Health Condition 1: L700- Acne vulgaris
Conditions
Interventions
Intervention1: Topical Minocycline hydrochloride gel 4%: Once a day at night 1 hour before bedtime for 12 weeks.
Control Intervention1: Clindamycin Phosphate 1% gel: Once daily preferably at similar t
Sponsors
Dr Deval Mistry
Eligibility
Inclusion criteria
Inclusion criteria: Patients eligible for enrolment in the study must meet all of the following criteria: 1) Patients aged 9 years or more, of either gender diagnosed with acne vulgaris defined by: a) Grade 1-4 of acne Grade 1: Comedones, occasional papules. Grade 2: Papules, comedones, few pustules. Grade 3: Predominant pustules, nodules, abscesses. Grade 4: Mainly cysts, abscesses, widespread scarring. b) IGA score of 0-5 0: Clear 1: Almost Clear 2: Mild 3: Moderate 4: Severe 5: Very Severe 2) Patients who will refrain from use of any other acne medication, medicated cleanser, excessive sun exposure for the duration of the study. 3) Patients who are willing to use effective contraceptive method for the duration of the study. 4) Patients/their parents/legal guardians/representatives willing to give consent/assent to participate in the study.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria must not be enrolled in the study: 1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations. 2. Severe systemic disease as assessed by the Investigator that might interfere with the conduct of the study or the interpretation of the results. 3. Sunburn on the face. 4. Female patients who are pregnant, lactating, or planning a pregnancy. 5. Patients who have a documented history or known case of any of the following: a. Allergy to tetracycline-class antibiotics or to any ingredient in the study drug. b. Pseudomembranous colitis or antibiotic-associated colitis. c. Known or suspected premalignant or malignant disease (excluding successfully treated skin cancers). 6. Clinically significant hepatic impairment (ALT & AST values >3 times upper limit)/renal impairment (eGFR ( 7. Patients who have used the following medications: Within 1 week prior to screening: a) Medicated facial cleansers on the face. b) Topical acne treatments on the face (other than those listed below). Within 4 weeks prior to screening: a) Topical retinoid (e.g. tretinoin, tazarotene, adapalene) on the face. b) Topical antimicrobials (e.g. clindamycin, erythromycin) c) Topical anti-inflammatories and/or corticosteroids on the face, benzoyl peroxide, salicylic acid, �±-hydroxy/glycolic acid d) Systemic antibiotics (Minocycline, doxycycline). e) Systemic acne treatments. Within 12 weeks prior to screening: a) Systemic retinoid. b) Systemic corticosteroids c) Estrogens or change in oral contraceptives therapy 8. Have received an investigational therapy (including investigational drug or procedure) and vaccines including COVID-19 vaccine within 28 days of screening or plan to use one during the study. 9. Refusal to participation expressed by patient or legal guardian/representative.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of topical minocycline gel 4% vs clindamycin phosphate gel 1% in Indian patients with acne vulgaris. a) Change from baseline in the inflammatory & non-inflammatory lesion count at Weeks 3, 6, 9 and 12. b) Investigator Global Assessment (IGA) treatment success (dichotomized as yes/no) at weeks 3, 6, 9 and 12, where success is defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline at weeks 3, 6, 9 and 12 weeks. c) Change in scores of Acne QOL from baseline to Week 12 d) Percentage of patients who respond to either parameters of Subject satisfaction questionnaire at Week 12.Timepoint: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| a) To compare the local skin tolerability (erythema, dryness, hyperpigmentation, skin peeling, pruritus) of topical minocycline gel 4% vs clindamycin phosphate gel 1% in Indian patients with acne vulgaris ââ?¬â?? [Time Frame: Weeks 3, 6,9 and 12] b) To compare the safety of topical minocycline gel 4% vs clindamycin phosphate gel 1% in Indian patients with acne vulgaris. c) Number of adverse events (AEs), serious adverse events (SAEs), treatment related AEs and SAEs and AEs leading to dose modification/discontinuation of treatment [Time Frame: up to 12 weeks]Timepoint: Week 12 | — |
Countries
India
Contacts
Public ContactDr Deval Mistry
Dr R.R. Gupta and Dr Deval Mistry s Skin Clinic
Outcome results
None listed