Phase 3
N=596
Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema
Eczema
Bottom Line
View on ClinicalTrials.gov: NCT00817063 ↗Enrolled (actual)
596
Serious AEs
1.7%
Results posted
Nov 2017
Primary outcome: Primary: Number of Participants Who Responded as Per Physician's Global Assessment (PGA) at Week 24 — 58; 14; 60; 30 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- alitretinoin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stiefel, a GSK Company
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Responded as Per Physician's Global Assessment (PGA) at Week 24 |
58; 14; 60; 30; 118; 44 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Modified Total Lesion Symptom Score (mTLSS) at the End-of-treatment |
-53.99; -29.86 | <0.001 sig |
| SECONDARY Number of Participants Who Responded as Per Patient Global Assessment (PaGA) at End-of-treatment |
117; 41 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Extent of Disease at End-of-treatment |
-46.56; -24.20 | <0.001 sig |
| SECONDARY Response Duration for Responding Participants at the End-of-therapy |
8.3; 16.9 | 0.047 sig |
| SECONDARY Time to Relapse for Responding Participants at the End-of-therapy |
83.0; NA | 0.068 |
| SECONDARY Time to Response for Responding Participants at End-of-therapy |
65.0; 117.0 | <0.001 sig |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period |
216; 155; 7; 3 | — |
| SECONDARY Number of Participants With Maximum Post Baseline Laboratory Values Outside the Marked Reference Range |
8; 6; 17; 8; 1; 1 | — |
| SECONDARY Number of Participants Referred or Not Referred to a Psychiatrist as Per Brief Summary Inventory (BSI) 53 Questionnaire up to 24 Weeks |
47; 34; 14; 24; 19; 10 | — |
| SECONDARY Change From Baseline in Patient Health Questionnaire (PHQ-9) Score Over 28 Weeks |
-0.3; -0.2; -0.6; -0.6; -0.9; -0.9 | — |
| SECONDARY Number of Participants Meeting the Referral Criteria of Psychiatric Evaluation Over 28 Weeks |
2; 0; 3; 2; 3; 3 | — |
| SECONDARY Change From Baseline in Hearing Handicap Inventory for the Elderly-Screening (HHIE-S) Over 24 Weeks |
-0.0; -0.2; -0.1; -0.1; -0.2; -0.1 | — |
| SECONDARY Change From Baseline in Dizziness Handicap Inventory (DHI) Over 24 Weeks |
-0.3; 0.3; -0.5; -0.1; -0.2; -0.1 | — |
| SECONDARY Number of Participants Responding to Tinnitus Ototoxicity Monitoring Interview (TOMI) Questionnaire Over 24 Weeks |
16; 5; 11; 2; 3; 0 | — |
| SECONDARY Percent Change From Baseline in Bone Mineral Density (BMD) by Dual Energy X-ray Absorptiometry (DXA) Over 72 Weeks |
0.385; -0.104; 0.435; -0.063 | 0.179 |
| SECONDARY Number of Participants With Adequecy of Images Assessed by X-ray Evaluation of Bones |
73; 85; 171; 158; 229; 234 | — |
| SECONDARY Number of Participants With Adverse Ophthalmological Change as Assessed by Fundus Photography - Intraocular Pressure |
152; 146; 0; 1; 28; 39 | — |
| SECONDARY Number of Participants With Adverse Audiological Change as Assessed by Puretone Audiogram at Highest Frequency |
131; 125; 4; 10; 14; 12 | — |
Summary
The purpose of this study is to investigate the safety and efficacy of alitretinoin in the treatment of severe chronic hand eczema that does not respond to treatment with potent topical steroids.
Eligibility Criteria
Inclusion Criteria
- all types of chronic hand eczema, lasting for at least 6 months since initial diagnosis
- rated as severe by the physician
- unresponsive to highly potent topical corticosteroids, such as clobetasol
Exclusion Criteria
- patients whose disease is adequately controlled by standard non-medicated therapy, including potent topical steroids, skin moisturizers, and avoidance of allergens and irritants
- patients with known allergens and irritants, who have not made a reasonable effort to avoid the substances
- patients with psoriasis lesions
- active fungal, bacterial or viral infections of the hands
- female patients who are pregnant or breastfeeding
- female patients of childbearing potential who cannot use or will not commit to use two effective methods of contraception
Data sourced from ClinicalTrials.gov (NCT00817063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.