To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel

• Sponsor: Cadila Healthcare Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02005666
• Collaborator: (none)
• Enrollment: 850
• Locations: 36
• Arms: 3
• Duration (Months): 34.9
• Patients Per Site: 23.6
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel; Drug: DUAC® Gel; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 850 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo Controlled, Three Arm Clinical Study to Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel (of Cadila Healthcare Limited, India) Versus DUAC® Gel (of Stiefel Laboratories, USA) Versus Placebo (Vehicle Gel) in the Ratio of 2:2:1 Respectively, in Patients With Acne Vulgaris
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Sep 28, 2016
• Actual Study Completion Date: Sep 28, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test-Cadila healthcare limited Drug:-Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days	Drug: Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel; Drug:-1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days; Other Names: 1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of CHL
Active Comparator: Reference Drug:-DUAC® Gel (of Stiefel Laboratories, USA) Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days	Drug: DUAC® Gel; Drug:-DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days; Other Names: DUAC® Gel (of Stiefel Laboratories
Placebo Comparator: Placebo Drug:-Placebo (Vehicle Gel) Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days	Drug: Placebo; Drug:-Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days; Other Names: Placebo (Vehicle Gel)

Outcome Measures

Primary Outcome Measures

1. Mean Percent Change From Baseline to Week 11 (Study Day 77) for Inflammatory (Papules and Pustules) Lesions. [week 11]

   Mean percent change from baseline to week 11 (study Day 77) for inflammatory (papules and pustules) lesions in PP populations. The primary endpoint of the study is mean percent change from baseline to week 11 (study Day 77) in the inflammatory (papules and pustules) lesion count. Papule was Inflammatory lesion; small (< 5mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule was Inflammatory lesion; small (< 5mm in diameter), inflamed skin swelling that is filled with pus. The test product was judged therapeutically equivalent to the reference product in the reduction of inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)

Secondary Outcome Measures

1. Mean Percent Change From Baseline to Week 11 in the Non-inflammatory Lesion Count [week 11]

   Mean percent change from baseline to week 11 in the non-inflammatory lesion count. The mean percent change from baseline to week 11 in the non-inflammatory (open and closed comedones) lesion count in per protocol population . The analysis was same as the analysis performed for the mean percent reduction from baseline to Day 77 in the number of inflammatory lesion count. Closed Comedone was Non-inflammatory lesion; whitehead, skin-colored or slightly inflamed "bump" in the skin. Open Comedone was Non-inflammatory lesion; blackhead, surface of the plugged sebaceous follicle has a blackish appearance. The test product was judged therapeutically equivalent to the reference product in the reduction of Non inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)

2. Proportion of Subjects With a Clinical Response of "Success" at Week 11 [Week 11]

   Success was defined as an Investigator Global Assessment (IGA) score that is at least 2 grades less than the baseline assessment. Percentage of subjects with at least 2 grades improvement in IGA scoring from baseline to week 11 for test, reference and placebo in Per protocol population. IGA is evaluated in the range of 0 to 4. Grade 0=Clear skin with no inflammatory or non-inflammatory lesions;Grade 1=Almost clear;rare non-inflammatory lesions with no more than one small inflammatory lesion; Grade 2 = Mild severity; greater than grade 1;some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions);Grade 3 = Moderate severity; greater than Grade 2; up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion;Grade 4= Severe; greater than Grade 3;up to many non-inflammatory lesions and may have some inflammatory lesions,but no more than a few nodular lesions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of Acne vulgaris

2. 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).

3. Investigator's Global Assessment (IGA) of acne severity grade 2, 3 OR 4

4. Willing to refrain from use of all other topical acne medications or antibiotics during the 11 week treatment period.

5. If female of childbearing potential, willing to use an acceptable form of birth control during the study.

6. 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.

7. Willing to provide written informed consent or assent (HIPAA consent/authorization, as applicable)

Exclusion Criteria:

1. 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).

2. Patients who have acne conglobata, acne fulminans and secondary acne (e.g.: chloracne and drug induced acne).

3. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Well trimmed moustaches are allowed.

