A Efficacy and Safety of Duac™Compared With Clindamycin P... | NCT01915732

Label	Type	Description	Intervention Names
Duac™Once Daily Gel	Experimental	Subjects will use Duac™Once Daily Gel (once daily in the evening)for 12 weeks. The subjects will be evaluated for change in lesion counts, ISGA, SGA , local tolerability, and AEs/SAEs at Weeks0, 1, 2, 4, 8, and 12 (or at early withdrawal). In addition, quality of life measures will be performed at every study visit	Drug: 1% clindamycin phosphate gel
1% clindamycin phosphate gel	Active Comparator	Subjects will use 1% clinidamycin phosphate gel (twice daily in the morning and evening)for 12 weeks. The subjects will be evaluated for change in lesion counts, ISGA, SGA , local tolerability, and AEs/SAEs at Weeks0, 1, 2, 4, 8, and 12 (or at early withdrawal). In addition, quality of life measures will be performed at every study visit	Drug: Duac™Once Daily Gel

Name	Type	Description	Arm Group Labels	Other Names
Duac™Once Daily Gel	Drug	1% clindamycin as clindamycin phosphate and 5% benzoyl peroxide	1% clindamycin phosphate gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Absolute Change in Total Lesion Count From Baseline to Week 12	The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data.	Baseline (Week 0) and Week 12
Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12	ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.	Baseline (Week 0) and Week 12
Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12	ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data .

Secondary Outcomes

Measure	Description	Time Frame
Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12	The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female subjects between 12 and 45 years of age, inclusive age will be calculated by date of birth, from 0 at birth.
Subjects who have:

i. A minimum of 17 but not more than 60 facial inflammatory lesions (papules plus pustules), and no more than 1 facial nodular lesion, with NO cystic lesions.

and ii. A minimum of 20 but not more than 125 facial noninflammatory lesions (open and closed comedones).
Subjects who have an ISGA score of 2 or 3 at Baseline.
Subjects 18 years of age or older must provide written informed consent (according to any local or national authorization requirements). Subjects under the legal age of consent must provide assent and have written informed consent of both the subject and a parent or the legal guardian (according to any local or national authorization requirements).
Subjects who are willing and able to complete the study, to understand and comply with the requirements of the study, abide by the restrictions, apply the medication as instructed, and return for the required study visits.
Subjects who are in good health and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations.
Female subjects of childbearing potential must have a negative pregnancy test at baseline. Sexually active females of childbearing potential participating in the study must use a medically acceptable method of contraception for at least 6 consecutive months prior to start of study treatment, and must use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Medically acceptable contraceptive methods include the following:
- Hormonal contraception, including oral, injectable, or implantable methods started at least 6 months prior to screening.
- Reliable barrier methods include condoms and diaphragms. A cervical cap is also a reliable barrier method, provided that the female subject has never given birth naturally. The combined use of a condom and spermicide constitute 2 forms of acceptable nonhormonal contraception, provided that they are both used properly. The use of spermicide alone and the improper use of condoms are inferior methods of contraception. Subjects with surgical sterilization, including tubal ligation or partner's vasectomy, must use a form of nonhormonal contraception. A barrier method or sterilization plus spermatocide are acceptable.

Females who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study.

Subjects who have been treated with estrogens, androgens, or anti-androgenic agents used for prevention of pregnancy (and not for control of acne) for at least 6 consecutive months prior to the first dose of investigational product may enrol as long as they do not expect to change dose, drug, or discontinue use during the study.

Exclusion Criteria:

