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

NCT07783165 | Not Yet Recruiting

• 1 other identifier: DLPF-03
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

28 Day Survey study in patients with Ichthyosis

Conditions

Ichthyosis

Keywords

Doublebase Once; Treatment; Ichthyosis

Outcome Measures

Primary Outcomes (1)

• Questionnaire responses

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

  4 weeks

Study Arms (1)

single arm study in approximately 100 Ichthyosis patients of any age.

EXPERIMENTAL

Open label

Device: Doublebase Once

Interventions

Doublebase Once DEVICE

Single daily use Emollient

single arm study in approximately 100 Ichthyosis patients of any age.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• Patients (or their parents/legal guardians, in the case of infants, very young children or adolescent adults) who may have difficulties completing the feedback questionnaires, which will be written in English only.
• Employees of the Sponsor (Dermal or the Diomed group companies), or any immediate family member (partner, offspring, parents, siblings or sibling's offspring) of such employees

Sponsors & Collaborators

• Dermal Laboratories Ltd: lead

MeSH Terms

Conditions

Ichthyosis

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm, open label

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: September 7, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Jan 2027
• Access Criteria: This registry and Publications