Cutaneous MastocytosesPhase 2NCT04846348
Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis
A Phase 2 study testing Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base. in people with Cutaneous Mastocytoses, run by Joseph Butterfield at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness and tolerability of a novel topical preparation for the treatment of cutaneous lesions of mastocytosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cutaneous Mastocytoses
- What is being tested?
- Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2021to 10 Sep 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven cutaneous mastocytosis with or without evidence of systemic disease
- Male and female patients 18 to 80 years of age
- No UVB treatment of the skin for 6 months prior to study entry
- No use of topical or systemic corticosteroids for 1 month prior to study entry
- Good general health as confirmed by medical history
- Female patients of child-bearing potential with negative urine pregnancy test who agree to use effective methods of birth control or remain abstinent during treatment. Participants must use birth control for the entire study and for at least 1 week after the last application of the study formulation. Acceptable methods of birth control include ongoing hormonal contraception methods, (such as birth control pills, patches, injections, vaginal ring, or implants), barrier methods (such as a condom (for men) or diaphragm used with a spermicide), intrauterine devices, tubal ligation, or abstinence.
- Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
- Patients who read and sign an approved informed consent for this study
Who cannot join
- Vulnerable study population
- Exposure to ultraviolet B (UVB) radiation to any region of the skin surface for 6 months
- Regular use of skin lightening agents within 1 month of study entry, including
- Topical corticosteroids
- Topical bleaching products
- Topical retinoids
Show all 16Show fewer
- Use of systemic preparations within 1 month of study entry, including:
- Systemic corticosteroids
- Systemic cyclosporine, interferon
- Systemic acitretin, etretinate, isotretinoin
- Systemic methotrexate,
- Systemic photoallergic, phototoxic and/or photosensitizing drugs
- UV light therapy and sunbathing
- Inability to communicate or cooperate with the Principal Investigator and/or Investigators due to language problems, poor mental development or impaired cerebral function
- Pregnant or nursing women
- Women planning a pregnancy within the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: An Open-Label Pilot Study to Evaluate the Effectiveness and Tolerability of a Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis
The purpose of this study is to determine the effectiveness and tolerability of a novel topical preparation for the treatment of cutaneous lesions of mastocytosis.
- Conditions
- Cutaneous Mastocytoses
- Being tested
- Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base.
- Medical subject headings
- Mastocytosis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base.Combination product
Also called Skin Guard
Combination of ingredients includes 2 agents which target mast cell mediators and one agent which globally reduces mast cell degranulation combined in an emollient cream base (Vanicream).components: Vanicream: Over the counter emollient cream Diphenhydramine Antihistamine Trolamine salicylate Prostaglandin inhibitor, antiinflammatory Cromolyn Sodium Mast cell degranulation inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Skin Guard | Experimental | Skin cream combination of ingredients includes 2 agents which target mast cell mediators and one agent which globally reduces mast cell degranulation combined in an emollient cream base:
Vanicream: Over the counter emollient cream Diphenhydramine Antihistamine Trolamine salicylate Prostaglandin inhibitor, antiinflammatory Cromolyn Sodium Mast cell degranulation inhibitor Receives: Combination Product: Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous Symptom Relief
Number of participants who achieve complete resolution or near-complete clearing of cutaneous symptoms of treated, involved skin
Measured: 2 weeks
SkinDex-16 Quality of Life Questionnaire
This validated questionnaire is a 16-item, participant-reported survey used to assess quality of life impacts due to the participant's skin condition. Scores range from 0 to 6, where 0 is never bothered by the skin condition and 6 is always bothered by the skin condition. Results are summed to produce an overall score, ranging from 0 to 96, where lower scores indicated a higher level of quality of life.
