Timolol for the Treatment of Acne and Rosacea
| Status: | Recruiting |
|---|---|
| Conditions: | Acne, Acne, Cosmetic, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/17/2019 |
| Start Date: | March 2016 |
| End Date: | March 2022 |
| Contact: | Bao Chau Ly |
| Email: | bly1@jhmi.edu |
| Phone: | 410-502-7546 |
This research is being done to determine the safety and tolerability of timolol in the
treatment of acne and rosacea. The investigators will also look for specific biomolecular
changes in acne or rosacea skin when it is exposed to timolol.
Timolol is approved by the Food and Drug Administration (FDA) for the treatment of glaucoma.
In dermatology, it has been used as a treatment to decrease the size of vascular (blood
vessel) malformations in infant skin. Timolol is not approved for use in acne or rosacea and
its use in this study is investigational.
Many people with rosacea have telangiectasias which are small, red dilated blood vessels on
the skin. They also suffer from flushing and acne-like lesions. Better treatments than those
currently available are desired.
Acne vulgaris, or acne, is another chronic inflammatory and very common skin disease that
affects about 8 out of 10 young adults and adolescents. Signs of acne include papules and
blackheads that are often called primary lesions because they represent an active form of the
disease. There are also secondary lesions that can form later; they are known as acne scars
treatment of acne and rosacea. The investigators will also look for specific biomolecular
changes in acne or rosacea skin when it is exposed to timolol.
Timolol is approved by the Food and Drug Administration (FDA) for the treatment of glaucoma.
In dermatology, it has been used as a treatment to decrease the size of vascular (blood
vessel) malformations in infant skin. Timolol is not approved for use in acne or rosacea and
its use in this study is investigational.
Many people with rosacea have telangiectasias which are small, red dilated blood vessels on
the skin. They also suffer from flushing and acne-like lesions. Better treatments than those
currently available are desired.
Acne vulgaris, or acne, is another chronic inflammatory and very common skin disease that
affects about 8 out of 10 young adults and adolescents. Signs of acne include papules and
blackheads that are often called primary lesions because they represent an active form of the
disease. There are also secondary lesions that can form later; they are known as acne scars
Rosacea affects roughly 16 million Americans who desire better treatments than those
currently available. Acne vulgaris, another chronic inflammatory skin disorder, mainly
affects teenagers but also affects 20-40% of adults. Investigating potential new treatments
will not only satisfy a clinical need, but also offers the opportunity to learn about the
pathogenesis of the disease and skin biology. The purpose of this study is to investigate the
possible role of timolol as a therapy for the erythema and papules associated with acne and
rosacea. It has been shown that timolol is beneficial and safe to treat infantile
hemangiomas. The investigators hypothesize that it may also be safe and effective in the
treatment of acne and rosacea.
In a single experiment where the test case was the PI (a practicing physician), the
investigators treated his rosacea with timolol for this off-label indication and have noticed
an improvement in flushing and an unexpected improvement in acneiform eruptions associated
with the rosacea. After 30 days, less flushing and acneiform lesions were noted on the
treated right side compared to the left side . Similarly, at 60 days after treatment, as
visualized by infrared imaging, significantly less inflammation and flushing was noted on the
treated right side even outside of episodes of flushing. The improvement was durable, such
that after a 60 day washout, improvements were still noted. In summary, during testing of the
PI as a case subject, timolol appeared effective, safe, and with some disease-remissive
effects.
