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Trial record 17 of 32 for:    PANTHENOL

A Study to Gain Information How Well Dexpanthenol Derma Cream Helps the Face Skin to Recover After Cosmetic Lasering

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.
 
ClinicalTrials.gov Identifier: NCT03852563
Recruitment Status : Completed
First Posted : February 25, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

In this study, researchers want to learn more about the effect of dexpanthenol cream on skin recovery and reduction of skin rash after a dermatological procedure (ablative laser) on the face for treatment of fine wrinkles, scars and open pores in adult women.

After the dermatological procedure, participants will return within 3 weeks for 4 visits to the study center to investigate the skin conditions such as redness, irritation, softness and possible side effects. In addition, study participants will be asked about their general acceptance of dexpanthenol cream.


Condition or disease Intervention/treatment Phase
Erythema Skin Recovery Drug: BAY207543 (Bepanthol) Other: Semisolid vaseline Not Applicable

Detailed Description:

The primary objective is to evaluate the efficacy of the test product to aid skin recovery and reduction of erythema after ablative lasering on the face.

Secondary objectives comprise clinical efficacy with respect to skin hydration, softness, vitality, appearance etc. and skin recovery, consumer judgement of product performance and acceptability, and safety.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of the Product Bepantol® Cream After the Dermatological Procedure in the Face.
Actual Study Start Date : March 18, 2019
Actual Primary Completion Date : April 22, 2019
Actual Study Completion Date : April 22, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Petrolatum

Arm Intervention/treatment
Experimental: Women_Hemiface BAY207543
Adult women receive BAY207543 randomized to one hemiface and semisolid vaseline to the other hemiface after ablative skin lasering. The hemiface with BAY207543 is investigated.
Drug: BAY207543 (Bepanthol)
Product is applied to one hemiface.

Other: Semisolid vaseline
Product is applied to one hemiface.

Active Comparator: Women_Hemiface Vaseline
Adult women receive BAY207543 randomized to one hemiface and semisolid vaseline to the other hemiface after ablative skin lasering. The hemiface with vaseline is investigated.
Drug: BAY207543 (Bepanthol)
Product is applied to one hemiface.

Other: Semisolid vaseline
Product is applied to one hemiface.




Primary Outcome Measures :
  1. Transepidermal water loss by TEWL probe [ Time Frame: Up to 23 days ]
    The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300.

  2. Dermic temperature by thermographic camera (FLIR) [ Time Frame: Up to 23 days ]

Secondary Outcome Measures :
  1. Skin properties of the participants [ Time Frame: Up to 23 days ]
    Investigators assess various skin properties of the participants with a questionnaire (each scored from 1 to 5), resulting in an overall efficacy score from 8 to 55 (a higher score represents higher efficacy).

  2. Treatment satisfaction [ Time Frame: Up to 23 days ]
    Participants assess their treatment satisfaction with a questionnaire consisting of 23 items (each item is scored from 1-5) resulting in a score range of 23 to 115 (a higher score represents better treatment satisfaction).

  3. Product evaluation [ Time Frame: Up to 23 days ]
    Participants assess their sensorial perception of different product attributes (e.g. smell, absorption) with a questionnaire consisting of 7 items (each item is scored from 1-5) resulting in a score range from 7 to 35 (a higher score represents higher product satisfaction).

  4. Number of adverse events by dermatological evaluation [ Time Frame: Up to 23 days ]
  5. Number of adverse events by ophthalmologic valuation [ Time Frame: Up to 23 days ]
  6. Severity of adverse events by dermatological evaluation [ Time Frame: Up to 23 days ]
  7. Severity of adverse events by ophthalmologic valuation [ Time Frame: Up to 23 days ]


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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Phototypes I or II according to the Fitzpatrick scale
  • Participants willing to perform the dermatological procedure (ablative laser) on the face for treatment of fine wrinkles, scars and open pores, rosacea
  • Normal eye examination

Exclusion Criteria:

  • Cutaneous pathologies and/or injuries as psoriasis, sensible skin, cancer of the skin, rosacea, atopic dermatitis or other medical criteria to be considered at the moment of the evaluation;
  • Hyperpigmentation and cutaneous marks in the test area that intervenes with the evaluation of possible reactions
  • Active cutaneous pathologies and/or injuries (local and/or disseminated) in the evaluation area
  • Aesthetic or dermatological treatment in the area of evaluation up to 04 weeks before the selection
  • People with entropy, ectropion, stye, conjunctivitis, uveitis or other active eye diseases
  • People with corneal ulcerations, blepharitis, meibomitis, pterygium, trichiasis, distichiasis or other eye diseases of moderate or serious intensity

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 ClinicalTrials.gov identifier (NCT number): NCT03852563


Locations
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Brazil
Medcin Instituto da Pele
Sao Paulo, Brazil, 06023-070
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03852563     History of Changes
Other Study ID Numbers: 20577
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Skin cream
Ablative lasering
Skin hydration
Consumer satisfaction
Sensorial perception
Additional relevant MeSH terms:
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Erythema
Skin Diseases
Skin Manifestations
Signs and Symptoms
Petrolatum
Emollients
Dermatologic Agents