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Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline (GINA3)

S

State University of New York - Downstate Medical Center

Status and phase

Unknown
Phase 2

Conditions

Asthma
Allergic Rhinitis

Treatments

Drug: Placebos
Drug: Minocycline Topical

Study type

Interventional

Funder types

Other

Identifiers

NCT04202263
1476585

Details and patient eligibility

About

Adults with known respiratory allergy/asthma with known skin test sensitization will undergo repeat skin prick testing at 4 areas of both arms (bilateral forearms, bilateral upper arms). Each site will be challenged with up to three known allergens, saline and histamine controls. Mean wheal diameter after 20 minutes challenge will be determined. This is followed by placement of minocycline cream (0%, 1%, 2%, 3%), placed in randomized fashion at each of 1 of 4 skin test sites. Measurement of subsequent wheal diameter will be done at 30 minutes, 60 minutes and 24 hours.

Full description

Adults with known respiratory allergy/asthma with known skin test sensitization will undergo repeat skin prick testing at 4 areas of both arms (bilateral forearms, bilateral upper arms). Each site will be challenged with up to three known allergens, saline and histamine controls. Mean wheal diameter after 20 minutes challenge will be determined. This is followed by placement of minocycline cream (0%, 1%, 2%, 3%), placed in randomized fashion at each of 1 of 4 skin test sites. Measurement of subsequent wheal diameter will be done at 30 minutes, 60 minutes and 24 hours.

In addition, itch assessment at each site will be done at baseline, 30 minutes, 60 minutes and 24 hours using VAS and questionnaire.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult ( ages 18-75) outpatients with diagnosis of allergic rhinoconjunctivitis and/or asthma who have previously undergone epicutaneous skin prick testing with detection of at least one allergen positive.

Exclusion criteria

  • Subjects who are unable/unwilling to undergo cessation of oral antihistamines for five days prior to testing.
  • Current use of oral steroids or other systemic immunosuppressants, including omalizumab (anti-IgE therapy) and anti-IL-5 therapy.
  • Allergic asthmatics who have current uncontrolled asthma.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

25 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo cream without minocycline
Treatment:
Drug: Placebos
Minocycline Arm
Active Comparator group
Description:
Minocycline cream (1%,2%,3%)
Treatment:
Drug: Minocycline Topical

Trial contacts and locations

1

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Central trial contact

Rauno O Joks; Catherine Calacanis

Data sourced from clinicaltrials.gov

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