4. History of hypersensitivity or allergy to benzoyl peroxide or clindamycin and/or any of the study medication ingredients.

5. Patients who have a severe or intense irritation on the Face.

6. 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).

7. 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.

8. 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,

1. acne surgery, 5) intralesional steroids, or 6) x-ray therapy.

1. 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.

2. Use within 2 weeks prior to baseline (Randomization) of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations,

1. topical anti-inflammatory agents, 5) medicated cleansers or 6) topical antibiotics.

1. 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).

2. 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.

3. 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.

4. Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study.

5. Concomitant use of tanning booths or sunbathing.

6. A significant medical history of or are currently immunocompromised

7. Have any systemic or dermatologic disease that may affect the evaluation of study results.

8. Have a history of regional enteritis, ulcerative colitis, pseudomembranous colitis or antibiotic-associated colitis.

9. Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.

10. Subjects who engage in activities that involve excessive or prolonged exposure to sunlight.

11. Subjects with History of Alcohol abuse or other drugs of abuse within 2 years prior to Randomization.

12. Female subjects who are breast-feeding or planning to become pregnant.

13. Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrollment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universal BioPharma Research	Dinuba	California	United States	93618
2	Research Across America	Santa Ana	California	United States	92705
3	Visions Clinical Research	Boynton Beach	Florida	United States	33472
4	Dermatology Research Instititue	Coral Gables	Florida	United States	33146
5	International Dermatology Research, Inc.	Miami	Florida	United States	33144
6	The Indiana Clinical Trials Center	Plainfield	Indiana	United States	46168
7	Dermatology Specialists	Louisville	Kentucky	United States	40202
8	Minnesota Clinical Study Center	Fridley	Minnesota	United States	55432
9	Skin Specialists, PC	Omaha	Nebraska	United States	68144
10	Academic Dermatology Associates	Albuquerque	New Mexico	United States	87106
11	Yardley Dermatology Associates	Yardley	Pennsylvania	United States	19067
12	Discover Research	Bryan	Texas	United States	77802
13	Osmania General Hospital	Hyderabad	Andhra Pradesh	India	500012
14	Gandhi Hospital,	Hyderabad	Andhra Pradesh	India	500048
15	King George Hospital	Visakhapatnam	Andrapradesh	India	530002
16	Maulana Azad Medical College	New Delhi	Delhi	India	110002
17	NHL Medical College and VS Hospital	Ahmedabad	Gujarat	India	380006
18	AMC-MET Medical College, Sheth LG General Hospital,	Ahmedabad	Gujarat	India	380008
19	Sanjeevani Hospital,	Ahmedabad	Gujarat	India	380015
20	Dept of Dermatology, Leprosy and STI, Civil Hospital and BJ Medical College,	Ahmedabad	Gujarat	India	380016
21	Dept of Dermatology, BYL Nair Hospital and TN medical college, Dr ALNair Road, Mumbai Central,	Mumbai	Gujarat	India	400 008
22	Department of Dermatology, New Civil Hospital and Government Medical College	Surat	Gujarat	India	395001
23	Baroda Medical College	Vadodara	Gujarat	India	390001
24	Dept of Dermatology, Bhagawan Mahaveer Jain Hospital Millers Road,Vasanthnagar -	Bangalore	Karnataka	India	560 052
25	Dept of Dermatology, Kempegowda Institute of Medical Sciences	Bangalore	Karnataka	India	560004
26	Sapthagiri Hospital,	Bangalore	Karnataka	India	560073
27	Dept of Skin & STD, JSS Hospital Ramanuja Road, -	Mysore	Karnataka	India	570004
28	Government Medical Collge	Nagpur	Maharashtra	India	440003
29	NKP Salve Institute of Medical Siences and Lata Mangeshkar Hospital,	Nagpur	Maharashtra	India	440019
30	Dr. D Y Patil Hospital and Research Center	Navi Mumbai	Maharashtra	India	400706
31	Jehangir Clinical Development Center	Pune	Maharashtra	India	411001
32	Medipoint Hosp	Pune	Maharashtra	India	411007.
33	Postgraduate Institute of Medical Education & Research (PGIMER)	Chandigarh	Punjab	India	160012
34	M.V. Hospital and research Center	Lucknow	Uttar Pradesh	India	226003
35	Institute of Post graduate medical and Research	Kolkata	West Bengal	India	700020
36	Ganga Ram Hospital,	Delhi		India	110 060

