Trial Comparing Calmoseptine Ointment and Desitin Diaper Rash Paste in Diaper Dermatitis in Neonates and Infants

NCT02716415 | Completed Phase 4

• 1 other identifier: 2015-019-01
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy and safety of Calmoseptine Ointment and Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste in the treatment of diaper dermatitis among Neonates and Infants.

Conditions

Diaper Dermatitis

Keywords

neonates; infants

Outcome Measures

Primary Outcomes (1)

• Healing of diaper Dermatitis

  Complete healing of Diaper Dermatitis on final study day, as determined by Diaper Dermatitis Severity Scale. Possible score range from zero (0 - clear skin) ti six (6 - severe erythema, all or most of the diaper area affected, with papules and/or pustules, and open skin affecting the dermis). Complete healing is defined as a Diaper Dermatitis Severity Score of zero (0). Assessment of the primary outcome used in final analyses will be blinded. For determination of final trial results for the primary outcome, sets of high definition photographs for each patient on each treatment day will be assessed by independent wound, Ostomy and Continence Nursing Certification Board (WOCNB) certified wound care expert assessors based in the USA, who are blinded to treatment allocation, not involved in the study.

  Assessed on Final day of data collection (Day 6)

Secondary Outcomes (1)

• Daily Diaper Dermatitis Severity Score

  Assessed on Day 0, 1, 2, 3, 4, 5, and 6

Other Outcomes (2)

• Size of area affected by diaper dermatitis on Days 0-6.

  Measured on Day 0, 1, 2, 3, 4, 5, and 6

• Adverse Events.

  Recorder on Day 0, 1, 2, 3, 4, 5, and 6

Study Arms (2)

Calmoseptine Ointment

ACTIVE COMPARATOR

Calmoseptine Ointment as part of a structured skin care regimen.

Drug: Calmoseptine Ointment

Destin Maximum Strength 40% Zinc

ACTIVE COMPARATOR

Destin Maximum Strength 40% Zinc as part of a structured skin care regimen.

Drug: Destin Maximum Strength 40% Zinc

Interventions

Calmoseptine Ointment DRUG

A full structured skin care regimen is provided in a consistent fashion either by study personnel or by the participant's primary carer (family or ward staff) at each diaper change. Study nurse sub-investigator visit each participant twice per nursing shift (six times per day) either to deliver the care regimen or to observe that it is being delivered. The regimen includes: * regular diaper changing, * gentle cleansing * application of the trial ointment

Also known as: Calmoseptine

Calmoseptine Ointment

Destin Maximum Strength 40% Zinc DRUG

A full structured skin care regimen is provided in a consistent fashion either by study personnel or by the participant's primary carer (family or ward staff) at each diaper change. Study nurse sub-investigator visit each participant twice per nursing shift (six times per day) either to deliver the care regimen or to observe that it is being delivered. The regimen includes: * regular diaper changing, * gentle cleansing * application of the trial ointment

Also known as: Destin

Destin Maximum Strength 40% Zinc

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The child participant must be \< 1 year of age.
• The participant must, upon clinical inspection by an investigator, be assessed to have diaper dermatitis ≥ Grade 2 according to the study's diaper dermatitis severity scale (see "Primary Outcome").
• There is a reasonable expectation that the participant will be hospitalized for at least 7 days and will be able to complete the study. (NB Study Participant Withdrawal Criteria b - Any participants discharged from hospital by their attending physician before completion of study participation will automatically be withdrawn from the study. Study participation will not under any circumstances lead to delay in a participant's discharge from hospital.)
• Participant has no known allergy or history of adverse reaction to any of the ingredients in either product or to any topical preparations or skin care products

You may not qualify if:

• Participants with a pre-existing full thickness wound within the study area.
• Participants with pre-existing active dermatological condition(s), other than DD, which may affect healing or interpretation of trial results. Where uncertainty exists, the Investigators will arrange a consultation with a Consultant Dermatologist.
• Participant has a history of recurrent dermatological conditions, other than DD, that may imply difficult healing or affect interpretation of trial results.
• Participant has any severe acute or chronic medical condition such that trial participation may constitute a risk, or may interfere with their medical care, or affect interpretation of results, or their attending physician advises against participation.
• Participant is on systemic antifungal treatment (eg. Amphotericin B or Fluconazole), topical antifungal treatment and / or systemic or topical corticosteroids.
• Participant has in the preceding week been treated with topical agents that may affect healing (e.g. dimethicone based ointments, zinc oxide powder, petroleum jelly)

Sponsors & Collaborators

• University of the Philippines: lead
• Calmoseptine, Inc.: collaborator

Study Sites (1)

Philippine General Hospital - University of the Philippines, Manila

Manila, National Capital Region, 1000, Philippines

Location

MeSH Terms

Conditions

Diaper Rash

Interventions

Zinc

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Jacinto Blas Mantaring, MD

  Department of Pediatrics, Philippine General Hospital UP Manila

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 23, 2016
• Study Start: March 1, 2015
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)