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Trial record 40 of 151 for:    acne AND erythema

Evaluation of Irritation That Could be Caused by Two Facial Gels Applied to Opposite Sides of the Face.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00714714
Recruitment Status : Completed
First Posted : July 14, 2008
Results First Posted : September 2, 2009
Last Update Posted : February 15, 2012
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Brief Summary:
A study to compare the skin irritation potential of two marketed gels for acne treatment, each applied to half of the face of healthy volunteers.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Adapalene Gel Drug: Tretinoin Gel Phase 4

Detailed Description:

At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all subjects will be applying two products on their faces, each on half face. The side of face receiving each product is randomly assigned. One group will use tretinoin facial gel on the left side and adapalene facial gel on the right side of the face daily for two consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for two consecutive weeks after washing with the same study-supplied facial wash.

Subjects will return to the study center every weekday morning for evaluation and for the morning application of both study products. Study personnel will monitor application on the weekdays. There will be a daily clinical evaluation of skin irritation by a blinded dermatologist and by subjects. At baseline and at the end of each week subjects will be photographed and have chromometer readings.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: An Investigator-Blind, Phase 4 Study Assessing the Facial Irritation Potential of Two Acne Treatment Products Using a Split-Face Model
Study Start Date : January 2008
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Tretinoin and Adapalene gels
Adapalene facial gel and tretinoin facial gel applied daily for two weeks on opposite sides of the face (in a split-face model)
Drug: Adapalene Gel
adapalene gel 0.3% topically applied daily in a split-face model for two weeks
Other Name: Differin Gel .3%

Drug: Tretinoin Gel
Tretinoin 0.1% topically applied daily in a split face model for two weeks
Other Name: Retin-A MICRO Gel

Primary Outcome Measures :
  1. Assessment of Facial Irritation and Cutaneous Effects [ Time Frame: cumulative daily weekday scores for two weeks ]
    Cumulative daily weekday scores for two weeks on Expert Grader Assessments: Dryness (0-8, none-deep)and Erythema (0-8, none-severe) and Self-Assessments: Burning/Stinging (0-3, none-severe) and Itching (0-3, none-severe)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy volunteers
  • Before screening, subjects (or legally authorized representative) must read and sign the IRB approved Informed Consent Form (includes HIPPA and Photo release).
  • Subject must have Fitzpatrick Skin Type I, II or III, and judged by the Investigator to have healthy skin.
  • Subject's bilateral facial skin must be clear of any confounding irritation, rashes, acne, rosacea, etc. prior to study start.
  • Subject must be free of systemic retinoids for at least 2 months.
  • Subject must not be using any topical retinoids, systemic antibiotics, nicotinamide or systemic steroids for 1 month prior to study start.
  • All other topical medications to face (e.g., steroids, antimicrobials, salicylic acid, and benzoyl peroxide) and cosmetics containing retinols, AHA's and bleaching agents such as hydroquinone are to be discontinued at least 2 weeks prior to study initiation.
  • Subjects will not apply any emollients and cosmetics to the facial area 24 hours prior to study initiation.
  • Subject must not be planning to become pregnant or nursing before entering the study and during the study period. In addition if using birth control pills, subject must be stabilized for at least 2 months. If subject is of child bearing potential, subject must be using approved method of birth control. Approved methods are birth control pills, implants, patches or spermicide with condoms.

Exclusion Criteria:

  • Subjects who are pregnant or nursing.
  • Subjects who have a grade 1 or more for facial erythema.
  • Subjects who exhibit any skin condition (i.e., atopic dermatitis, seborrheic dermatitis, and psoriasis) or disease that may require concurrent therapy or may confound the evaluation of drug safety or efficacy.
  • Subjects who have a history of hypersensitivity to any of the formulation components listed in Appendix 1.
  • Subjects who have received any experimental drug or used any experimental device 30 days prior to initiation of study therapy.
  • Subjects who have excessive facial hair that may obstruct or hinder the evaluation of any reactions.
  • Subjects who use any known photosensitizing agents.
  • Subjects who presently have skin cancer or actinic keratosis on the face.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00714714

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United States, Pennsylvania
A J&J CPPW Investigational Site
Broomall, Pennsylvania, United States, 19008
Sponsors and Collaborators
Bausch Health Americas, Inc.
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Study Director: Ana B Rossi, MD Johnson & Johnson Consumer & Personal Products Companies, Inc.
Additional Information:
Publications of Results:
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Responsible Party: Bausch Health Americas, Inc. Identifier: NCT00714714    
Other Study ID Numbers: CA-P-5893
First Posted: July 14, 2008    Key Record Dates
Results First Posted: September 2, 2009
Last Update Posted: February 15, 2012
Last Verified: February 2012
Keywords provided by Bausch Health Americas, Inc.:
objective sensory methods
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Antineoplastic Agents
Keratolytic Agents