A Safety, Tolerability and Preliminary Efficacy Study of DRM01B Topical Gel

Exclusion Criteria

• •1. Females who were pregnant, planning to become pregnant during the course of the study, or were breast-feeding
• •2. Had a known hypersensitivity to DRM01B or its excipients
• •3. Had any skin condition that may have interfered with the safety evaluations during the study
• •4. Had a clinical chemistry or hematology laboratory value at screening that was considered clinically significant, in the opinion of the investigator
• •5. Participated in an investigational drug study within 30 days prior to screening
• •6. Were considered a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the investigator. Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
• •1. Females who were pregnant, planning to become pregnant during the course of the study, or breast-feeding
• •2. Had a known hypersensitivity to DRM01B or its excipients
• •3. Had any skin condition that may have interfered with evaluation of safety or acne vulgaris (e.g., rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or folliculitis)
• •4. Had excessive facial hair that would have interfered with diagnosis or assessment of acne vulgaris
• •5. Had excessive sun exposure, in the opinion of the investigator, or use of tanning booths
• •6. Had active cystic acne or acne conglobata, acne fulminans, and secondary acne
• •7. Had 2 or more active nodular lesions
• •8. Had a clinical chemistry or hematology laboratory value at screening that was considered clinically significant, in the opinion of the investigator
• •9. Participated in an investigational drug study within 30 days prior to screening
• •10. Subjects who were a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the investigator
• •11. Any other condition that, in the judgment of the investigator, would have put the subject at unacceptable risk during participation in the study
• •12. Treatment with over-the-counter (OTC) topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face within 2 weeks prior to baseline
• •13. Treatment with systemic corticosteroids within 4 weeks prior to baseline (Note: use of intranasal and inhaled corticosteroids was allowed for seasonal allergies and asthma)
• •14. Treatment with systemic antibiotics, systemic anti-acne drugs, or systemic anti-inflammatory drugs within 4 weeks prior to baseline
• •15. Prescription topical retinoid use on the face within 4 weeks of baseline (e.g., tretinoin, tazarotene, adapalene).
• •16. Treatment with a new hormonal therapy or dose change to an existing hormonal therapy within 12 weeks prior to baseline. The dose and frequency of use of any hormonal therapy started more than 12 weeks prior to baseline must have remained unchanged throughout the study. Hormonal therapies included, but were not limited to, estrogenic and progestational agents, such as birth control pills.
• •17. Prior use of androgen receptor blockers (such as spironolactone or flutamide)
• •18. Oral retinoid use (e.g., isotretinoin) within 12 months prior to baseline or vitamin A supplements greater than 10,000 units/day within 6 months of baseline
• •19. Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks or during the study