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Recruiting Phase 4 NCT07544251

Comparing Sarecycline and Doxycycline Effects on the Skin and Gut Bacteria in Acne.

Phase 4 – monitoring after market approval
Conditions: Acne Vulgaris

Sponsor: Integrative Skin Science and Research

trial.available_in: БГ
Overview
This study is being done to help better understand how the gut and skin bacteria of the body change when people with acne are treated with Sarecycline or Doxycycline. The bacteria in the gut and on the skin will be studied to see how each treatment may affect them and whether they change the profile of the bacteria that is present.
Who can participate
Inclusion Criteria: 1\) Diagnosis of acne vulgaris with: * At least 10 inflammatory lesions (papules, pustules, and nodules) up to 100 noninflammatory lesions (open and closed comedones) * No more than 2 nodules on the face Exclusion Criteria: 1. Dermatological condition of face or facial hair that could interfere with clinical evaluations 2. Subjects who have used the following medications (topical refers only to the facial area) will not be eligible: 2a) Within 2 week prior to randomization: * Topical acne medications such as retinoids, antibiotics, hormonal modulators * Topical benzoyl peroxide * Topical anti-inflammatories and corticosteroids 2b) Within 4 weeks prior to randomization: * Systemic antibiotics * Systemic acne treatments * Oral probiotic supplement * Systemic corticosteroids 2c) Within 12 weeks prior to randomization: * Systemic retinoids 3\) Individuals who have changed any of their hormonal based contraception or therapies within 3 months prior to joining the study. 4\) Individuals who are pregnant or breastfeeding. 5\) Individuals on oral contraceptive pills or progesterone or estrogen containing therapies unless they have been on a stable dose for 2 months. 6\) Individuals on finasteride or dutasteride 7\) Current tobacco smoker or a tobacco smoking history that is greater than 5 pack-years.
Interventions
Sarecycline
DRUG
Doxycycline
DRUG
Locations 1
United States (1)
Integrative Research Institute
Sacramento , California
Nasima Afzal Chief Operating Officer
Technical details
Status
Recruiting
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
9 Years
Healthy volunteers
No
Start date
20.04.2026
Completion date
01.06.2027
Registry ID
NCT07544251
Source
clinicaltrials.gov
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