CTRI/2021/06/034069
Active, not recruiting
Phase 4
A prospective, multicenter, open label, phase IV study to evaluate safety and efficacy of Adapalene 0.3% - Benzoyl peroxide 2.5% gel in subjects with Moderate to Severe Acne Vulgaris.
ConditionsHealth Condition 1: L700- Acne vulgaris
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: L700- Acne vulgaris
- Sponsor
- GALDERMA India Pvt Ltd
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Male or female subject of at least 12 years old up to 40 years of age inclusive.
- •2\.Subject with clinical diagnosis of moderate to severe facial acne vulgaris, defined by:
- •b. A minimum of 25\-100 inflammatory lesions (papules and pustules); and
- •c. A minimum of 30\-150 non\-inflammatory lesions (open and closed comedones) in total (excluding the nose); and
- •d.No more than two acne nodules (ââ?°Â¥ 1 cm)
- •3\.Female subjects of childbearing potential must have a negative urine pregnancy test (UPT) at Baseline visit (Visit 1\)
- •4\.Female subjects of childbearing potential must practice an effective method of contraception during the clinical trial and at least 1 month after the last clinical trial treatment application: medical contraception \[combined oral contraceptives (estrogens and progesterone) or implanted or injectable contraceptives with stable dose for 1 month prior to clinical trial entry, bilateral tubal ligation, hormonal Intra\-Uterine Device (IUD) inserted at least 1 month prior to clinical trial entry, strict abstinence (1 month prior to trial entry and agrees to continue for the duration of the trial), condom with spermicide, vasectomized partner (for at least 3 months prior to clinical trial entry)
- •5\.Females of non\-childbearing potential, e.g. Premenses, Post\-menopausal (absence of menstrual bleeding for 1 year without any other medical reason), hysterectomy, or bilateral oophorectomy.
- •6\.Subject having read, understood and signed the approved Informed Consent Form (ICF) prior to any participation in the clinical trial. Subject under the age of 18 having signed an assent Form to participate in the clinical trial and their parent(s) or legal representative having read and signed the informed consent form prior to any clinical trial related procedure
- •7\.Subject willing and able to comply with the requirements of the trial protocol, in particular, subject must adhere to the visit schedule, concomitant therapy prohibitions, and must be compliant to the treatment
Exclusion Criteria
- •1\.Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug\-induced acne, etc.), nodule cystic acne, acne requiring systemic treatment,
- •2\.Subject with history of lupus, atopic dermatitis, perioral dermatitis, dermatomyositis, rosacea on the face
- •3\.Prior failure to treatment with Adapalene 0\.3% \- BPO 2\.5% Gel
- •4\.Subject with damaged facial skin (e.g. tattoo, cuts, skin abrasion, eczema or sunburned skin)
- •5\.Female subject who is pregnant, lactating or planning a pregnancy during the trial
- •6\.Subject with known impaired hepatic or renal functions,
- •7\.Subject with a wash\-out period for topical treatment or procedures on the face less than:
- •Topical treatments: Corticosteroids, antibiotics, benzoyl peroxide, azelaic acid, dapsone, hydroxy acids, Zinc containing treatments, , antiseptics, other anti\-inflammatory products or other acne treatments (for example salicylic acid treatments/ transdermal contraceptives are forbidden if used to treat acne)2 weeks Retinoids 4 weeksCosmetic/aesthetic procedures on the face (e.g., comedones extraction, desquamating, or abrasive agents, adhesive cleansing strips) 1 week Wax epilation 2 weeks Photodynamic therapy 6 weeks Laser therapy, microdermabrasion, deep chemical peel, plastic surgery for acne 3 months.
- •8\.Subject with a wash\-out period for systemic treatment less than:
- •Corticosteroids, (except locally acting corticosteroids such as inhaled or intrathecal or dermal application at distance from the face), tetracyclines, other antibiotics (except penicillin) 1 month
Outcomes
Primary Outcomes
Not specified
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