NCT02731105

Brief Summary

Study to compare two gels that are used to treat acne vulgaris. It will be compared the tolerability and effectivity following application of two combination topical acne products clindamycin 1% and 0.025% tretinoin gel (Acnatac® Gel), adapalen 0,1% and benzoyl peroxide 2,5% gel (Epiduo® Gel).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

2.1 years

First QC Date

March 29, 2016

Last Update Submit

October 22, 2018

Conditions

Acne Vulgaris

Keywords

acnevulgarisClindamycinTretinoinAdapalenBenzoylperoxidEpiduoAcnatac

Outcome Measures

Primary Outcomes (1)

  • transepidermal water loss (TEWL)

    3 weeks

Secondary Outcomes (5)

  • Measuring the severity of burning/ stinging and itching using Study Subject Self-Assessment

    3 weeks

  • Measuring and recording the number of acneiform lesions

    3 weeks

  • Measuring health-related quality of life using DLQI-Score/CDLQI

    3 weeks

  • Measuring skin surface pH using pH-Meter

    3 weeks

  • Measuring skin sebum excretion using Sebumeter

    3 weeks

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Acnatac® Gel on left face and Epiduo® Gel on right face once daily for three weeks

Drug: Acnatac® Gel left faceDrug: Epiduo® Gel right face

Arm 2

ACTIVE COMPARATOR

Epiduo® Gel on left face and Acnatac® Gel on right face once daily for three weeks

Drug: Acnatac® Gel right faceDrug: Epiduo® Gel left face

Interventions

Acnatac® Gel left faceDRUG

topical application

Also known as: Clindamycin 1%, Tretinoin 0,025%
Arm 1
Epiduo® Gel right faceDRUG

topical application

Also known as: Adapalen 0,1% and Benzoylperoxid 2,5%
Arm 1
Acnatac® Gel right faceDRUG

topical application

Also known as: Clindamycin 1%, Tretinoin 0,025%
Arm 2
Epiduo® Gel left faceDRUG

topical application

Also known as: Adapalen 0,1% and Benzoylperoxid 2,5%
Arm 2

Eligibility Criteria

Age14 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of mild to moderate facial acne vulgaris at baseline
  • Age: 14 years to 50 years
  • No evidence of facial irritation (erythema, dryness/scaling, burning/itching/stinging) that is not typical for acne vulgaris
  • Willingness to take part in acne study including screening visit and follow up visits on day 0,7, and 21
  • No use of systemic antibiotics, steroids, retinoids and keratolytics within the last 30 days before start of the acne study
  • Patients have to sign personally consent form and follow study procedures
  • Patient is in good general health

You may not qualify if:

  • Female patients who were pregnant, planning to become pregnant or breastfeeding
  • Sexually active female subjects do not use a medically acceptable form of contraception (oral contraception, injectable or implantable methods or intrauterine devices)
  • Female patients who are in childbearing years except post-menopausal (12 month natural amenorrhoea),
  • ▪ postoperative (6 weeks after ovariectomy with or without hysterectomy)
  • regularly and correct use of contraceptive with error rate \< 1 %/year
  • no sex
  • vasectomy of the partner
  • Diseases of the facial skin other than acne
  • No concomitant topical medications (including make-up) or keratolytics as sulphur, salicylic acid, benzoyl peroxide, resorcin and abradents and acid-containing peels one week before the study starts
  • Patients who had facial procedures (chemical peel, laser therapy, photodynamic therapy, microdermabrasion, or UV light therapy) within the past 4 weeks
  • No concomitant participation in other studies within the past 30 days
  • Hypersensitivity against any ingredients of Acnatac® -gel or Epiduo®gel
  • Systemic medication with antibiotics or antibiotics within the last 4 weeks before study start
  • Systemic medication with retinoids within the last 6 months before study start
  • Topical treatment of acne vulgaris within the last two weeks before study
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Carl Gustav Carus; Klinik und Poliklinik für Dermatologie

Dresden, Saxony, 01307, Germany

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clindamycin

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

LincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlycosidesCarbohydrates

Study Officials

  • Roland Aschoff, MD

    Uniklinikum Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 7, 2016

Study Start

February 1, 2015

Primary Completion

February 21, 2017

Study Completion

January 1, 2018

Last Updated

October 23, 2018

Record last verified: 2018-10

Locations

DE(1)