Phase 3
Completed N=850
To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel
Source: ClinicalTrials.gov NCT02005666 ↗Enrolled (actual)
850
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Mean Percent Change From Baseline to Week 11 (Study Day 77) for Inflammatory (Papules and Pustules) Lesions. — -67.6; -71.3; -51.9 percentage of mean change from baseline
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is an Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo Controlled, Three Arm Clinical Study.
The main objective is to evaluate bioequivalence of Test formulation (Clindamycin Phosphate 1.2%/Benzoyl peroxide 5% gel) of Cadila Healthcare with Reference formulation (DUAC® Gel of Stiefel Laboratories)in the ratio of 2:2:1 of Test drug, Reference drug and Placebo respectively.
Total study duration will be for a period of 78 days which includes treatment duration of 77 days.
850 subjects will be enrolled (randomized)as per the inclusion and exclusion criteria mentioned in the protocol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change From Baseline to Week 11 (Study Day 77) for Inflammatory (Papules and Pustules) Lesions. |
-67.6; -71.3; -51.9 | — |
| SECONDARY Mean Percent Change From Baseline to Week 11 in the Non-inflammatory Lesion Count |
-61.7; -61.3; -42.0 | — |
| SECONDARY Proportion of Subjects With a Clinical Response of "Success" at Week 11 |
40; 32; 10; 196; 201; 118 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of Acne vulgaris
- On the face, ≥ 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).
- Investigator's Global Assessment (IGA) of acne severity grade 2, 3 OR 4
- Willing to refrain from use of all other topical acne medications or antibiotics during the 11 week treatment period.
- If female of childbearing potential, willing to use an acceptable form of birth control during the study.
- Have used the same brand of make-up for a minimum period of 2 weeks prior to randomization, for subjects who use make-up, and agree to not change make-up brands or types during the study.
- Willing to provide written informed consent or assent (HIPAA consent/authorization, as applicable)
Exclusion Criteria
- 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, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
- Patients who have acne conglobata, acne fulminans and secondary acne (e.g.: chloracne and drug induced acne).
- 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 benzoyl peroxide or clindamycin and/or any of the study medication ingredients.
- Patients who have a severe or intense irritation on the Face.
- Use within 6 months prior to baseline (Randomization) 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 (Randomization) of estrogens or oral contraceptives; use of such therapy is allowed if it will remain constant throughout the study.
- Use on the face within 1 month prior to baseline (Randomization) or during the study of: 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy.
- Use within 1 month prior to baseline (Randomization) of: 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 5) systemic anti-inflammatory agents.
- Use within 2 weeks prior to baseline (Randomization) of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, 5) medicated cleansers or 6) topical antibiotics.
- Patients who have had general anesthesia for any reason and patients who have received neuromuscular blocking agents within 14 days prior to study entry (Randomization).
- Concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids.
- Concomitant use of mega-doses of certain vitamins (such as vitamin D and vitamin B12), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
- Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study.
- Concomitant use of tanning booths or sunbathing.
- A significant medical history of or are currently immunocompromised
- Have any systemic or dermatologic disease that may affect the evaluation of study results.
- Have a history of regional enteritis, ulcerative colitis, pseudomembranous colitis or antibiotic-associated colitis.
- Subjects with clinically significant unstable medical disorders, life-threatening disease, or cu
Data sourced from ClinicalTrials.gov (NCT02005666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.