Comparison of 12% Ammonium Lactate and 10% Urea Cream in Geriatric With Xerosis Cutis

NCT04127513 | Completed Phase 3

• 1 other identifier: ThesisEyleny
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy and safety between moisturizing cream containing 12% ammonium lactate and 10% urea in geriatric with xerosis cutis. A double-blind randomized controlled trial with matching paired subject was conducted on 40 residents of a nursing home in Jakarta. Specified symptom sum score (SRRC), skin capacitance (SCap), transepidermal water loss (TEWL), and side effects were measured at baseline, week-2 and week-4 after therapy, and week-5 one week after therapy cessation. After a week of preconditioning, each subject received two different moisturizing creams to be applied on separate lower limbs.

Conditions

Xerosis Cutis

Keywords

xerosis cutis; geriatric; 12% ammonium lactate; 10% urea

Outcome Measures

Primary Outcomes (15)

• First Evaluation of Specified Symptom Sum Score (SRRC)

  System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed before therapy.

  initial visit (day 1)

• Second Evaluation of Specified Symptom Sum Score (SRRC)

  System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed during therapy.

  Change of SSRC at day 15 from initial visit

• Third Evaluation of Specified Symptom Sum Score (SRRC)

  System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed during therapy.

  Change of SSRC at day 29 from initial visit

• Fourth Evaluation of Specified Symptom Sum Score (SRRC)

  System with grading of scaliness, roughness, redness, and cracks with score ranges from 0-12 because the redness and cracks scores were limited to 2. Performed after 1 week of therapy discontinuation

  Change of SSRC at day 36

• First Evaluation of Skin Capacitance (SCap)

  Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed before therapy.

  Performed at initial visit (day-1)

• Second Evaluation of Skin Capacitance (SCap)

  Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed during therapy.

  Change of SCap at day-15

• Third Evaluation of Skin Capacitance (SCap)

  Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed during therapy.

  Change of SCap at day-29

• Fourth Evaluation of Skin Capacitance (SCap)

  Assess the skin barrier homeostasis condition using Corneometer® CM 825 (Courage - Khazaka, Germany). Performed after 1 week of therapy discontinuation

  Change of SCap at day-36

• First Evaluation of Transepidermal Water Loss (TEWL)

  Assess the skin barrier homeostasis condition using Tewameter® TM300 before therapy.

  Performed at initial visit (day-1)

• Second Evaluation of Transepidermal Water Loss (TEWL)

  Assess the skin barrier homeostasis condition using Tewameter® TM300. Performed during therapy.

  Change of TEWL at day-15 from initial visit

• Third Evaluation of Transepidermal Water Loss (TEWL)

  Assess the skin barrier homeostasis condition using Tewameter® TM300. Performed during therapy.

  Change of TEWL at day-29 from initial visit

• Fourth Evaluation of Transepidermal Water Loss (TEWL)

  Assess the skin barrier homeostasis condition using Tewameter® TM300. Performed after 1 week of therapy discontinuation.

  Change of TEWL at day-36 from initial visit

• First Side Effect Evaluation

  Subjective by the presence of contact dermatitis, folliculitis, and miliaria; objective by complaints of pruritus, sore, or stinging.

  Performed at 2 weeks after therapy (day-15)

• Second Side Effect Evaluation

  Subjective by the presence of contact dermatitis, folliculitis, and miliaria; objective by complaints of pruritus, sore, or stinging.

  Performed at day-29 (4 weeks after therapy)

• Third Side Effect Evaluation

  Subjective by the presence of contact dermatitis, folliculitis, and miliaria; objective by complaints of pruritus, sore, or stinging. Performed after 1 week of therapy discontinuation

  Performed at day-36 (5 weeks after therapy)

Study Arms (2)

12% AMMONIUM LACTATE

EXPERIMENTAL

Matching paired subject was conducted on 40 residents. Test subject received two different randomized moisturizing creams to be applied on two separate locations on the lower limbs twice a day for 4 weeks. One of the moisturising cream contained active ingredient 12% ammonium lactate. The evaluation of specified symptom sum score (SRRC), skin capacitance (SCap), transepidermal water loss (TEWL), and side effects were measured at baseline, week-2 and week-4 after therapy, and week-5 one week after therapy cessation.

Drug: Ammonium Lactate

10% UREA

ACTIVE COMPARATOR

Matching paired subject was conducted on 40 residents. Test subject received two different randomized moisturizing creams to be applied on two separate locations on the lower limbs twice a day for 4 weeks. One of the moisturising cream contained active ingredient 10% urea. The evaluation of specified symptom sum score (SRRC), skin capacitance (SCap), transepidermal water loss (TEWL), and side effects were measured at baseline, week-2 and week-4 after therapy, and week-5 one week after therapy cessation.

Drug: Urea

Interventions

Ammonium Lactate DRUG

12% ammonium lactate moisturizing cream

12% AMMONIUM LACTATE

Urea DRUG

10% urea moisturizing cream

10% UREA

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presenting with clinical diagnosis of xerosis cutis or with using the specified symptom sum score (SRRC)
• able to communicate well and perform daily activities independently
• willing to follow the research and sign the informed consent

You may not qualify if:

• sensitive to the ingredients in the formulations
• suffer from dermatitis or skin inflammation at the test site
• erythema and fissure values based on SRRC value \>2

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Faculty of Medicine University of Indonesia

Jakarta Pusat, DKI Jakarta, 10340, Indonesia

Location

MeSH Terms

Interventions

Lactic Acid; Urea

Intervention Hierarchy (Ancestors)

Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals; Amides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: same vehicle base ingredients, colour, smell, and packaging
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 15, 2019
• Study Start: April 1, 2017
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: October 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)