Sponsors and Collaborators

• Cadila Healthcare Limited

Investigators

• Study Director: Dr Dharmesh Domadia, M.D, Cliantha Research Limited

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 1. Feldman S, Careccia RE, Barham KL, et al. Diagnosis and treatment of acne. Am Fam Physician
• 2. NilFroushzadeh MA, Siadat AH, Baradaran EH, Moradi S. Clindamycin lotion alone versus combination lotion of clindamycin phosphate plus Tretinoin versus combination lotion of clindamycin phosphate plus salicylic acid in the topical treatment of mild to
• 3. Irby CE, Yentzer BA, Feldman SR. A Review of Adapalene in the Treatment of Acne Vulgaris. Journal of Adolescent Health
• 6. Barza M, Goldstein JA, Kane A. Systemic absorption of clindamycin hydrochloride after topical application. Journal of the American Academy of Dermatology
• Cleocin T® Prescribing Information
• Guin JD, Lummis WL. Comedonal levels of free clindamycin following topical treatment with a 1% solution of clindamycin phosphate. Journal of the American Academy of Dermatology
• Plaisnce KI, Drusano GL, Forrest A, Townsend RJ, Standiford HC. Pharmacokinetic evaluation of two dosage regimens of clindamycin phosphate. Antimicrob Agents Chemother
• Nacht S, Yeung D, Beasley JN, Anjo MD, Maibach HI. Benzoyl peroxide: percutaneous penetration and metabolic disposition. Journal of the American Academy of Dermatology
• DUAC® Gel Prescribing Information
• U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Draft Guidance for Industry: Acne Vulgaris: Developing Drugs for Treatment.

Publications

• Eller MG, Smith RB, Phillips JP. Absorption kinetics of topical clindamycin preparations. Biopharm Drug Dispos. 1989 Sep-Oct;10(5):505-12.
• Zouboulis CC, Fischer TC, Wohlrab J, Barnard J, Alió AB. Study of the efficacy, tolerability, and safety of 2 fixed-dose combination gels in the management of acne vulgaris. Cutis. 2009 Oct;84(4):223-9.

• Responsible Party: Cadila Healthcare Limited
• ClinicalTrials.gov Identifier: NCT02005666
• Other Study ID Numbers: CRL/CT/09/11-12
• First Posted: Dec 9, 2013
• Last Update Posted: Oct 14, 2020
• Last Verified: Feb 1, 2017

• Keywords provided by Cadila Healthcare Limited: Acne Vulgaris; DUAC; CADILA; CLIANTHA
• Additional relevant MeSH terms: Acne Vulgaris; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide

Study Results

Participant Flow

Arm/Group Title	Test-Cadila Healthcare Limited	Reference-DUAC® Gel	Placebo
Arm/Group Description	1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days	DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days	Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
Period Title: Overall Study
STARTED	338	343	169
COMPLETED	311	299	160
NOT COMPLETED	27	44	9

