Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris

Inclusion Criteria:

1. Male or non-pregnant, non-lactating female aged ≥ 12 and ≤ 40 years with a clinicaldiagnosis of acne vulgaris.

2. Subjects who are 18 years of age or older (up to the age of 40) must have providedIRB/IEC approved written informed consent. Subjects 12 to 17 years of age inclusivemust have provided IRB/IEC approved written assent; this written assent must beaccompanied by an IRB/IEC approved written informed consent from the Subject'slegally acceptable representative (i.e., parent or guardian). In addition, allSubjects or their legally acceptable representatives (i.e., parent or guardian) mustsign a HIPAA authorization.

3. Subjects must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones)AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocysticlesions (i.e.,nodules and cysts), at screening/baseline on the face.

(a) For the purposes of study treatment and evaluation, these lesions should belimited to the facial treatment area. All lesions will be counted, including thosepresent on the nose. Subjects may have acne lesions on other areas of the body whichwill be excluded from the count and the Investigator's Global Assessment (IGA)evaluation (e.g., on the back, chest and arms).

4. Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below) atscreening/baseline. Acne vulgaris should be stable (for at least 3 months prior toscreening), with minimal variation from day to day and within each day, in theopinion of the subject. Table 1: Investigator's Global Assessment (IGA) Scale for Acne Vulgaris GradeDescription 0 Clear skin with no inflammatory or non-inflammatory lesions 1 Almostclear; rare non-inflammatory lesions with no more than one small inflammatory lesion 2 Mild severity; greater than Grade 1; some non-inflammatory lesions with no morethan a few inflammatory lesions (papules/pustules only, no nodular lesions) 3Moderate severity; greater than Grade 2; up to many noninflammatory lesions and mayhave some inflammatory lesions, but no more than one small nodular lesion 4* Severe;greater than Grade 3; up to many non-inflammatory lesions and may have someinflammatory lesions, but no more than a few nodular lesions

• The eCRF will allow for reporting by Investigators of lesion worsening beyondGrade 4 with treatment. Acne vulgaris subjects with nodulocystic acne are not to beenrolled in the study. Subjects who worsen beyond Grade 4 will be described in the safety evaluation. Note:Counts of nodules and cysts will be reported separately and not included in theinflammatory or non-inflammatory lesion counts.

5. Subjects must be willing to refrain from using all other topical acne medications orantibiotics during the 12-week treatment period, other than the investigationalproduct.

6. Female subjects of childbearing potential (*WOCBP) must not be pregnant or lactatingat the time of screening/baseline visit as documented by a negative urine pregnancytest with a sensitivity to at least 25 mIU/ml hCG .

*Female subjects of childbearing potential (WOCBP) are defined as sexually maturewomen without prior hysterectomy, or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for the past 12 or more months are stillconsidered to be of childbearing potential, if the amenorrhea is possibly due toother causes, including prior chemotherapy, anti- estrogens, or ovarian suppression.Postmenopausal women (defined as women who have been amenorrheic for at least 12consecutive months, in the appropriate age group, without other known or suspectedprimary cause) or women who have been sterilized surgically or who are otherwiseproven sterile (i.e., total hysterectomy, or bilateral oophorectomy with surgery atleast 4 weeks prior to randomization) are not considered WOCBP. Subjects who haveundergone tubal ligation are NOT considered as surgically sterile.

7. Female subjects of childbearing potential must be willing to use an acceptable formof birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.

8. For the purposes of this study the following are considered acceptable methodsof birth control: oral or injectable contraceptives, contraceptive patches,medroxyprogesterone acetate (ex. Depo-Provera®) with stabilized use for atleast 3 months, vaginal contraceptive (ex. etonogestrel/ethinyl estradiolvaginal ring (ex. NuvaRing®), contraceptive implant with etonogestrel orequivalent, double barrier methods, (e.g.condom and spermicide), intrauterine device (IUD), true abstinence (if in linewith subject's lifestyle).

9. If a subject who was abstinent becomes sexually active during the study, a 2ndacceptable method of birth control should be used and documented.

