A bioequivalence study of Tretinoin Gel microsphere 0.08 percent (Amneal pharmaceuticals LLC, USA) as compared to reference medicinal product, Retin-A Micro (Tretinoin) Gel Microsphere 0.08 percent (Valeant pharmaceuticals North America LLC) in patients with acne vulgaris
- Conditions
- Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
- Registration Number
- CTRI/2024/07/069994
- Lead Sponsor
- Amneal Pharmaceuticals LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Healthy males or non-pregnant, non-lactating females aged = 12 and = 40 years with a clinical diagnosis of acne vulgaris.
2.Subjects aged 18 years or older (up to the age of 40 years) must have provided IRB/IEC approved written informed consent. Subjects aged 12 to 17 years inclusive, must provide IRB/IEC approved written assent; this written assent must be accompanied by an IRB/IEC approved written informed consent from the subject’s legally acceptable representative (i.e., parent or guardian).
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 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face.
Note: For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. All facial lesions will be counted, including those on the nose.1 Counts of nodules and cysts will be reported separately and not included in the inflammatory or non-inflammatory lesion counts. Nodulocystic lesions will not be included in the inflammatory lesion count
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)
5.Subjects must be willing to refrain from using all other topical acne medications or antibiotics for acne vulgaris during the 12-week treatment period, other than the investigational product.
6.Female subjects of childbearing potential (excluding women who are premenarchal, surgically sterilized (by hysterectomy) or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug.
a.For the purpose of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, Depo-Provera® (stabilized for at least 3 months), NuvaRing® (vaginal contraceptive), Implanon™ (contraceptive implant), double barrier methods (e.g., condom and spermicide), IUD, tubal ligation, Essure or abstinence with a 2nd acceptable method of birth control should the subject become sexually active.
b.Subjects on hormonal contraception must be stabilized on the same type for at least three months prior to enrollment in the study and must not change the method during the study
c. A sterile sexual partner is NOT considered an adequate form of birth control.
Full hysterectomy or bilateral oophorectomy considered
surgically sterile. Tubal ligation is not considered equivalent to female sterilization.
7.All male subjects must agree to use acceptable methods of birth control with their partners, from the day of the first dose administration to 30 days after the last dose administration of study drug. Abstinence is an acceptable method of birth control. Female partners should use an acceptable method of birth control as described in criteria 6
8.Subjects must be willing and able to understand and comply with the protocol requirements, including attendance at the required study visits.
9.Subjects must be in good health and free from any clinically significant disease, including but not limited to, conditions that may interfere with the evaluation of acne vulgari
1.Female subjects who are pregnant, nursing or planning to become pregnant during study.
2.Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients.
3.Subjects with presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis.
4.Subjects with excessive facial hair (e.g., beards,sideburns,moustaches,etc.)that would interfere with diagnosis or assessment of acne vulgaris.
5.Subjects with a baseline irritation score of 3 is equal to severe (marked, intense).
6.Subjects who have used within 6 months prior to baseline or use during the study of oral retinoids (e.g.,Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units per day (multivitamins are allowed).
7.Concomitant use planned to use of mega-doses of certain vitamins (such as mega-doses of vitamin D greater than 2000 IU per day, vitamin B6 greater than 2 mg or vitamin B12 greater than 1 mg per day), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
8.Subjects with planned unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.).
9.Use of anti-pruritic, including antihistamines, within 24 hours of baseline visit.
10.Subjects who have had laser therapy, electrodessication, and phototherapy (e.g., ClearLight®) to the facial area within 6 months prior to study entry.
11.Subjects who have received radiation therapy and/or anti-neoplastic agents within 3 months prior to baseline.
12.Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline.
13.Subjects who have used any of the following procedures on the face within 1 month prior to baseline or use during the study:
a. cryodestruction or chemodestruction,
b. dermabrasion,
c. photodynamic therapy,
d. acne surgery,
e. intralesional steroids, or
f. X-ray therapy.
14.Subjects who have used any of the following treatments within 1
month prior to baseline or during the study:
a. spironolactone
b. systemic steroids,
c. systemic antibiotics,
d. systemic treatment for acne vulgaris, or
e. systemic anti-inflammatory agents. If subject uses a
systemic anti-inflammatory product during the study, the
Principal Investigator (PI) will judge if this protocol
violation is clinically significant,
f. have taken any drugs that lower the immune system.
15.Subjects who have used any of the following treatments within 2 weeks prior to baseline or during the study:
a. topical steroids,
b. topical retinoids,
c. topical acne treatments including over-the-counter preparations
d. topical anti-inflammatory agents, or
e. topical antibiotics.
16.Subjects who have done wax depilation of the face within 14 days prior to baseline.
17.Subjects who have had cosmetic procedures (e.g., facials) which may affect the efficacy and safety profile of the investigational product within 14 days prior to study entry.
18.Subjects who have on-going malignancies requiring systemic treatment or who
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion count. <br/ ><br>2 Mean percent change from baseline to week 12 in the Noninflammatory (open and closed comedones) lesion count.. <br/ ><br>Timepoint: Baseline to 12-Week Treatment period
- Secondary Outcome Measures
Name Time Method 1 Proportion of subjects with a clinical response of IGA score at week 12 compared to baseline. <br/ ><br>2 The superiority of the test & reference (active) treatments over placebo (vehicle). <br/ ><br>3 The incidence of treatment-emergent adverse events (TEAEs). <br/ ><br>4 Application site reaction assessments. <br/ ><br>Timepoint: Baseline to 12-Week treatment period