Female subjects who are pregnant, trying to become pregnant, or who are lactating.
Subjects who have cystic acne lesions, acne conglobata, acne fulminans, or secondary acne (e.g. chloracne or drug-induced acne).
Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris.
Subjects who have facial hair that may prevent the accurate assessment of acne vulgaris grade or lesion count.
Subjects who have a history or presence of regional enteritis or inflammatory bowel disease (e.g. ulcerative colitis, pseudomembranous colitis, chronic diarrhoea, or a history of antibiotic-associated colitis, bloody diarrhoea) or similar symptoms.
Subjects who have used a prohibited medication, or undergone a prohibited procedure or treatment within the required washout period.
Subjects who have a known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, or excipients of the investigational product.
Subjects who are employees of a clinical research organization involved in the study, Stiefel, or GSK or who are an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee, the investigator, or his/her study staff.
Subjects who have a member of the same household in this study at the same time.
Subjects who have used traditional remedies known to affect acne vulgaris within the last 4 weeks.
Subjects who have had any major illness within 30 days before study enrolment.
Subjects who have any other condition that in the judgement of the investigator would put the subject at unacceptable risk for participation in the study.
Subjects who have participated in any clinical trials or taken any investigate drugs within 4 weeks before study enrolment.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Guangzhou	Guangdong	510010	China
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
27075705	Derived	Xu JH, Lu QJ, Huang JH, Hao F, Sun QN, Fang H, Gu J, Dong XQ, Zheng J, Luo D, Li FQ, Wang G, Gu H, Tian HQ, Yang HL, Xi LY, Li M, Zheng M, Wu Y, Tu YT, He YL, Zhao G, Sheng WX, Li J, Hamedani AG. A multicentre, randomized, single-blind comparison of topical clindamycin 1%/benzoyl peroxide 5% once-daily gel versus clindamycin 1% twice-daily gel in the treatment of mild to moderate acne vulgaris in Chinese patients. J Eur Acad Dermatol Venereol. 2016 Jul;30(7):1176-82. doi: 10.1111/jdv.13622. Epub 2016 Apr 13.

ID	Title	Description
FG000	Duac Once Daily Gel	Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
FG001	Dalin Gel

ID	Title	Description
BG000	Duac Once Daily Gel	Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
BG001	Dalin Gel	Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000500 BG001516 BG0021016

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Absolute Change in Total Lesion Count From Baseline to Week 12

The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data.

Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication.

Posted

Least Squares Mean

Standard Error

Change in lesion count

Baseline (Week 0) and Week 12

ID	Title	Description
OG000	Duac Once Daily Gel	Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
OG001	Dalin Gel	Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.

Units	Counts
Participants	OG000484 OG001499

Title

Denominators

Categories

Title	Measurements
	OG000-55.7± 1.05 OG001-51.2± 1.03

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.002		Mean Difference (Final Values)	-4.5			2-Sided	95	-7.4	-1.6				No	Superiority or Other

Primary

Absolute Change in Total Lesion Count From Baseline to Week 12

Per-Protocol (PP) Population: all participants included in the ITT Population who did not have a noteworthy protocol deviation that influenced effect.

Posted

Least Squares Mean

Standard Error

Change in lesion count

Baseline (Week 0) and Week 12

ID	Title	Description
OG000	Duac Once Daily Gel	Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
OG001	Dalin Gel	Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.

Primary

Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12

ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.

ITT Population

Posted

Number

Participants

Baseline (Week 0) and Week 12

ID	Title	Description
OG000	Duac Once Daily Gel	Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
OG001	Dalin Gel	Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.

Primary

Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12

PP Population

Posted

Number

Participants

Baseline (Week 0) and Week 12

ID	Title	Description
OG000	Duac Once Daily Gel	Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
OG001	Dalin Gel	Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.

Secondary

Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12

The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.

ITT Population

Posted

Least Squares Mean

Standard Error

Lesions

Baseline (Week 0) and Week 12

ID	Title	Description
OG000	Duac Once Daily Gel	Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
OG001	Dalin Gel	Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.

Units	Counts

Secondary

Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12

PP Population

Posted

Least Squares Mean

Standard Error

Lesions

Baseline (Week 0) and Week 12

ID	Title	Description
OG000	Duac Once Daily Gel	Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
OG001	Dalin Gel	Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.

Units	Counts

Secondary

Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12

The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones) and total lesions (the sum of ILs and NILs)at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.

ITT Population

Posted

Least Squares Mean

Standard Error

Percent change in lesions

Baseline (Week 0) and Week 12

ID	Title	Description
OG000	Duac Once Daily Gel	Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
OG001	Dalin Gel	Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.