10. Subjects on hormonal contraception must be stabilized on the same type for atleast three months prior to enrollment in the study and must not change themethod during the study. A sterile sexual partner is not considered an adequate form of birth control.

11. Female subjects who are premenarchal, surgically sterilized (by *hysterectomy orbilateral oophorectomy) or postmenopausal for at least 1 year (defined as women whohave been amenorrheic for at least 12 consecutive months, without other known orsuspected primary cause).

12. All male subjects must agree to use accepted methods of birth control with theirpartners, from the day of the first dose administration to 30 days after the lastadministration of study drug. True abstinence is an acceptable method of birth control if in line with subject'slifestyle. Female partners should use an acceptable method of birth control as described in theabove criteria 7.

13. Subjects must be willing and able to understand and comply with the requirements ofthe protocol, including attendance at all required study visits and refraining fromthe use of all other topical acne medications or antibiotics during the 12-weektreatment period.

14. Subjects must be in good health and free from any clinically significant disease,which may interfere with the evaluation of acne vulgaris or the administration ofthe investigative product.

15. Subjects who use make-up must have used the same brands/types of make-up for aminimum period of 14 days prior to study entry and must agree to not change make-upbrand/type or frequency of use throughout the study.

Exclusion Criteria:

1. Female subjects who are pregnant, lactating or planning to become pregnant duringstudy participation.

2. Subjects with a history of hypersensitivity or allergy to trifarotene, tretinoin,retinoids, or any of the study medication ingredients.

3. Subjects with the presence of any skin condition that would interfere with thediagnosis or assessment of acne vulgaris (such conditions include but are notlimited to the following on the face: rosacea, dermatitis, psoriasis, squamous cellcarcinoma, eczema, acneiform eruptions caused by medications, steroid orcorticosteroid-induced acne, steroid folliculitis, or bacterial folliculitis,auto-immune disease, perioral dermatitis, carcinoid syndrome, mastocytosis,acneiform eruptions caused by make-up and medication, facial psoriasis and facialeczema).

4. Subjects with nodulocystic acne (> 2 nodules and cysts). [Nodules or cysts definedas; deepseated in the skin (i.e., centered in the dermis or subcutis) and aninflammatory lesion greater than or equal to 5 mm in diameter], acne conglobata,acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) or acne vulgarisrequiring systemic treatment.

5. Subjects with excessive facial hair (e.g., beards, sideburns, moustaches, etc.) thatwould interfere with diagnosis or assessment of acne vulgaris.

6. Subjects with tattoos or excessive facial scarring that, in the Investigator'sopinion, may interfere with the evaluation of the patient's acne.

7. Subjects who have used within 6 months prior to screening/baseline oral retinoids (e.g., Accutane®) or therapeutic vitamin A supplements of greater than 10,000units/day (multivitamins are allowed). These treatments with oral retinoids orVitamin A supplements are prohibited during the study participation.

8. Subjects who have used within 1 month prior to screening/baseline neuromuscularblocking agents or androgen receptor blockers (e.g., spironolactone, Flutamideetc.).

9. Subjects who have had laser therapy, electrodessication phototherapy and or cosmeticprocedures (e.g., ClearLight ® BOTOX, Filler, micro needling) to the facial areawithin 6 months prior to study entry.

10. Subjects who have had facial cosmetic procedures (e.g., facials) or application ofcosmetic products (cosmetics, makeup or facial products that have a strong drying orpossible interactive effect, particularly preparations containing spices, limesulfur, resorcinol, or salicylic acid with tretinoin or other retinoids) which mayaffect the efficacy and safety profile of the investigational product within 2 weeksprior to study entry.

11. Subjects who have received radiation therapy and/or anti-neoplastic agents within 3months prior to screening/baseline.

12. Subjects who have used for less than (<) 3 months prior to screening/baselineestrogens or oral contraceptives; use of such therapy must remain constantthroughout the study.

