value
95% CI
Apremilast
0.94
± 3.99
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total ScoreSecondary· Week 0 and Week 24
Mean 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).
Group
Value
95% CI
Apremilast
-2.18
± 3.79
Adverse events — posted to ClinicalTrials.gov
Time frame: 24 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a single-center, open-label clinical study to study the efficacy of apremilast in the treatment of mild to moderate central centrifugal cicatricial alopecia. The investigators hypothesize that the anti-inflammatory properties of apremilast may play a role in the decreasing scalp inflammation in patients with CCCA and may prevent further hair loss and potentially induce hair regrowth in patients with mild to moderate disease.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07398651 — Apremilast and Adalimumab in Psoriatic Arthritis Patients
· NA
· not yet recruiting
NCT07325266 — Human Laboratory Study of Apremilast for Alcohol Use Disorder
· Phase 2
· recruiting
NCT07432386 — Methotrexate Versus Apremilast for Pruritus in Psoriasis
· Phase 4
· not yet recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
· Phase 4
· not yet recruiting
NCT07337434 — To Check Comparison of Apremilast and Methotrexate Efficacy in Patients With Moderate to Severe Plaque Psoriasis Present
· EARLY_PHASE1
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai
Last refreshed: 9 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03521687.