Our aim is to conduct a 16 week split-face pilot study with up to 30 patients who have a
diagnosis of either inflammatory acne or rosacea to assess whether timolol maleate
effectively reduces erythema, flushing, telangiectasias, and/or papules. The investigators
also propose to biopsy a subset of our study patients to examine the biological activity in
the skin before and after treatment. The investigators are particularly interested in
studying epigenetic DNA methylation abnormalities in these conditions at baseline to compare
to normal subjects and as a result of therapy.
currently available. Acne vulgaris, another chronic inflammatory skin disorder, mainly
affects teenagers but also affects 20-40% of adults. Investigating potential new treatments
will not only satisfy a clinical need, but also offers the opportunity to learn about the
pathogenesis of the disease and skin biology. The purpose of this study is to investigate the
possible role of timolol as a therapy for the erythema and papules associated with acne and
rosacea. It has been shown that timolol is beneficial and safe to treat infantile
hemangiomas. The investigators hypothesize that it may also be safe and effective in the
treatment of acne and rosacea.
In a single experiment where the test case was the PI (a practicing physician), the
investigators treated his rosacea with timolol for this off-label indication and have noticed
an improvement in flushing and an unexpected improvement in acneiform eruptions associated
with the rosacea. After 30 days, less flushing and acneiform lesions were noted on the
treated right side compared to the left side . Similarly, at 60 days after treatment, as
visualized by infrared imaging, significantly less inflammation and flushing was noted on the
treated right side even outside of episodes of flushing. The improvement was durable, such
that after a 60 day washout, improvements were still noted. In summary, during testing of the
PI as a case subject, timolol appeared effective, safe, and with some disease-remissive
effects.
Our aim is to conduct a 16 week split-face pilot study with up to 30 patients who have a
diagnosis of either inflammatory acne or rosacea to assess whether timolol maleate
effectively reduces erythema, flushing, telangiectasias, and/or papules. The investigators
also propose to biopsy a subset of our study patients to examine the biological activity in
the skin before and after treatment. The investigators are particularly interested in
studying epigenetic DNA methylation abnormalities in these conditions at baseline to compare
to normal subjects and as a result of therapy.
Inclusion Criteria:
- In the opinion of the investigator, must be medically able to undergo the
administration of study material
- Be able to comprehend the informed consent document and provide consent for
participation
- Females of childbearing potential must:
- Not be pregnant by subjective report
- agree to not become pregnant or breastfeed for the period of the study through 1
month after completion of the study
- be willing to use a reliable form of contraception during the study
- Be willing and able to comply with the scheduled visits and other study procedures for
the duration of the study.
- Be willing not to take any other medicine for acne or rosacea during the study
- Acne specific inclusion criteria:
o 10-100 noninflammatory, 20-50 inflammatory lesions (nose excluded)
- Rosacea specific inclusion criteria:
- History of frequent flushing
- Skin erythema - Positive (not negative) chromometer minimum reading difference
when subtracting nonaffected reading from affected reading.
Goal would be greater than 1 unit difference between red areas. For example, the red area
(average 17.7 Chroma Meter a) and nonaffected areas (average 14.1 Chroma Meter a), yields
in an optimum scenario greater than 3 point difference in this example (in subjects with
average Chromometer L value averaging 56.6-59.6). Example from (Helfrich et al., 2015).
o Presence of inflammatory papules
Exclusion Criteria:
- Having received any investigational drug within 30 days prior to study entry
- An allergy history to any study materials including any beta-blockers.
- Pregnant, lactating, or trying to become pregnant
- Severe depression
- Hypotension or history
- Bradycardia or history
- History of Cardiac Heart Failure
- History of Myocardial infarction
- History of heart arrhythmia
- Asthma or Bronchospasm or history
- Rosacea specific exclusion criteria:
Recent topicals within 3 weeks Oral rosacea medications such as antibiotics within 3 weeks
• Acne specific exclusion criteria: nodular acne man with beard which interferes with
clinical evaluation history of Accutane Oral contraceptive pills changes last 3 months
Topical retinoid within 4 weeks Cosmetic procedures (like facial or peels) for 4 weeks
Photodynamic therapy , laser therapy or microdermabrasion for 4 weeks Other topicals or
oral acne medications such as antibiotics within 3 weeks
o Biopsy volunteer specific exclusion criteria: History of keloids History of hypertrophic
scars Allergy to lidocaine or epinephrine
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