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Atopic DermatitisPhase 1NCT02241174

0.005% Sodium Hypochlorite Final Rinse Solution in Atopic Dermatitis

A Phase 1 study testing Sodium Hypochlorite in people with Atopic Dermatitis, run by Makati Medical Center at 1 site in Philippines.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will determine the safety and efficacy of diluted bleach bath solution as final rinse on the reduction of Staphylococcus aureus colonization among children and adult Filipinos with mild to moderate atopic dermatitis.. Read more about this study

Who is it for?
Ages 8 years and olderHealthy volunteers can take part
Conditions the study is for
Atopic Dermatitis
What is being tested?
Sodium Hypochlorite
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 sitePhilippines
Study dates
Jul 2014to Feb 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Males and females more than 8 years old.
  • Subjects with clinical diagnosis of atopic dermatitis (based on Hannifin and Rajka criteria).
  • Healthy subjects with no other skin disease.
  • Subjects without any prior topical or oral antibiotic two weeks prior to the enrollment period. Those who had undergone course of topical and oral antibiotic are given at least 2 weeks washout period.

Who cannot join

  • Severe Atopic dermatitis requiring hospitalization.
  • Hospitalized and debilitated patients.
  • Subjects with other serious skin disorder, pigmentation or extensive scarring in affected areas.
  • Subjects who have a known history or clinically relevant allergy, in particular to chlorine containing compounds.
  • Pregnant women and nursing mothers.
  • Subjects who are in a situation, which, in the opinion of the investigator, may interfere with optimal participation in the study.
Show all 9Show fewer
  • Subjects participating or having participated in a clinical trial within 1 month before enrollment in the study.
  • Subjects who cannot communicate with the investigator (>18 years old) or are unaccompanied by parent or legal guardian (<18 years old).
  • Subjects who are unable to follow-up.

Trial locations and contacts

1 site in 1 country.

Philippines1 site

  • Makati Medical Center

    Makati, NCR, 1229

Other trials in Philippines

About this study

Official title: Efficacy of 0.005% Sodium Hypochlorite Final Rinse Solution on the Reduction of Staphylococcus Aureus Colonization in Atopic Dermatitis: A Randomized Controlled Trial

This study will determine the safety and efficacy of diluted bleach bath solution as final rinse on the reduction of Staphylococcus aureus colonization among children and adult Filipinos with mild to moderate atopic dermatitis..

Read the detailed description

Objective: To determine the safety and efficacy of 0.005% sodium hypochlorite final rinse solution on the reduction of Staphylococcus aureus colonization among children and adult Filipinos with mild to moderate atopic dermatitis.

Design: Randomized, double blind, controlled clinical trial. Setting: Makati Medical Center, Dermatology Outpatient Department Participants: Patients with mild to moderate atopic dermatitis, seen at Makati Medical Center Dermatology Outpatient Department.

Sample size: 68 (34 treatment group, 34 placebo group) Intervention: Eligible patients will be randomly allocated to two groups. The subjects will either be in the treatment group (0.005% sodium hypochlorite) or in the placebo group (bath water). Subjects will use a liter of 0.005% sodium hypochlorite as a final rinse solution during bathing for the treatment group and a liter of bath water for the placebo group. This intervention will be done twice a week for 12 weeks. Both patients and assessors will be blinded to the treatment assignments.

Assessment of Outcome: The outcomes will be assessed at weeks 4 and 12. Primary outcome measure will use culture findings, physician's global assessment (PGA) of severity of disease and eczema area and severity index (EASI) score. Secondary outcome measure will assess adverse effects during follow-up at weeks 4 and 12.

Data Analysis: Kruskal-Wallis Test will be used to compare the significant difference in scores between the two groups and Wilcoxon Signed Rank Test will be used to compare significant difference of before and after scores within each group.

Being tested
Sodium Hypochlorite
Keywords
Atopic Dermatitis
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium HypochloriteDrug

    The 0.005% sodium hypochlorite solutions will be prepared from the commercially available Clorox® at 6% solution. 0.83ml of the 6% sodium hypochlorite solution will be taken and incorporated to a-100ml absolute distilled water. This 100ml solution will be stored in an amber glass bottle at room temperature unexposed to light at a maximum of 23 months

Study groups in NCT02241174
Study groupRoleWhat they receive
Sodium HypochloriteExperimentalThe 0.005% sodium hypochlorite solutions will be prepared from the commercially available Clorox® at 6% solution. 0.83ml of the 6% sodium hypochlorite solution will be taken and incorporated to a-100ml absolute distilled water.
Receives: Drug: Sodium Hypochlorite
PlaceboPlacebo comparator100ml distilled water will be used as a placebo and will be stored on amber bottles identical with the treatment group
Receives: Drug: Sodium Hypochlorite

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Culture and sensitivity findings

    The primary outcome of interest is the reduction of S. aureus colonization in skin lesion and the clinical improvement at week 4 and week 12.

    Measured: 12 weeks

  2. Eczema Assessment Severity Index (EASI)

    Clinical decrease in the disease severity of atopic dermatitis Eczema Assessment Severity Index (EASI) b. Clinical decrease in the disease severity of atopic dermatitis Eczema Assessment Severity Index (EASI)

    Body regions to be assessed:

    1. Head/Neck
    2. Upper extremities
    3. Trunk
    4. Lower extremities

    In each of the body areas, the following key signs will be assessed:

    1. Erythema (E)
    2. Induration (I)
    3. Excoriation (Ex)
    4. Lichenification (L)

    Scoring from the above features:

    1. 0 - none
    2. 1 - mild
    3. 2 - moderate
    4. 3 - severe

    Body Surface Area involvement score:

    1. 0 = no eruption
    2. 1 = <10%
    3. 2 = 10%-29%
    4. 3 = 30% - 49%
    5. 4 = 50% - 69%
    6. 5 = 70% - 89%
    7. 6 = 90% - 100%

    EASI Score Body region EASI Score Head/neck (E + I + Ex + L) x Area x 0.1 Upper extremities (E + I + Ex + L) x Area x 0.2 Trunk (E + I + Ex + L) x Area x 0.3 Lower extremities (E + I + Ex + L) x Area x 0.4 EASI Sum of above scores

    Measured: 12 weeks

  3. Physician Global Assessment (PGA) Scale

    Severity of disease at baseline

    Mild:

    Moderate:

    Severe:

    Rating scale for PGA of Clinical Response at the end of the treatment

    Rating % Improvement Week 4 Week 12

    Cleared 100%

    Excellent improvement 90-99%

    Marked improvement 75-89%

    Moderate improvement 50-74%

    Slight improvement 30-49% No appreciable improvement 0-29%

    Measured: 12 weeks

Secondary outcomes (1)

  1. Adverse Effect

    An adverse effect is an adverse event for which the causal relation between the intervention and the event is at least a reasonable possibility. The term 'adverse effect' applies to all interventions, while 'adverse drug reaction' (ADR) is used only with drugs. Both will be measured in the study. All subjects will be asked if they have experienced any untoward effects from the intervention. In the event that any adverse events and adverse effects will be noted, immediate medical attention will be given to the participant(s) and the expenses of which, will be shouldered by the investigators.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionDec 2014 (estimated)
  4. Study completionFeb 2015 (estimated)

Why it stopped: study materials have expired, no patients were enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02241174
Sponsor's protocol ID
SodiumHypochloriteAD
Status last verified
Oct 2015
First submitted
12 Sep 2014
Last updated
20 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sodium Hypochlorite in people with Atopic Dermatitis, run by Makati Medical Center at 1 site in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Culture and sensitivity findings (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02241174.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.

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