A comparative clinical trial to study the effectiveness of anti-acne drug Tretenoin gel preparation in reducing the incidence of acne recurrence
- Conditions
- Health Condition 1: L700- Acne vulgaris
- Registration Number
- CTRI/2023/04/052062
- 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
Healthy male and non-pregnant, non- lactating female subjects aged 12 to 40 years (both inclusive) and having confirmed diagnosis of Acne Vulgaris.
- Subjects who are willing and able to give their IRB/IEC approved written informed consent/assent (as applicable) to participate in the study. In case of a minor, their parent/guardian is willing and able to give their IRB/IEC approved written informed consent.
- Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits
- Subjects having >= 20 inflammatory (i.e., papules and pustules), >= 25 non-inflammatory (i.e., open and closed comedones) lesions and <= 2 nodulocystic lesions (i.e., nodules and cysts) on the face.
Note: For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. All lesions will be counted, including those present on the nose. Subjects may have acne lesions on other areas of the body which will also be excluded from the count, treatment, and the Investigatorâ??s Global Assessment (IGA) evaluation (e.g., on the back, chest and arms).
- Investigatorâ??s Global Assessment (IGA) of acne severity, grade should be 2, 3 or 4.
- Willing to refrain from use of all other topical products (moisturizer, new brands of make-up, creams, lotions, powders or any other topical product), all acne medications and antibiotics during the 12 weeks treatment period.
- Female subjects of child bearing potential practicing an approved method of contraception and willing to continue its use from study entry to 7 days after the last administration of study drug and have a negative Urine Pregnancy Test at the time of screening or Female subjects of non-child bearing potential.
Note: Approved methods of contraception include Hormonal contraception including oral, systemic injectable or Intra-uterine Contraceptive Devices must have been on a stable dose for 6 months prior to study entry, bilateral tubal ligation or tubectomy, non-hormonal IUCD, double barrier or strict abstinence. Use of oral contraceptive therapy is allowed if it shall remain constant throughout the study. Non-child bearing potential is defined as pre-menarche, postmenopausal absence of menstrual bleeding for 1 year prior to enrolment, hysterectomy or bilateral oophorectomy.
- All male subjects must agree to use accepted methods of birth control with their partners, from the day of first dose administration to 30 days after the last administration of study drug. Abstinence is an acceptable method of birth control. Female partners should use an acceptable method of birth control.
- Subjects who use make-up are ready to use the same brands/types of make-up for minimum period of 14 days prior to study entry and agree to not change make up brand/type or frequency of use throughout the study.
- 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, acne form eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
- Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Well-trimmed moustaches are allowed.
- History of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients
- Use within 6 months prior to baseline of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
- Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study.
- Use on the face within 1 month prior to baseline (Randomization) cryo-destruction or chemo-destruction, dermabrasion / microdermabrasion, photodynamic therapy, acne surgery, intralesional steroids, X-ray therapy.
- Use within 1 month prior to baseline (Randomization) of androgen receptor blockers for acne (spironolactone, Flutamide etc.,), systemic steroids (Including intra-nasal and in-haled corticosteroids), systemic antibiotics, systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout) or systemic anti-inflammatory agents.
- Use within 2 weeks prior to baseline (Randomization) of topical steroids, topical retinoids and topical acne treatments including over-the-counter preparations, topical anti- inflammatory agents, medicated cleansers/shampoo or topical antibiotics.
- Use within 2 weeks prior to baseline (Randomization) of abradants, facials, peels containing glycolic or other acids, masks, washes or soaps, containing glycolic acid, salicylic acid, Alpha- or beta-hydroxy acids or other acids, benzoyl peroxide (BPO) or sulfacetamide sodium, non-mild facial cleansers, moisturizers that contained retinol.
- Subjects who have undergone a facial procedure (e.g., laser peel, microdermabrasion or blue light treatment, etc.) within the past 4 weeks or if it is planned to be performed during the conduct of the study.
- Concomitant use/planned to use of mega-doses of certain vitamins (such as mega-doses of vitamin D [ > 2000 IU/day], vitamin B6 [ > 2 mg] or vitamin B12 [ > 1 mg/day]), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
- Use of tanning booths or tanning lamps or ultraviolet light within 1 week prior to Baseline and an unwillingness to refrain from use during the study.
- Subjects with planned unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.).
- A significant medical history of or are currently immunocompromised or receiving immunomodulators/ biologics since last 3 months.
- Subjects with clinically significant vital sign abnormality.
- Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
- Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
- History of drug or alcohol abuse within last 6 months.
- Use of anti-pruritic, including a
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method