Effects of topical ectoine on skin responses to different laser treatments

ISRCTN	ISRCTN69645337
DOI	https://doi.org/10.1186/ISRCTN69645337
Sponsor	CosmoMed
Funder	CosmoMed

Submission date: 26/08/2026
Registration date: 26/08/2026
Last edited: 18/09/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Izabela Załęska
Principal investigator, Scientific, Public

Petrażyckiego 103 H
Cracow
30-399
Poland

ORCID ID	0000-0001-9607-1345
Phone	+48 (0)504 265 052
Email	izaleska@icloud.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Randomized within-participant (split-body) assignment
Purpose	Treatment
Scientific title	Effects of topical ectoine compared with vehicle on cutaneous responses to different laser treatments in adults: a randomized within-participant controlled study
Study objectives	The primary objective of this study was to evaluate whether topical ectoine modifies cutaneous response and recovery following exposure to different laser modalities. The study assessed the effects of ectoine concentration, timing of application (preconditioning and/or post-treatment), and anatomical treatment site using randomized within-participant comparisons. Secondary objectives included the assessment of changes in skin barrier function, hydration, erythema, pigmentation, and ultrasound-derived skin parameters, as well as the evaluation of facial erythema following vascular laser treatment.
Ethics approval(s)	Approved 12/12/2023, Bioethics Committee at the Regional Medical Chamber in Kraków (Ul. Krupnicza 11 A, Cracow, 31-123, Poland; +48 (0)601485237; bioetyka@oilkrakow.pl), ref: 227/KBL/OIL/2023
Health condition(s) or problem(s) studied	Cutaneous response to laser exposure and subsequent skin recovery, including skin barrier function, hydration, erythema, pigmentation, and skin structural parameters, as well as facial erythema treated with vascular laser therapy
Intervention	Participants underwent controlled laser procedures at predefined anatomical sites using a randomized within-participant design. Different areas within the same participant were assigned to topical ectoine-containing formulations or a corresponding vehicle formulation without ectoine. In the neck study component, one side of the neck was preconditioned with a topical formulation containing 7% ectoine applied twice daily before ablative Er:YAG laser treatment, while the contralateral side received the corresponding vehicle formulation. Skin biophysical parameters were assessed at: T0: before initiation of preconditioning (baseline) T1: after completion of 7 or 14 days of preconditioning, immediately before Er: YAG treatment T2: immediately after Er:YAG treatment T3: 24 h after Er:YAG treatment T4: 7 days after Er:YAG treatment In the facial study component, both sides of the face underwent identical vascular Nd:YAG laser treatment. Following treatment, one side received a topical formulation containing 7% ectoine and the contralateral side received the corresponding vehicle formulation. The assigned formulations were applied twice daily throughout the study period. Participants underwent four laser treatment sessions at 7-day intervals. Skin biophysical parameters were assessed at: T0: before the first Nd:YAG treatment T1: before the third treatment, after the first two therapeutic sessions T2: 7 days after the fourth and final treatment In the décolletage study component, predefined test fields were exposed to different laser modalities and compared across topical formulations containing different ectoine concentrations (1%, 5%, and 7%) and vehicle control. The protocol also evaluated different timing strategies, including ectoine preconditioning before laser exposure and post-treatment application. Skin biophysical parameters were assessed at: T0: before the start of the 7-day preconditioning period T1: immediately after laser exposure T2: 24 hours after exposure T3: 14 days after exposure Treatment allocation to anatomical sides or predefined test areas was randomized according to the respective study component. Cutaneous response and recovery were evaluated using standardized instrumental and imaging assessments at predefined time points.
Intervention type	Mixed
Primary outcome measure(s)	Cutaneous response and recovery following laser exposure measured using instrumental assessment of skin barrier function and cutaneous response using transepidermal water loss (TEWL), corneometry, erythema index, USG and standardized skin imaging at baseline and predefined post-intervention follow-up timepoints according to each study component (see Interventions field for the full list)
Key secondary outcome measure(s)
Completion date	25/03/2024

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	29 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	90
Total final enrolment	90
Key inclusion criteria	1. Adults aged 29–65 years 2. Male and female participants 3. Fitzpatrick skin phototype II 4. Healthy skin in the anatomical areas selected for experimental laser exposure, where applicable 5. Presence of facial erythema suitable for vascular Nd:YAG laser treatment for participants included in the facial study component 6. Eligibility to undergo the laser procedures specified in the respective study component 7. Ability and willingness to comply with the study procedures, topical product application regimen, and scheduled follow-up assessments 8. Provision of written informed consent
Key exclusion criteria	1. Pregnancy or breastfeeding 2. Active skin infection, inflammation, or other clinically significant skin disease in the treatment area 3. Open wounds or impaired skin integrity in the treatment area 4. Known hypersensitivity to any component of the study formulations 5. Contraindications to laser treatment 6. Use of systemic or topical medications known to significantly affect skin healing, inflammatory response, or photosensitivity during the relevant period before or during the study 7. Use of topical retinoids, hydroxy acids, chemical peels, vitamin C preparations, or other biologically active topical products in the treatment area during the study or within the specified washout period 8. Aesthetic, dermatological, or laser procedures in the study areas within the predefined period before enrollment or during the study 9. Excessive ultraviolet exposure or tanning of the treatment areas during the study period 10. Any medical condition considered by the investigator to interfere with safe participation, study assessments, or interpretation of the results
Date of first enrolment	08/01/2024
Date of final enrolment	15/01/2024

Locations

Countries of recruitment

Poland

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

18/09/2026: The target sample size and final enrolment number were corrected from 30 to 90.
26/08/2026: Study's existence confirmed by the Bioethics Committee at the Regional Medical Chamber in Kraków.