Patient Study to Evaluate the Safety and Emollient Performance of Doublebase Once in the Treatment of Ichthyosis

ConditionIchthyosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorDermal Laboratories Ltd

About this trial

28 Day Survey study in patients with Ichthyosis

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with ichthyosis of any severity previously diagnosed by a Healthcare Professional (HCP).

Patients normally managing their skin condition by regular and ongoing use of leave-on emollient(s).

Patients willing to use Doublebase Once for one month, instead of the patients usual emollient, as part of their normal ichthyosis management for the area(s) they have selected to treat for the study? This would also involve trying to use it once daily only

Disqualifiers

Does not regularly use an emollient

Known history of intolerance or skin sensitivity to any of the ingredients of Doublebase Once (as identified on the Patient Information Sheet and product labelling), or similar products used.

Currently participating in a study involving an investigational medicinal product/medical device or having participated in the previous 30 days.

Patients currently residing in Northern Ireland (this is due to the different approval process).

Trial design

Design model

Single group

Treatments tested in this trial

  • Doublebase Once

    Device

    Single daily use Emollient

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: single arm study in approximately 100 Ichthyosis patients of any age.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Questionnaire responses

Skin condition changes from baseline parameters scores 0-10 (0 = strongly agree, 10 = Strongly disagree) and product use questionnaires

Time frame
4 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: