IchthyosisPhase 3NCT00004690
Phase III Study of Monolaurin Cream Therapy for Patients With Congenital Ichthyosis
A Phase 3 study testing monolaurin cream in people with Ichthyosis, run by Cellegy Pharmaceuticals.
Trial summary
OBJECTIVES: I. Compare the safety and efficacy of monolaurin cream versus a placebo vehicle cream in suppressing the signs of nonbullous congenital ichthyosiform erythroderma. II. Assess the incidence of posttreatment rebound or recrudescence in patients with congenital ichthyosis. III. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Ichthyosis
- What is being tested?
- monolaurin cream
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Sep 1996to Sep 1998
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Nonbullous congenital ichthyosiform erythroderma (chronic, multifactorial, hyperkeratotic, inflammatory skin disease) Clinical criteria includes: - generalized involvement with no flexural sparing - congenital onset usually as collodion baby (i.e., a taut, shiny encasement which is shed postnatally revealing underlying erythroderma and generalized ichthyosis) - scales should be fine, whitish, and rather loose except on the lower legs where the scales may be large, platelike, and dark - if severely effected: intense erythema is present; overt ectropion may be present; cicatricial alopecia may be present; and secondary nail dystrophies with thickening of nail plate and ridging may be present
- Phenotypically consistent with diagnostic grading photos
- Grade of at least 3 for scaling on four treatment sites
--Prior/Concurrent Therapy--
- Biologic therapy: Not specified
- Chemotherapy: Not specified
- Endocrine therapy: At least 4 weeks since prior corticosteroids No concurrent corticosteroids
- Radiotherapy: Not specified
- Surgery: Not specified
- Other: At least 4 weeks since any prior investigational medications At least 4 weeks since any prior systemic therapy, such as hypolipidemics or retinoids Nonglycerin emollients allowed up to 1 week prior to study At least 4 weeks since any other topical therapy including humectants such as urea, alpha hydroxy or alpha ketoacid preparations and retinoids No concurrent topical therapy No concurrent investigational medications
--Patient Characteristics--
- Age: 18 months and over
- Performance status: Not specified
- Hematopoietic: No clinically significant laboratory abnormalities
- Hepatic: No clinically significant laboratory abnormalities
- Renal: No clinically significant laboratory abnormalities
- Other: Triglyceride or total cholesterol no greater than 3 times normal Must be in general good health No known hypersensitivity to any component of this study medication Not pregnant or nursing Adequate contraception required of all fertile women
About this study
OBJECTIVES: I. Compare the safety and efficacy of monolaurin cream versus a placebo vehicle cream in suppressing the signs of nonbullous congenital ichthyosiform erythroderma.
II. Assess the incidence of posttreatment rebound or recrudescence in patients with congenital ichthyosis.
III. Evaluate the long term safety of monolaurin cream with whole body application in these patients.
Read the detailed description
PROTOCOL OUTLINE: This is a three month, randomized, double blind, placebo controlled study followed by a nine month, open label, rollover study.
Patients are treated either with a placebo vehicle cream or the study cream, monolaurin (15% glyceryl monolaurate), for 3 months followed by a four week break. Medications are applied uniformly twice daily (morning and at least 1 hour before bedtime). After this blinded portion of the study, all patients are administered monolaurin cream for 9 months.
Patients are followed for 4 weeks after the last cream application.
Completion date provided represents the completion date of the grant per OOPD records
- Conditions
- Ichthyosis
- Being tested
- monolaurin cream
- Keywords
- dermatologic disorders, ichthyosis, rare disease
- Medical subject headings
- Ichthyosis, Skin Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monolaurin creamDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startSep 1996
- Study completionSep 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IchthyosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Cellegy Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carl R. Thornfeldt, Study chair, Cellegy Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004690
- Sponsor's protocol ID
- 199/13316
- Other IDs
- CELLEGY-FDR001278
- Status last verified
- Mar 1999
- First submitted
- 24 Feb 2000
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Monolaurin Cream Therapy for Patients With Congenital Ichthyosis
- ClinicalTrials.gov ID
- NCT00004690
- Acronym / sponsor ID
- 199/13316
- Conditions
- Ichthyosis
- Keywords
- dermatologic disorders, ichthyosis, rare disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- Cellegy PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 1996
- Study completion
- Sep 1998
- First posted
- 25 Feb 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES: I. Compare the safety and efficacy of monolaurin cream versus a placebo vehicle cream in suppressing the signs of nonbullous congenital ichthyosiform erythroderma.
II. Assess the incidence of posttreatment rebound or recrudescence in patients with congenital ichthyosis.
III. Evaluate the long term safety of monolaurin cream with whole body application in these patients.
Detailed description
PROTOCOL OUTLINE: This is a three month, randomized, double blind, placebo controlled study followed by a nine month, open label, rollover study.
Patients are treated either with a placebo vehicle cream or the study cream, monolaurin (15% glyceryl monolaurate), for 3 months followed by a four week break. Medications are applied uniformly twice daily (morning and at least 1 hour before bedtime). After this blinded portion of the study, all patients are administered monolaurin cream for 9 months.
Patients are followed for 4 weeks after the last cream application.
Completion date provided represents the completion date of the grant per OOPD records
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| monolaurin cream | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl R. Thornfeldt study chair
Cellegy Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing monolaurin cream in people with Ichthyosis, run by Cellegy Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.