Safety and Efficacy of ACU-D1 in the Treatment of Acne Rosacea
Condition: Acne Rosacea
MeSH terms: Rosacea
Intervention: ACCU-D1; Vehicle
Intervention description: ACCU-D1; Placebo Comparator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study evaluated the safety, tolerability, and efficacy of ACCU-D1 when applied twice
      daily for 12 weeks in adult participants with moderate to severe acne rosacea. Two-third of
      the participants received ACCU-D1 while one-third of the participants received vehicle
      control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is male or non-pregnant and non-lactating female at least 18 years of age

          -  Participant has a clinical diagnosis of stable papulopustular rosacea (type-2)

          -  Participant has a total of ≥10 and ≤40 inflammatory lesions (papules, pustules, and
             nodules) on the face

          -  Participant has ≤2 nodules on the face

          -  Participant has an investigator's global assessment (IGA) score of ≥3

          -  If the participant is a woman of childbearing potential, she has a negative urine
             pregnancy test and agrees to use an approved effective method of birth control for the
             duration of the study

          -  Participant is in good general health and free of any known disease state or physical
             condition which, in the investigator's opinion, might impair evaluation of rosacea or
             which exposes the participant to an unacceptable risk by study participation

          -  Participant is willing and able to follow all study instructions and to attend all
             study visits

          -  Participant is able to comprehend and willing to sign an informed consent form

        Exclusion Criteria:

          -  Participant is pregnant, nursing, or planning to become pregnant during the duration
             of the study

          -  Participant has used systemic glucocorticosteroids within 42 days prior to Visit 1
             (inhaled and ocular glucocorticosteroids are permitted)

          -  Participant has used systemic antibiotics within 28 days prior to Visit 1

          -  Participant has used any topical glucocorticosteroids on the face within 28 days prior
             to Visit 1

          -  Participant has used any prescription or over-the-counter product for the treatment of
             acne or rosacea within 14 days prior to Visit 1

          -  Participant is currently using any therapy that, in the investigator's opinion, is a
             photosensitizer (for example, phenothiazines, amiodarone, quinine, thiazides,
             sulphonamides, quinolones, etc.)

          -  Participant currently has any skin disease (for example, psoriasis, atopic dermatitis,
             eczema), or condition (for example, actinic keratosis, photo-damage, sunburn,
             excessive hair, open wounds) that, in the investigator's opinion, might impair
             evaluation of rosacea or which exposes the subject to an unacceptable risk by study
             participation

          -  Participant currently has, on the face, or has had on the face, any of the following
             within the specified period prior to Visit 1 that, in the investigator's opinion,
             might impair evaluation of rosacea or which exposes the subject to an unacceptable
             risk by study participation:

               -  A cutaneous malignancy; 180 days

               -  Experienced a sunburn; 14 days

          -  Participant has facial hair, that in the investigator's opinion, might impair
             evaluation of rosacea or proper study medication application

          -  Participant has a history of sensitivity to any of the ingredients in the study
             medications

          -  Participant has participated in an investigational drug trial in which administration
             of an investigational study medication occurred within 30 days prior to Visit 1