Bleach Bath Treatment of Adults With Atopic Dermatitis
| Status: | Completed |
|---|---|
| Conditions: | Psoriasis, Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/19/2018 |
| Start Date: | January 2014 |
| End Date: | June 1, 2017 |
Assessing the Impact of Bleach Baths on Itch, Cutaneous Inflammation, Microbial Flora and Skin Barrier Function in Adult Atopic Dermatitis Subjects
This is pilot, mechanistic study to address whether bleach baths given to adult subjects with
atopic dermatitis or eczema, who are colonized with the bacteria Staphylococcus aureus, will
significantly alter their skin microbiome and in so doing improve their skin barrier,
diminish expression of inflammatory proteins in the skin and improve itch. To answer these
questions the investigators will perform a 3-month, pilot, investigator-initiated,
single-center, open-label clinical study. This study will allow us to test the following
hypothesis: 1) that bleach baths will normalize skin barrier function, 2) that bleach baths
will diminish the local inflammatory response in the skin, and 3) that bleach baths will
improve validated measures of itch (also called pruritus).
atopic dermatitis or eczema, who are colonized with the bacteria Staphylococcus aureus, will
significantly alter their skin microbiome and in so doing improve their skin barrier,
diminish expression of inflammatory proteins in the skin and improve itch. To answer these
questions the investigators will perform a 3-month, pilot, investigator-initiated,
single-center, open-label clinical study. This study will allow us to test the following
hypothesis: 1) that bleach baths will normalize skin barrier function, 2) that bleach baths
will diminish the local inflammatory response in the skin, and 3) that bleach baths will
improve validated measures of itch (also called pruritus).
Atopic Dermatitis subjects have different proportions of bacterial communities on their skin
surface. Often, their skin is colonized with the pathogenic bacteria called Staphylococcus
aureus. Studies have demonstrated a remarkable clinical improvement in Atopic Dermatitis
subjects who take bleach baths two times per week for three months. The assumption was that
this worked by reducing the S. aureus on the skin surface but by standard culture techniques
there was no change in S. aureus colonization. Therefore, the mechanism by which these bleach
baths improved the disease remains entirely unknown. This study will assess the effects
bleach baths have on bacteria that can and cannot be cultured using new molecular biologic
tools that have shown us that the skin is home to thousands of different microbial species.
This bacterial ecosystem is called the microbiome. The investigators will also determine
whether bleach baths affect skin barrier integrity and the cutaneous expression of
lymphocyte-derived cytokines that are thought to cause the skin inflammation in subjects with
Atopic Dermatitis. The investigators will also assess to what degree these baths improve
disease severity and the symptoms of itch using validated scoring systems. This work will
likely uncover new ideas about the pathogenesis of Atopic Dermatitis and may be the first
step to developing new pro-microbial and antimicrobial therapeutics.
This study is designed to test the following hypotheses:
1. The chronic use of bleach baths will normalize skin barrier function in adult Atopic
Dermatitis subjects as measured by physiological measures of barrier in vivo, and as
assessed by ex vivo studies (measuring transepithelial electrical resistance (TEER) and
permeability of the epidermis from skin biopsies). The investigators will evaluate
whether any of the functional changes correlate with changes in expression of relevant
tight and intercellular junction molecules at the messenger ribonucleic acid (mRNA)
level.
2. Bleach baths will improve validated measures of pruritus (itch).
3. Bleach baths will diminish the local T-helper 2 (Th2) immune response measured from skin
biopsy samples.
surface. Often, their skin is colonized with the pathogenic bacteria called Staphylococcus
aureus. Studies have demonstrated a remarkable clinical improvement in Atopic Dermatitis
subjects who take bleach baths two times per week for three months. The assumption was that
this worked by reducing the S. aureus on the skin surface but by standard culture techniques
there was no change in S. aureus colonization. Therefore, the mechanism by which these bleach
baths improved the disease remains entirely unknown. This study will assess the effects
bleach baths have on bacteria that can and cannot be cultured using new molecular biologic
tools that have shown us that the skin is home to thousands of different microbial species.
This bacterial ecosystem is called the microbiome. The investigators will also determine
whether bleach baths affect skin barrier integrity and the cutaneous expression of
lymphocyte-derived cytokines that are thought to cause the skin inflammation in subjects with
Atopic Dermatitis. The investigators will also assess to what degree these baths improve
disease severity and the symptoms of itch using validated scoring systems. This work will
likely uncover new ideas about the pathogenesis of Atopic Dermatitis and may be the first
step to developing new pro-microbial and antimicrobial therapeutics.
This study is designed to test the following hypotheses:
1. The chronic use of bleach baths will normalize skin barrier function in adult Atopic
Dermatitis subjects as measured by physiological measures of barrier in vivo, and as
assessed by ex vivo studies (measuring transepithelial electrical resistance (TEER) and
permeability of the epidermis from skin biopsies). The investigators will evaluate
whether any of the functional changes correlate with changes in expression of relevant
tight and intercellular junction molecules at the messenger ribonucleic acid (mRNA)
level.
2. Bleach baths will improve validated measures of pruritus (itch).
3. Bleach baths will diminish the local T-helper 2 (Th2) immune response measured from skin
biopsy samples.
Inclusion Criteria:
- Moderate to severe Atopic dermatitis: Eczema Area and Severity Index (EASI) score ≥
10.
- Skin culture positive for Staphylococcus aureus
- Must have active skin disease on the day of enrollment.
Exclusion Criteria:
- Unwillingness or inability to complete informed consent
- Lidocaine or Novocain allergy
- History of keloid formation
- Course of systemic antibiotics or antivirals within 2 weeks prior to enrollment.
We found this trial at
1
site
601 Elmwood Avenue
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2100
Phone: 585-273-4195
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
Click here to add this to my saved trials