Baseline Characteristics

Arm/Group Title	Test-Cadila Healthcare Limited	Reference-DUAC® Gel	Placebo	Total
Arm/Group Description	1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days	DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days	Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days	Total of all reporting groups
Overall Participants	338	343	169	850
Age, Customized (Count of Participants)
<18	86 25.4%	87 25.4%	47 27.8%	220 25.9%
18 - 40	252 74.6%	256 74.6%	122 72.2%	630 74.1%
41 - 65	0 0%	0 0%	0 0%	0 0%
>65	0 0%	0 0%	0 0%	0 0%
Sex/Gender, Customized (Count of Participants)
Male	186 55%	192 56%	103 60.9%	481 56.6%
Female	152 45%	151 44%	66 39.1%	369 43.4%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska	1 0.3%	1 0.3%	1 0.6%	3 0.4%
Asian	240 71%	245 71.4%	121 71.6%	606 71.3%
Black	9 2.7%	8 2.3%	1 0.6%	18 2.1%
Native Hawaiian or other pacific Islander	1 0.3%	0 0%	1 0.6%	2 0.2%
White	83 24.6%	88 25.7%	45 26.6%	216 25.4%
Other	4 1.2%	1 0.3%	0 0%	5 0.6%
Race/Ethnicity, Customized (Count of Participants)
Hispanic/Latino	44 13%	50 14.6%	23 13.6%	117 13.8%
Non Hispanic/Latino	294 87%	293 85.4%	146 86.4%	733 86.2%

Outcome Measures

1. Primary Outcome

Title	Mean Percent Change From Baseline to Week 11 (Study Day 77) for Inflammatory (Papules and Pustules) Lesions.
Description	Mean percent change from baseline to week 11 (study Day 77) for inflammatory (papules and pustules) lesions in PP populations. The primary endpoint of the study is mean percent change from baseline to week 11 (study Day 77) in the inflammatory (papules and pustules) lesion count. Papule was Inflammatory lesion; small (< 5mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule was Inflammatory lesion; small (< 5mm in diameter), inflamed skin swelling that is filled with pus. The test product was judged therapeutically equivalent to the reference product in the reduction of inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)
Time Frame	week 11

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test-Cadila Healthcare Limited	Reference-DUAC® Gel	Placebo
Arm/Group Description	1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days	DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days	Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
Measure Participants	236	233	128
Mean (Standard Deviation) [percentage of mean change from baseline]	-67.6 (28.39)	-71.3 (25.98)	-51.9 (33.99)

2. Secondary Outcome

Title	Mean Percent Change From Baseline to Week 11 in the Non-inflammatory Lesion Count
Description	Mean percent change from baseline to week 11 in the non-inflammatory lesion count. The mean percent change from baseline to week 11 in the non-inflammatory (open and closed comedones) lesion count in per protocol population . The analysis was same as the analysis performed for the mean percent reduction from baseline to Day 77 in the number of inflammatory lesion count. Closed Comedone was Non-inflammatory lesion; whitehead, skin-colored or slightly inflamed "bump" in the skin. Open Comedone was Non-inflammatory lesion; blackhead, surface of the plugged sebaceous follicle has a blackish appearance. The test product was judged therapeutically equivalent to the reference product in the reduction of Non inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)
Time Frame	week 11

Outcome Measure Data

Analysis Population Description

Total randomized subjects 850,in 2:2:1 ratio(Test:338,Reference:343,Placebo:169).80 subjects withdrawn,770 subjects completed study.Efficacy analysis done in Per Protocol (PP)Population, total 253 subjects were excluded from total randomized subjects.For efficacy analysis,597 subjects considered in PP population (Test:236,Reference:233,Placebo:128)

Arm/Group Title	Test-Cadila Healthcare Limited	Reference-DUAC® Gel	Placebo
Arm/Group Description	1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days	DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days	Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
Measure Participants	236	233	128
Mean (Standard Deviation) [percentage of change]	-61.7 (29.50)	-61.3 (28.46)	-42.0 (34.99)

3. Secondary Outcome

Title	Proportion of Subjects With a Clinical Response of "Success" at Week 11
Description	Success was defined as an Investigator Global Assessment (IGA) score that is at least 2 grades less than the baseline assessment. Percentage of subjects with at least 2 grades improvement in IGA scoring from baseline to week 11 for test, reference and placebo in Per protocol population. IGA is evaluated in the range of 0 to 4. Grade 0=Clear skin with no inflammatory or non-inflammatory lesions;Grade 1=Almost clear;rare non-inflammatory lesions with no more than one small inflammatory lesion; Grade 2 = Mild severity; greater than grade 1;some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions);Grade 3 = Moderate severity; greater than Grade 2; up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion;Grade 4= Severe; greater than Grade 3;up to many non-inflammatory lesions and may have some inflammatory lesions,but no more than a few nodular lesions
Time Frame	Week 11

