Pimecrolimus 1% vs Placebo for Facial Vitiligo: Randomized Controlled Trial Overview

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Key Takeaways

  • Pimecrolimus 1% cream showed superiority to vehicle on facial endpoints (F-VASI) over ~12–24 weeks in split-face and parallel-arm RCTs.
  • Best responses on periorificial areas (eyelids, perioral); acral lesions remain comparatively refractory.
  • Safety profile favorable: no skin atrophy, most AEs mild/transient burning or erythema.
  • Combination with NB-UVB or excimer 308 nm increases speed and magnitude of repigmentation.

Abstract

Randomized, double-blind studies comparing pimecrolimus 1% cream to vehicle in facial vitiligo demonstrate statistically and clinically meaningful improvements on F-VASI and physician global assessments over 12–24 weeks, with excellent tolerability and utility as a steroid-sparing option for cosmetically sensitive areas.

Trial Design

Table 1. Core design elements.
Element Details
Type Randomized, double-blind, vehicle-controlled; split-face and parallel-arm variants
Duration 12–24 weeks controlled phase; optional extension
Masking Participants, investigators, assessors
Setting Dermatology clinics; standardized photography and Wood’s lamp mapping

Participants & Baseline

Table 2. Eligibility and baseline notes.
Category Criteria/Notes
Inclusion Facial nonsegmental vitiligo; minimal F-VASI threshold; age ≥2–12 (peds subsets) or ≥12–18+ (adolescents/adults)
Exclusion Recent systemic immunosuppressants; photosensitivity disorders
Baseline Periorificial and cheek lesions common; mixed phototypes

Interventions & Dosing

Table 3. Regimens.
Arm Regimen Notes
Pimecrolimus 1% cream Thin layer BID to facial lesions Apply after emollient if stinging
Vehicle (placebo) Matched schedule Rescue allowed per protocol
Optional co-therapy NB-UVB or excimer 308 nm Protocolized in some RCT arms

Endpoints

  • Primary: Change in F-VASI at week 12–24 (or responder thresholds F-VASI50/75).
  • Secondary: Physician/Patient Global, time to first perifollicular islands, quality-of-life scales.
  • Exploratory: Wood’s lamp margin contraction; photo-composite scoring.

Efficacy Results

Pimecrolimus 1% outperformed vehicle on facial endpoints, with earliest visible changes around weeks 4–8 (perifollicular islands) and continued gains through week 12–24. Combination with NB-UVB/excimer accelerated response.

Table 4. Outcome framework (populate with study numerics).
Outcome Pimecrolimus 1% Vehicle Interpretation
F-VASI % change (wk 12–24) — — Favours pimecrolimus
F-VASI50/75 responders — — Higher on active
Time to islands (weeks) Earlier Later Predicts endpoint
QoL improvement — — Supports patient-reported benefit

Safety

Table 5. Adverse events.
Event Pattern Management
Burning/tingling Mild, transient at initiation Emollients; step-down to QD
Erythema/irritation Occasional Brief pause; re-titrate
Cutaneous atrophy Not expected Calcineurin inhibitor advantage

No skin atrophy or telangiectasia observed; suitable for long-term facial use versus topical corticosteroids.

Pediatric Notes

  • Well-tolerated in children on periorificial areas; emphasize adherence and sun protection.
  • Consider NB-UVB/excimer adjunction for faster response in older children/adolescents.

Limitations

Sample sizes modest; heterogeneity in endpoints and adjunct light use; long-term off-drug durability limited.

References

  1. Randomized, double-blind split-face and parallel-arm trials of pimecrolimus 1% vs vehicle in facial vitiligo.
  2. Adjunct phototherapy studies (NB-UVB, excimer 308 nm) with calcineurin inhibitors.
  3. Guidelines on calcineurin inhibitor use for periorificial/facial dermatoses.
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