Measured: Baseline
SkinDex-16 Quality of Life Questionnaire
This validated questionnaire is a 16-item, participant-reported survey used to assess quality of life impacts due to the participant's skin condition. Scores range from 0 to 6, where 0 is never bothered by the skin condition and 6 is always bothered by the skin condition. Results are summed to produce an overall score, ranging from 0 to 96, where lower scores indicated a higher level of quality of life.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start26 Jul 2021
- Primary completion10 Sep 2021
- Study completion10 Sep 2021
Why it stopped: It was difficult to enroll patients during the pandemic. A new oral drug, Avapritinib, has since been approved for systemic mastocytosis. This medication controls skin manifestations of mastocytosis and is more convenient for patients to use.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cutaneous MastocytosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph Butterfield
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph Butterfield, Mayo Clinic
- Investigators
- Joseph Butterfield, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846348
- Sponsor's protocol ID
- 20-011876
- Status last verified
- Mar 2024
- First submitted
- 12 Apr 2021
- Last updated
- 25 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study to Evaluate the Effectiveness and Tolerability of a Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis
- ClinicalTrials.gov ID
- NCT04846348
- Acronym / sponsor ID
- 20-011876
- Conditions
- Cutaneous Mastocytoses
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was difficult to enroll patients during the pandemic. A new oral drug, Avapritinib, has since been approved for systemic mastocytosis. This medication controls skin manifestations of mastocytosis and is more convenient for patients to use.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Joseph ButterfieldUniversity, hospital or other
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Posted 25 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness and tolerability of a novel topical preparation for the treatment of cutaneous lesions of mastocytosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin Guard | Experimental | Combination Product: Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base.Skin cream combination of ingredients includes 2 agents which target mast cell mediators and one agent which globally reduces mast cell degranulation combined in an emollient cream base: Vanicream: Over the counter emollient cream Diphenhydramine Antihistamine Trolamine salicylate Prostaglandin inhibitor, antiinflammatory Cromolyn Sodium Mast cell degranulation inhibitor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Biopsy proven cutaneous mastocytosis with or without evidence of systemic disease
- Male and female patients 18 to 80 years of age
- No UVB treatment of the skin for 6 months prior to study entry
- No use of topical or systemic corticosteroids for 1 month prior to study entry
- Good general health as confirmed by medical history
Key exclusion criteria (16 listed)
- Vulnerable study population
- Exposure to ultraviolet B (UVB) radiation to any region of the skin surface for 6 months
- Regular use of skin lightening agents within 1 month of study entry, including
- Use of systemic preparations within 1 month of study entry, including:
- UV light therapy and sunbathing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base.Also: Skin GuardCombination of ingredients includes 2 agents which target mast cell mediators and one agent which globally reduces mast cell degranulation combined in an emollient cream base (Vanicream).components: Vanicream: Over the counter emollient cream Diphenhydramine Antihistamine Trolamine salicylate Prostaglandin inhibitor, antiinflammatory Cromolyn Sodium Mast cell degranulation inhibitor | Combination product | Skin Guard |
Primary outcome
Cutaneous Symptom Relief
Time frame: 2 weeks
Number of participants who achieve complete resolution or near-complete clearing of cutaneous symptoms of treated, involved skin
SkinDex-16 Quality of Life Questionnaire
Time frame: Baseline
This validated questionnaire is a 16-item, participant-reported survey used to assess quality of life impacts due to the participant's skin condition. Scores range from 0 to 6, where 0 is never bothered by the skin condition and 6 is always bothered by the skin condition. Results are summed to produce an overall score, ranging from 0 to 96, where lower scores indicated a higher level of quality of life.
SkinDex-16 Quality of Life Questionnaire
Time frame: 2 weeks
This validated questionnaire is a 16-item, participant-reported survey used to assess quality of life impacts due to the participant's skin condition. Scores range from 0 to 6, where 0 is never bothered by the skin condition and 6 is always bothered by the skin condition. Results are summed to produce an overall score, ranging from 0 to 96, where lower scores indicated a higher level of quality of life.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Butterfield, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base. in people with Cutaneous Mastocytoses, run by Joseph Butterfield at 1 site in United States.
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 8 inclusion and 16 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: stopped early, as of the sponsor's last update on 25 Apr 2024. 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 United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cutaneous Symptom Relief (time frame: 2 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?
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 25 Apr 2024.