Not yet recruitingNCT07935993Updated Nov 13, 2026

Scalp Serum Paired With HydraFacial HydraScalp Keravive™ Treatment in Patients With Self-Perceived Hair Thinning

An interventional study of HydraScalp Keravive in Hair Loss and Hair Thinning, sponsored by Revision Skincare. Not yet recruiting. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Revision Skincare · Not applicable, Interventional, and Treatment

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase: Not applicable
Study type: Interventional
Enrollment: 15
Allocation: Not applicable
Ages: 30 Years to 50 Years
Sex: All

Study summary

Briefly, this study will evaluate a procedure-pairing regimen consisting of three (3) HydraScalp Keravive™ treatments, administered approximately one (1) month apart, paired with once-daily at-home use of a scalp serum (IP). The IP will also be applied at the study site immediately after each HydraScalp Keravive™ treatment to replace the HydraScalp™ Peptide Complex Spray. Prospective Candidates will be consented and screened at Visit 1/Baseline (V1/BL). After being accepted into the study, subjects will be instructed to stop the use of all products on their scalp per Inclusion Criterion for the duration of the study.

Read the detailed description

At V1/BL, Subjects will report to a Dermatologist, who will classify their hair loss using the Ludwig Scale (females) or Norwood Scale (males) and make BL evaluations of Redness, Dryness, Flaking/Dandruff, and Bumps. Subjects will then rate the Itching, Burning, and Stinging of their scalp and complete a Quality of Life (QOL) questionnaire. A Technician will take standardized clinical photographs and Canfield HairMetrix® images of the scalp before treatment. Subjects will then receive their first HydraScalp Keravive™ treatment, followed immediately application of the IP, after which post-treatment photographs and HairMetrix images will be taken. A Technician will provide the Subject with the IP, Subject Instructions (including treatment instructions), and a Daily-Use Diary before the visit ends. At Visit 2 (V2), Subjects will report to the study site approximately 4 weeks (W4) after their BL visit. Dermatologist and Subject tolerability assessments will be performed, followed by pre-treatment clinical photography and HairMetrix imaging. Subjects will receive their second HydraScalp Keravive™ treatment followed by IP application, and post-treatment clinical photography and HairMetrix imaging will be performed. Subjects will complete an SAQ before the visit ends. At Visit 3 (V3), Subjects will report to the study site approximately 8 weeks (W8) after their BL visit. The same procedures will be performed as at the W4 visit, including the third and final HydraScalp Keravive™ treatment.

At Visit 4 (V4), Subjects will report to the study site approximately 12 weeks (W12) after their BL visit. No HydraScalp Keravive™ treatment will be performed at this visit. Dermatologist and Subject tolerability assessments, clinical photography, and HairMetrix imaging will be performed. Subjects will complete a final SAQ, QOL questionnaire, product attributes questionnaire, and testimonial. Subject's participation in the study will end.

Conditions studied

Hair Loss
Hair Thinning

Browse trials for

Alopecia 512

Keywords

scalp serum
microbiome
hair loss
hair thinning

In context

Alopecia

512 studies on the registry are indexed under Alopecia; 129 are open to participants now.

This study's planned enrollment of 15 is below the median of 50 across 431 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Revision Skincare is the lead sponsor of 20 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 30 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Female or male, 30 to 50 years of age.
Fitzpatrick skin types I-VI.
Is in good general health (physical, mental, and social well-being; not merely the absence of disease); as determined by the PI, based on medical history reported by the Subject.
Has self-perceived moderate to severe thinning hair, either in one area of the scalp or in several areas of the scalp.
Female Subjects: has a score of "I-2" through "Frontal" on the Ludwig Scale, as confirmed by a board-certified dermatologist.
Male Subjects: has a score of "2" through "4" on the Norwood Scale, as confirmed by a board-certified dermatologist.
Has mild to moderate scalp irritation, defined as a score of 1 (mild) or 2 (moderate) on a 4-point scale for Redness, Dryness, Flaking or Dandruff, and Bumps, as determined by a board-certified dermatologist.
Willing to receive three (3) HydraScalp Keravive™ treatments spaced approximately one (1) month apart (BL, W4, and W8).
Willing to use only the study scalp serum on the scalp throughout the study, once daily (morning or evening) plus after every HydraScalp Keravive™ treatment, and to not use any other scalp serum (cosmeceutical or physician-dispensed products).