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test-Cadila Healthcare Limited	Reference-DUAC® Gel	Placebo
Arm/Group Description	1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days	DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days	Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
Measure Participants	236	233	128
Success Rate	40 11.8%	32 9.3%	10 5.9%
Failure Rate	196 58%	201 58.6%	118 69.8%

Adverse Events

Time Frame	Day 1 to Day 78
Arm/Group Title	Test-Cadila Healthcare Limited		Reference-DUAC® Gel		Placebo
Arm/Group Description	1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days Other Name: 1.2% Clindamycin Phosphate/ 5%		DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days		Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
All Cause Mortality
	Test-Cadila Healthcare Limited		Reference-DUAC® Gel		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/338 (0%)		0/343 (0%)		0/169 (0%)
Serious Adverse Events
	Test-Cadila Healthcare Limited		Reference-DUAC® Gel		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/338 (0%)		0/343 (0%)		0/169 (0%)
Other (Not Including Serious) Adverse Events
	Test-Cadila Healthcare Limited		Reference-DUAC® Gel		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	59/338 (17.5%)		61/343 (17.8%)		29/169 (17.2%)
Blood and lymphatic system disorders
Lymphadenopathy	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Ear and labyrinth disorders
Ear deformity acquired	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Eye disorders
Conjunctival haemorrhage	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Scleral cyst	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Gastrointestinal disorders
Abdominal pain upper	1/338 (0.3%)	1	1/343 (0.3%)	1	1/169 (0.6%)	1
Chapped lips	1/338 (0.3%)	1	0/343 (0%)	0	0/169 (0%)	0
Diarrhoea	4/338 (1.2%)	4	1/343 (0.3%)	1	0/169 (0%)	0
Dry mouth	1/338 (0.3%)	1	0/343 (0%)	0	0/169 (0%)	0
Gastritis	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Hyperchlorhydria	2/338 (0.6%)	2	0/343 (0%)	0	0/169 (0%)	0
Nausea	3/338 (0.9%)	3	0/343 (0%)	0	0/169 (0%)	0
Toothache	1/338 (0.3%)	1	0/343 (0%)	0	0/169 (0%)	0
Vomiting	1/338 (0.3%)	1	0/343 (0%)	0	1/169 (0.6%)	1
General disorders
Application site dryness	7/338 (2.1%)	7	7/343 (2%)	7	2/169 (1.2%)	2
Application site erythema	2/338 (0.6%)	2	2/343 (0.6%)	2	4/169 (2.4%)	4
Application site oedema	1/338 (0.3%)	1	1/343 (0.3%)	1	1/169 (0.6%)	1
Application site pain	2/338 (0.6%)	2	3/343 (0.9%)	3	2/169 (1.2%)	2
Application site pruritus	2/338 (0.6%)	2	4/343 (1.2%)	4	3/169 (1.8%)	3
Facial pain	0/338 (0%)	0	2/343 (0.6%)	2	0/169 (0%)	0
Fatigue	1/338 (0.3%)	1	0/343 (0%)	0	0/169 (0%)	0
Pain	1/338 (0.3%)	1	1/343 (0.3%)	1	0/169 (0%)	0
Pyrexia	7/338 (2.1%)	7	2/343 (0.6%)	2	2/169 (1.2%)	2
Immune system disorders
Hypersensitivity	0/338 (0%)	0	0/343 (0%)	0	1/169 (0.6%)	1
Seasonal allergy	1/338 (0.3%)	1	0/343 (0%)	0	0/169 (0%)	0
Infections and infestations
Bronchitis	0/338 (0%)	0	0/343 (0%)	0	1/169 (0.6%)	1
Conjunctivitis	1/338 (0.3%)	1	1/343 (0.3%)	1	0/169 (0%)	0
Cystitis	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Ear infection	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Gastroenteritis	1/338 (0.3%)	1	1/343 (0.3%)	1	0/169 (0%)	0