Secondary

Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12

PP Population

Posted

Least Squares Mean

Standard Error

Percent change in lesions

Baseline (Week 0) and Week 12

ID	Title	Description
OG000	Duac Once Daily Gel	Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
OG001	Dalin Gel	Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.

Secondary

Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12

The assessor evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.

ITT Population

Posted

Number

Participants

Week 12

ID	Title	Description
OG000	Duac Once Daily Gel	Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
OG001	Dalin Gel	Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.

Units	Counts

Secondary

Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12

PP Population

Posted

Number

Participants

Week 12

ID	Title	Description
OG000	Duac Once Daily Gel	Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
OG001	Dalin Gel	Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.

Units	Counts

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Application site erythema	General disorders	MedDRA	Systematic Assessment	EG00026 affected500 at risk EG0014 affected516 at risk
Application site pruritus	General disorders	MedDRA	Systematic Assessment	EG00016 affected500 at risk EG0013 affected516 at risk
Application site swelling	General disorders	MedDRA	Systematic Assessment	EG00013 affected500 at risk EG0013 affected516 at risk
Application site erosion	General disorders	MedDRA	Systematic Assessment	EG0006 affected500 at risk EG0011 affected516 at risk
Application site pain	General disorders	MedDRA	Systematic Assessment	EG0006 affected500 at risk EG0012 affected516 at risk
Application site dryness	General disorders	MedDRA	Systematic Assessment	EG0004 affected500 at risk EG0010 affected516 at risk
Application site warmth	General disorders	MedDRA	Systematic Assessment	EG0004 affected500 at risk EG0010 affected516 at risk
Application site dermatitis	General disorders	MedDRA	Systematic Assessment	EG0003 affected500 at risk EG0011 affected516 at risk
Application site reaction	General disorders	MedDRA	Systematic Assessment	EG0001 affected500 at risk EG0010 affected516 at risk
Hyperhidrosis	General disorders	MedDRA	Systematic Assessment	EG0001 affected500 at risk EG0010 affected516 at risk
Hyperpyrexia	General disorders	MedDRA	Systematic Assessment	EG0001 affected500 at risk EG0010 affected516 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0001 affected500 at risk EG0012 affected516 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00013 affected500 at risk EG00113 affected516 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected500 at risk EG0012 affected516 at risk
Herpes simplex	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected500 at risk EG0010 affected516 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected500 at risk EG0010 affected516 at risk
Nasal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected500 at risk EG0010 affected516 at risk
Onychomycosis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected500 at risk EG0010 affected516 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected500 at risk EG0014 affected516 at risk
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected500 at risk EG0011 affected516 at risk
Rash pustular	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected500 at risk EG0011 affected516 at risk
Rhinitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected500 at risk EG0011 affected516 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected500 at risk EG0010 affected516 at risk
Dry mouth	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected500 at risk EG0010 affected516 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected500 at risk EG0011 affected516 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected500 at risk EG0011 affected516 at risk
Cheilitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected500 at risk EG0011 affected516 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected500 at risk EG0011 affected516 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected500 at risk EG0015 affected516 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected500 at risk EG0011 affected516 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected500 at risk EG0011 affected516 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected500 at risk EG0011 affected516 at risk
Retching	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected500 at risk EG0011 affected516 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected500 at risk EG0010 affected516 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected500 at risk EG0012 affected516 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected500 at risk EG0011 affected516 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected500 at risk EG0010 affected516 at risk
Rash vesicular	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected500 at risk EG0010 affected516 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected500 at risk EG0011 affected516 at risk
Papule	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected500 at risk EG0011 affected516 at risk
Injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected500 at risk EG0010 affected516 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected500 at risk EG0011 affected516 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected500 at risk EG0011 affected516 at risk
Eyelid oedema	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected500 at risk EG0010 affected516 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected500 at risk EG0010 affected516 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected500 at risk EG0010 affected516 at risk
Eyelid operation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 affected500 at risk EG0010 affected516 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected500 at risk EG0011 affected516 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected500 at risk EG0011 affected516 at risk

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Duac Once Daily Gel	Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.			1	500	71	500
EG001	Dalin Gel	Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.			0	516	41	516