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

A Study of the Safety, Tolerability and Preliminary Efficacy of DRM01B Topical Gel in Healthy Volunteers and Subjects With Acne Vulgaris

This is a Phase 1/2a study.

The purpose of Phase 1 was to evaluate the safety and tolerability of DRM01B Topical Gel in 6 healthy volunteers.

The purpose of Phase 2a was to assess the safety, tolerability and preliminary efficacy of DRM01B Topical Gel compared to vehicle in subjects with acne vulgaris on the face.

Phase 1 Inclusion Criteria

1. Signed informed consent
2. Willing to comply with the requirements of the protocol
3. Males or non-pregnant, non-lactating females
4. Age ≥ 18 years
5. Was in good health and free from any clinically significant disease, as determined by the investigator
6. If female and of childbearing potential, was willing to use an accepted method of birth control during study participation and for 30 days after the last application of study drug. Females were considered to be of childbearing potential unless they had been surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation), had been diagnosed as infertile, had a same-sex partner or vasectomized male partner, were postmenopausal for at least 1 year, or were abstinent. Acceptable methods of birth control were defined as: abstinence, oral contraceptives, contraceptive patches/implants; Depo-Provera®, double barrier methods (e.g., condom and spermicide) or an intrauterine device (IUD). The birth control method must have been stable/unchanged for 30 days prior to baseline.
7. If male, was vasectomized or agreed to use an accepted method of birth control with female partner during study participation and for 30 days after the last application of study drug.

Phase 1 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.

Phase 2a Inclusion Criteria

1. Signed informed consent

2. Willing to comply with the requirements of the protocol

3. Male or non-pregnant, non-lactating females

4. Age ≥ 18 years

5. If female and of childbearing potential, was willing to use an accepted method of birth control during study participation and for 30 days after the last study drug application. Females were considered to be of childbearing potential unless surgically sterilized (hysterectomy, bilateral oophorectomy, tubal ligation), had been diagnosed as infertile, had same sex partner or vasectomized male partner, or were postmenopausal for at least 1 year. Acceptable methods of birth control were defined as: abstinence, oral contraceptives, contraceptive patches/implants; Depo-Provera®, double barrier methods (e.g., condom and spermicide) or an IUD. The birth control method must have been stable/unchanged for 12 weeks prior to baseline and must have remained unchanged during study participation.

6. If male, was vasectomized or agreed to use an accepted method of birth control with female partner during study participation and for 30 days after the last study drug application.

7. Subjects were in good health and free from any disease that, in the opinion of the investigator, would have put the subject at risk during participation in the study.

8. Clinical diagnosis of facial acne vulgaris defined as:

   • At least 20 inflammatory lesions
   • At least 20 noninflammatory lesions
   • IGA of 3 or greater

9. Willing to refrain from using any treatments, other than the investigational product, including antibiotics, for acne present on the face. Topical acne treatments that did not have significant or measurable systemic absorption (e.g., benzoyl peroxide, salicylic acid) were allowed for treatment of acne of the back, shoulders, and chest only.

Phase 2a Exclusion Criteria

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