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

• Sponsor: Indonesia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04127513
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 2
• Patients Per Site Per Month: 20.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Xerosis Cutis	Drug: Ammonium Lactate; Drug: Urea	Phase 3

Detailed Description

Dry skin or xerosis cutis is widely known skin health issue in geriatric population with prevalence rate ranges between 29.5 - 85.5%. One of the internal etiological factors is decreased production of natural moisturizing factor as a humectant. Application of moisturizer is the mainstay treatment. Moisturizer with humectant property, like lactate and urea, could restore skin hydration and barrier dysfunction. This study aims to compare the efficacy and safety between moisturizing cream containing 12% ammonium lactate and 10% urea in geriatric with xerosis cutis.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: same vehicle base ingredients, colour, smell, and packaging
• Primary Purpose: Treatment
• Official Title: Comparison of Efficacy and Safety Between Moisturising Cream Containing 12% Ammonium Lactate AND 10% Urea in Geriatric With Xerosis Cutis: Double Blind Randomised Controlled Trial
• Actual Study Start Date: Apr 1, 2017
• Actual Primary Completion Date: May 31, 2017
• Actual Study Completion Date: May 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 12% AMMONIUM LACTATE 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; 12% ammonium lactate moisturizing cream
Active Comparator: 10% UREA 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; 10% urea moisturizing cream

Outcome Measures

Primary Outcome Measures

1. First Evaluation of Specified Symptom Sum Score (SRRC) [initial visit (day 1)]

   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.

2. Second Evaluation of Specified Symptom Sum Score (SRRC) [Change of SSRC at day 15 from initial visit]

   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.

3. Third Evaluation of Specified Symptom Sum Score (SRRC) [Change of SSRC at day 29 from initial visit]

   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.

4. Fourth Evaluation of Specified Symptom Sum Score (SRRC) [Change of SSRC at day 36]

   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

5. First Evaluation of Skin Capacitance (SCap) [Performed at initial visit (day-1)]

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

6. Second Evaluation of Skin Capacitance (SCap) [Change of SCap at day-15]

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

7. Third Evaluation of Skin Capacitance (SCap) [Change of SCap at day-29]

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

8. Fourth Evaluation of Skin Capacitance (SCap) [Change of SCap at day-36]

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

9. First Evaluation of Transepidermal Water Loss (TEWL) [Performed at initial visit (day-1)]

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

10. Second Evaluation of Transepidermal Water Loss (TEWL) [Change of TEWL at day-15 from initial visit]

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

11. Third Evaluation of Transepidermal Water Loss (TEWL) [Change of TEWL at day-29 from initial visit]

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

12. Fourth Evaluation of Transepidermal Water Loss (TEWL) [Change of TEWL at day-36 from initial visit]

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

13. First Side Effect Evaluation [Performed at 2 weeks after therapy (day-15)]

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

14. Second Side Effect Evaluation [Performed at day-29 (4 weeks after therapy)]

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

15. Third Side Effect Evaluation [Performed at day-36 (5 weeks after therapy)]

    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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine University of Indonesia	Jakarta Pusat	DKI Jakarta	Indonesia	10340

Sponsors and Collaborators

• Indonesia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eyleny Meisyah Fitri, Principal Investigator, Indonesia University
• ClinicalTrials.gov Identifier: NCT04127513
• Other Study ID Numbers: ThesisEyleny
• First Posted: Oct 15, 2019
• Last Update Posted: Oct 15, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eyleny Meisyah Fitri, Principal Investigator, Indonesia University: xerosis cutis; geriatric; 12% ammonium lactate; 10% urea

Study Results

No Results Posted as of Oct 15, 2019