Clinical trial NCT03853538: A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Face Skin to Recover After Cosmetic Lasering
Official title: Evaluation of the Safety and Efficacy of the Product Bepantol® Derma Spray After the Dermatological Procedure in the Face - 21 Days of Follow-up.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erythema
Skin Recovery
Keywords: Dermal spray
Ablative lasering
Skin hydration
Consumer satisfaction
Sensorial perception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-02-25
Enrollment: 33
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, researchers want to learn more about the effect of dexpanthenol dermal spray on skin recovery and reduction of skin redness after a dermatological procedure (non-ablative laser) on the face for treatment of fine wrinkles, scars, open pores and change of pigmentation.

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

Detailed description: The primary objective is to evaluate the efficacy of the test product to aid skin recovery and reduction of erythema after non-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.

Eligibility criteria: Inclusion Criteria:

* Phototypes I or II according to the Fitzpatrick scale
* Participants willing to perform the dermatological procedure (non-ablative laser) on the face for treatment of fine wrinkles, scars and open pores, rosacea, poikiloderma, and melasma
* 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 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

Primary outcomes:
measure: Transepidermal water loss by TEWL probe
timeFrame: Up to 23 days
measure: Dermic temperature by thermographic camera (FLIR T530sc)
timeFrame: Up to 23 days
Secondary outcomes:
measure: Skin properties of the participants
timeFrame: Up to 23 days
measure: Treatment satisfaction
timeFrame: Up to 23 days
measure: Product evaluation
timeFrame: Up to 23 days
measure: Number of adverse events by dermatological evaluation
timeFrame: Up to 23 days
measure: Number of adverse events by ophthalmologic valuation
timeFrame: Up to 23 days
measure: Severity of adverse events by dermatological evaluation
timeFrame: Up to 23 days
measure: Severity of adverse events by ophthalmologic valuation
timeFrame: Up to 23 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Medcin Instituto da Pele
Study officials:
References: