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TerminatedNCT00996008Updated Oct 26, 2010

CT 327 in the Treatment of Atopic Dermatitis

A Phase 2 interventional study of placebo and CT 327 in Mild to Moderate Atopic Dermatitis, sponsored by Creabilis SA. Terminated at 5 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-10-26.

Sponsored by Creabilis SA · Phase 2, Interventional, and Treatment

Why this study was terminated
Due to slow recruitment, study was stopped before target enrollment was achieved
Phase
Phase 2
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will look at how safe and effective, a novel agent, CT 327 cream is in treating patients with mild to moderate atopic dermatitis (AD). Patients will be treated twice daily for 14 days on specific lesions of AD and safety and symptoms of AD will be assessed throughout the treatment period.

02

Conditions studied

  • Mild to Moderate Atopic Dermatitis
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 15 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Creabilis SA is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male and Female subjects aged >18 year
  • Written informed consent
  • Mild to moderate AD at baseline (EASI score of at least 2 or 3)
  • Active AD (visible eczema, erythema and pruritus)
  • Presence of at least four target lesions (symmetrically) at inclusion (ideally at the elbow flexions and knee bends)

Exclusion criteria

Exclusion Criteria:

  • If female of childbearing potential not using an adequate and appropriate form of contraception such as oral contraceptive; intra-uterine device (IUD); contraceptive injection, implant or patch
  • If female, are pregnant or lactating, or intend to become pregnant during the study period
  • Allergy to test drug or excipients
  • Usage of topical corticosteroids or other topical treatments for AD within the last two weeks prior to study entry (including calcineurin inhibitor, topical H1 and H2 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment
  • Within 4 weeks prior to study entry, have received systemic treatment for atopic dermatitis (including systemic corticosteroids, nonsteroidals, immunosuppressants, or immunomodulating drugs, or treatment with light).
  • Presence of major medical illness requiring systemic therapy including cancers
  • Clinical diagnosis of bacterial infection of the skin including impetigo and abscesses
  • Any clinical relevant ECG abnormality
  • Have any clinically significant abnormal clinical laboratory test results at screening
  • Received any investigational drug or taking part in any clinical study within three months prior to this study
  • History of drug, alcohol or other substance abuse or other factors limiting the ability to co-operate and to comply with this protocol
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Placebo comparator
    Placebo only

    Subjects will apply placebo cream to all 4 target lesions

    Drug: placebo

  • Active comparator
    Active plus placebo

    Subjects will receive CT 327 on 2 of 4 target lesions located on one side of their body. On the remaining 2 target lesions on the other side of their body, placebo will be applied.

    Drug: CT 327

Interventions

  • Drugplacebo

    0.5 g (w/w) placebo cream applied to each target lesion twice daily

  • DrugCT 327

    0.5 g CT 327 cream will be applied to 2 target lesions twice daily 0.5 g placebo cream will be applied to remaining 2 target lesions twice daily

06

What researchers measure

Primary outcomes

  1. To assess the efficacy of CT 327 vs Placebo in terms of improvements from baseline on Modified Eczema Area Severity Index (mEASI) score: Proportion of subjects with a reduction in mEASI-score of ≥ 50% on day 14

    Time frame: 14 days

Secondary outcomes

  1. To assess the efficacy of a 14-days treatment of CT 327 vs Placebo in terms of improvements from baseline on: Proportion of subjects with a reduction in m-EASI-score of > 75% on day 14

    Time frame: 14 days

07

Study locations

5 sites
  • University Hospital
    Basel, 4031, Switzerland
  • Inselspital
    Bern, CH-3010, Switzerland
  • CHUV, Hôpital de Beaumont
    Lausanne, CH-1011, Switzerland
  • Kantonsspital St Gallen
    St Gallen, CH-9007, Switzerland
  • University Hospital
    Zürich, CH-8091, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00996008
Lead sponsor
Creabilis SA
First posted
Oct 16, 2009
Start date
Nov 2009
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Oct 26, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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