A study to evaluate the comparison of Tretinoin cream to Retin A and placebo in the acne vulgaris
- Conditions
- Health Condition 1: L988- Other specified disorders of the skin and subcutaneous tissue
- Registration Number
- CTRI/2022/11/047525
- Lead Sponsor
- Aleor Dermaceuticals Limited India (Alembic Pharmaceuticals Limited)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Male or non-pregnant, nonlactating female aged between 12 and 40 years with a clinical diagnosis of acne vulgaris.
2.Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB/IEC approved written informed consent. Subjects 12 to
17 years of age, inclusive, must have provided IRB/IEC approved written assent; this written assent must be accompanied by an IRB/IEC approved written informed consent from the Subjectâ??s
legally acceptable representative (parent or guardian). In addition, all Subjects or their legally acceptable representatives (parent or
guardian) must sign a HIPAA authorization.
3.Subjects must have less than or equal to 25 non-inflammatory lesions (open and closed comedones) AND less than or equal to 20 inflammatory lesions (papules and pustules) AND greater than or equal to 2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the
face. 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).
4.Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigatorâ??s Global Assessment (IGA).
5.Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period, other than the investigational product.
6. Female Subjects of child bearing potential (excluding women who are premenarchal, surgically sterilized (by hysterectomy or bilateral oophorectomy) 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.
7. All male Subjects must agree to use accepted methods of birth control with their partners, from the day of the 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.
8. Subjects must be willing and able to understand and comply with the requirements of the protocol, 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 vulgaris. Such conditions include, but are not limited to the following: auto immune disease; rosacea; seborrheic dermatitis; perioral dermatitis;
corticosteroid-induced acne; carcinoid syndrome; mastocytosis; acneiform eruptions caused by make-up and medication, facial psoriasis and facial eczema.
10.Subjects who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change make-up brand/type or frequency of use throughout the study.
1. Female Subjects who are pregnant, nursing or planning to become pregnant during study participation. Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients. Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (on the face, rosacea, dermatitis, psoriasis, squamous
cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
2. Subjects with excessive facial hair (beards, sideburns, moustaches) that would interfere with diagnosis or assessment of acne vulgaris. Subjects with a baseline irritation score of 3 that is equal to severe (marked, intense), erythema, dryness, burning or stinging, erosion, edema, pain and itching. Subjects who have used
within 6 months prior to baseline or use during the study of oral retinoids (Accutane) ortherapeutic vitamin A supplements of greater
than ten thousand units per day (multivitamins are allowed).
3. Subjects who have had laser therapy, electrodessication and phototherapy (Clear Light) to the facial area within 6 months prior to
study entry. Subjects who have received radiation therapy and (or antineoplastic agents) within 3 months prior to baseline. Subjects who have used for less than 3 months prior to baseline of estrogens or oral contraceptives, use of such therapy must remain constant throughout the study.
4. Subjects who have used any of the following procedures on the face within 1 month prior to baseline or use during the study; cryodestruction or chemodestruction, dermabrasion, photodynamic
therapy, acne surgery, Intralesional steroids, or X-ray therapy.
5. Subjects who have used any of the following procedures on the face within 1 month prior to baseline or use during the study; cryodestruction or chemodestruction, dermabrasion, photodynamic
therapy, acne surgery, Intralesional steroids, or X-ray therapy.
6. Subjects who have used any of the following treatments within 2 weeks prior to baseline or during the study, topical steroids, topical retinoids, topical acne treatments, including over the counter preparations, topical anti inflammatory agents, or topical antibiotics.
Subjects who have used any of the following treatments within 2 weeks prior to baseline or during the study, abradants, peels containing glycolic or other acids, washes or soaps, containing glycolic acid, alpha hydroxy acids, sulfacetamide sodium, non mild facial cleansers, moisturizers that contained retinol. Subjects who
have performed wax depilation of the face within 14 days prior to baseline.
7. Subjects who have had cosmetic procedures (facials) which may affect the efficacy and safety profile of the investigational product
within 14 days prior to study entry. Subjects who have ongoing malignancies requiring systemic treatment or who have any malignancy of the skin of the facial area. Subjects with eczematous
skin.
8. Subjects who currently have or have recently had bacterial folliculitis on the face. Subjects who have unstable medical disorders that are clinically significant or have life threatening diseases, or other medical condition that, in the Investigator opinion, would place the study Subject at undue risk by participation or could jeopardize the integrity of the study evaluations. Sub
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy endpoints are the mean <br/ ><br>percent change from baseline to week 12 in the inflammatory (papules and pustules) and in the non-inflammatory (open and <br/ ><br>closed comedones) lesion countsTimepoint: Baseline to 12-Week treatment period
- Secondary Outcome Measures
Name Time Method Superiority of the Test treatment versus the Vehicle and for the Reference treatment versus the Vehicle.Timepoint: Baseline to 12-Week treatment period