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

Bayer

Status: Completed

Conditions: Erythema; Skin Recovery

Treatments: Drug: BAY207543 (Bepanthol); Other: Semisolid vaseline

Study type: Interventional

Funder types: Industry

Identifiers

NCT03852563

20577

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 2 patient groups

Women_Hemiface BAY207543

Experimental group

Description:

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.

Treatment:

Other: Semisolid vaseline

Drug: BAY207543 (Bepanthol)

Women_Hemiface Vaseline

Active Comparator group

Description:

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.

Treatment:

Other: Semisolid vaseline

Drug: BAY207543 (Bepanthol)