Gastroenteritis viral	0/338 (0%)	0	0/343 (0%)	0	1/169 (0.6%)	1
Gastrointestinal viral infection	0/338 (0%)	0	0/343 (0%)	0	1/169 (0.6%)	1
Influenza	0/338 (0%)	0	2/343 (0.6%)	2	0/169 (0%)	0
Nasopharyngitis	11/338 (3.3%)	11	10/343 (2.9%)	10	2/169 (1.2%)	2
Otitis media	1/338 (0.3%)	1	0/343 (0%)	0	0/169 (0%)	0
Pharyngitis streptococcal	0/338 (0%)	0	2/343 (0.6%)	2	0/169 (0%)	0
Sinusitis	1/338 (0.3%)	1	0/343 (0%)	0	0/169 (0%)	0
Tonsillitis	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Upper respiratory tract infection	2/338 (0.6%)	2	2/343 (0.6%)	2	0/169 (0%)	0
Urinary tract infection	1/338 (0.3%)	1	0/343 (0%)	0	1/169 (0.6%)	1
Staphylococcal infection	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Injury, poisoning and procedural complications
Animal bite	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Concussion	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Heat stroke	0/338 (0%)	0	0/343 (0%)	0	1/169 (0.6%)	1
Muscle strain	0/338 (0%)	0	0/343 (0%)	0	1/169 (0.6%)	1
Road traffic accident	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Investigations
Alanine aminotransferase increased	1/338 (0.3%)	1	0/343 (0%)	0	0/169 (0%)	0
Aspartate aminotransferase increased	1/338 (0.3%)	1	0/343 (0%)	0	0/169 (0%)	0
Eosinophil count increased	1/338 (0.3%)	1	0/343 (0%)	0	0/169 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	1/338 (0.3%)	1	0/343 (0%)	0	0/169 (0%)	0
Back pain	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Myalgia	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Neck pain	0/338 (0%)	0	1/343 (0.3%)	1	1/169 (0.6%)	1
Pain in extremity	1/338 (0.3%)	1	2/343 (0.6%)	2	1/169 (0.6%)	1
Pain in Jaw	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Nervous system disorders
Dizziness	1/338 (0.3%)	1	0/343 (0%)	0	0/169 (0%)	0
Headache	9/338 (2.7%)	9	15/343 (4.4%)	15	6/169 (3.6%)	6
Product Issues
Device dislocation	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Psychiatric disorders
Depression	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Reproductive system and breast disorders
Breast tenderness	1/338 (0.3%)	1	0/343 (0%)	0	0/169 (0%)	0
Dysmenorrhoea	2/338 (0.6%)	2	1/343 (0.3%)	1	0/169 (0%)	0
Pelvic pain	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Vaginal discharge	1/338 (0.3%)	1	0/343 (0%)	0	0/169 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	2/338 (0.6%)	2	1/343 (0.3%)	1	1/169 (0.6%)	1
Nasal congestion	3/338 (0.9%)	3	0/343 (0%)	0	0/169 (0%)	0
Oropharyngeal pain	2/338 (0.6%)	2	1/343 (0.3%)	1	2/169 (1.2%)	2
Rhinorrhoea	3/338 (0.9%)	3	0/343 (0%)	0	1/169 (0.6%)	1
Sinus congestion	1/338 (0.3%)	1	0/343 (0%)	0	0/169 (0%)	0
Throat irritation	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Skin and subcutaneous tissue disorders
Dermatitis contact	1/338 (0.3%)	1	1/343 (0.3%)	1	0/169 (0%)	0
Eczema	1/338 (0.3%)	1	0/343 (0%)	0	0/169 (0%)	0
Erythema	0/338 (0%)	0	1/343 (0.3%)	1	1/169 (0.6%)	1
Mechanical urticaria	0/338 (0%)	0	1/343 (0.3%)	1	0/169 (0%)	0
Rash	1/338 (0.3%)	1	0/343 (0%)	0	1/169 (0.6%)	1
Vascular disorders
Haematoma	1/338 (0.3%)	1	0/343 (0%)	0	0/169 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.