13. Subjects who have used any of the following procedures on the face within 1 monthprior to screening/baseline or use during the study:

14. cryodestruction or chemodestruction,

15. dermabrasion,

16. photodynamic therapy,

17. acne surgery,

18. intralesional steroids, or

19. X-ray therapy.

20. Subjects who have used any of the following treatments within 1 month prior toscreening/baseline or during the study:

21. androgen receptor blockers (e.g., spironolactone, Flutamide etc.)

22. systemic steroids,

23. systemic antibiotics,

24. systemic treatment for acne vulgaris (other than oral retinoids, which requirea 6-month washout),

25. systemic anti-inflammatory agents. If Subject uses a systemic anti-inflammatoryproduct during the study, the Principal Investigator will judge if thisprotocol deviation is clinically significant,

26. have taken any drugs that lower the immune system.

27. topical immunomodulators

28. Subjects who have used any of the following treatments within 2 weeks prior toscreening/baseline or during the study:

29. topical steroids,

30. topical retinoids,

31. topical acne treatments including over-the-counter preparations

32. topical anti-inflammatory agents

33. topical antibiotics

34. abradants,

35. peels containing glycolic or other acids,

36. washes or soaps, containing glycolic acid,

37. Alpha-hydroxy acids,

38. sulfacetamide sodium,

39. non-mild facial cleansers, moisturizers that contained retinol

40. topical products that contain high amounts of alcohol

41. wax depilation of the face

42. Use of tanning booths

43. The application of alcohol-based toners or any product with high concentrationsof alcohol, astringents, medicated topical preparations (prescription and OTCproducts including those with spices or lime ingredients). or medicatedmake-up, medicated or harsh soaps, medicated cleansers, and cosmetics that makesubject skin dry to the face (products that have a strong drying effect,particularly preparations containing sulfur, resorcinol, or salicylic acid withtretinoin or other retinoids).

44. Subjects who have on-going malignancies requiring systemic treatment or who have anymalignancy of the skin of the facial area.

45. Subjects with active facial sunburn or peeling from sunburn.

46. Subjects who engage in activities that involve excessive or prolonged exposure tosunlight or weather extremes, such as wind or cold. Exposure to excessive UVradiation within 1 week prior to screening/baseline.

47. Subjects who use a sauna within 48 hours prior to screening/baseline.

48. Subjects who have unstable medical disorders that are clinically significant or havelife threatening diseases, or other medical condition (i.e., chronic infectiousdisease, system disorder, organ disorder, cardiovascular, gastrointestinal,hematological, hepatic, neurological, pancreatic, renal disease, severe psychiatriccondition, etc.) that, in the Investigator's opinion, would place the study Subjectat undue risk by participation or could jeopardize the integrity of the studyevaluations.

49. Subjects who consume excessive amounts of alcohol (greater than two drinks per day)or use drugs of abuse (including, but not limited to, cannabinoids, cocaine andbarbiturates) within one year prior to screening.

50. Subjects, who in the opinion of the Investigator, would be non-compliant with therequirements of the study protocol.

51. Subjects who are unable or unwilling to give informed consent.

52. Subjects who are illiterate.

53. Subjects who have participated in an investigational drug study (i.e., Subjects havebeen treated with an investigational drug) within 30 days prior toscreening/baseline or where sufficient washout period has not been achieved;whichever time period is longer. Subjects who are participating in non-treatmentstudies such as observational studies or registry studies can be considered forinclusion.

54. Subjects who have been previously enrolled in this study.

55. Subjects who live in the same household with subjects who are participating or havebeen previously enrolled in this study.

56. The subject is a member of the investigational study staff or a family member of theinvestigational study staff.

57. Subject having symptoms* of Coronavirus Disease 2019 (COVID-19) within the 10 daysprior to screening/baseline/visit 1 or have had close contact with someone withsuspected or confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)infection within 10 days prior to screening/baseline/visit 1 or who are at high riskof SARS-CoV-2 infection, defined as adults whose locations or circumstances put themat appreciable risk of acquiring SARS-CoV-2 infections.

• Stuffy or runny nose, sore throat, shortness of breath (difficulty breathing),cough, low energy or tiredness, muscle or body aches, headache, chills orshivering, feeling hot or feverish, vomiting, diarrhea, loss of sense of tasteand smell.