Exclusion criteria

Exclusion Criteria:

Has scalp severe Redness, Dryness, Flaking, or Bumps scores of 3 (severe) on a 4-point scale, confirmed by a board-certified dermatologist.
Has a scalp severe Itching, Burning, or Stinging score of 3 (severe) on a 4-point scale, as reported by the Subject.
Has any active scalp disease as determined by the Dermatologist (e.g., scalp psoriasis, seborrheic dermatitis, tinea capitis, folliculitis) or any other disease which may interfere, in the Dermatologist's judgement.
Mild to moderate flaking/dandruff meeting Inclusion Criterion 7 is not exclusionary.
Has been diagnosed with Alopecia Areata.
Has hair extensions, weaves, or tight hair styles.
Regularly wears their hair braided or pulled tightly back.
Regularly wears wigs and is unwilling to not wear a wig during the study.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 15 participants (estimated)

Study arms

Experimental
Scalp Serum
Scalp Serum to be applied immediately after HydraScalp Treatment and once daily in the AM or PM on Wet or Dry hair.
Procedure: HydraScalp Keravive

Interventions

ProcedureHydraScalp Keravive
Subjects will receive 3 Hydrascalp Keravive Treatments spaced 1 month apart perofrmed by a licensed aesthetician

What researchers measure

Primary outcomes

Improvement in the appearance of thicker, fuller hair, as measured by clinical photography
Improvement in the appearance of thicker, fuller hair will be measured by Canfield HairMetrix® image analysis and clinical photography at Weeks 4, 8, and 12 compared to baseline, following three (3) HydraScalp Keravive™ treatments paired with once-daily use of the Sponsor's scalp serum. Clinical photography will be assessed for visual improvement in thicker, fuller hair. Canfield HairMetrix images will be analyzed for improvements in hair density, where an increase in score indicates improvement.
Time frame: Week 4, Week 8, and Week 12.
Improvement in hair and scalp attributes measured by subjects through a self-assessment questionnaire
Subjects will complete a self-assessment questionnaire to evaluate perceived improvement in hair and scalp attributes at Weeks 4, 8, and 12. Subjects will be asked to rate a series of statements on a 5 point scale: 1-completely disagree, 2-slightly disagree, 3- neither disagree or agree, 4- agree, and 5-completely agree. The best outcome is to Completely Agree with the statement / question being asked.
Time frame: Week 4, Week 8, and Week 12.
Improvement in subject quality of life measured by a questionnaire
Improvement in Quality of Life (QOL) questionnaire at Week 12 compared to baseline. Subjects will be asked to rate a series of statements on a 5 point scale: 1-completely disagree, 2-slightly disagree, 3- neither disagree or agree, 4- agree, and 5-completely agree. A shift from score 4 - 5 at baseline to score 1 - 3 at post baseline timepoints would indicate an improvement.
Time frame: Week 12

Secondary outcomes

Scalp tolerability measured by objective and subjective parameters on a 4 point scale
Scalp tolerability will be assessed for signs and symptoms of the following objective and subjective irritation parameters. Objective irritation (clinically graded): erythema, dryness, flaking/ dandruff, and bumps. Subjective irritation (assessed by subjects): burning, stinging, and itching. Tolerability will be evaluated using a 4-point scale (0 = none to 3 = severe) at Weeks 4, 8, and 12 compared to baseline. A decrease in value indicates an improvement.
Time frame: Week 4, 8, and 12

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2027, 11 months later.

Of 61 industry-sponsored interventional studies with no phase under Alopecia, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 20. This study's planned 11 months is above that.

Counting every sponsor, half of 146 studies reached it within 12 months; a quarter within 6 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 29, 2026
First posted: Nov 13, 2026
StartEst.: Nov 9, 2026
Primary completionEst.: Nov 7, 2027
CompletionEst.: Nov 7, 2027
Last update: Nov 13, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Registered

First appeared on the registry. No changes since

Nov 13, 2026

Show all 1 update

Nov 13, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07935993
Lead sponsor: Revision Skincare
Responsible party: Sponsor
First posted: Nov 13, 2026
Start date: Nov 9, 2026 (estimated)
Primary completion: Nov 7, 2027 (estimated)
Completion: Nov 7, 2027 (estimated)
Last update: Nov 13, 2026

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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